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Hearing Of The Health Subcommittee Of The House Energy And Commerce Committee - The 2009 H1N1 Flu Outbreak And The United States Federal Response

Hearing Of The Health Subcommittee Of The House Energy And Commerce
Committee - The 2009 H1N1 Flu Outbreak And The United States Federal

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REP. PALLONE: (Strikes gavel.) The meeting of the subcommittee is called to order. Today we're having a hearing on "2009 H1N1 Flu Outbreak and the U.S. Federal Response." I have to warn you I have to get used to this new definition and not use "swine flu," I understand, anymore. It's -- the subcommittee is meeting to discuss the ongoing 2009 H1N1 flu outbreak and the U.S. federal response, and the purpose of today's hearing is to hear from our nation's leading agencies to learn the what, when and where about this outbreak, and also to discuss next steps in the federal response in reporting and reacting to this potential crisis.

Today we have invited Rear Admiral W. Craig Vanderwagen, assistant secretary for Preparedness and Response; Dr. Joshua Sharfstein, who's the acting commissioner of the Food and Drug Administration; and Rear Admiral Anne Schuchat, who is interim deputy director for the Science and Public Health Program at the Centers for Disease Control and Prevention. And I want to thank each of you for taking time out of your extremely busy schedule to come and help educate Congress and the public about this very serious public health emergency and highlight areas where further support may be necessary.

Now let me tell my colleagues that because the witnesses are on the front line of our ongoing efforts to report and react to the 2009 H1N1 flu outbreak, I'm cognizant time is of the essence and they are needed at their respective offices. Therefore, I have asked all members of the committee to not give an opening statement but instead submit their statements for the record, so that we can get straight to our witnesses and make the best use of their limited time. Without objection, members will have five days to submit their written statements for inclusion in the record hearing.

I am going to recognize, though, the committee chair and subcommittee chairs and the ranking members for remarks, and we'll begin with Mr. Deal.

REP. NATHAN DEAL (R-GA): Thank you, Mr. Chairman, and thank you, distinguished members of our panel. I think we all want to know how to evaluate and know where we are in the ongoing effort to respond to the H1N1 flu situation. And I appreciate the efforts of the chairman and the members of this subcommittee to give us this opportunity to hear update information on what is truly a dynamic and obviously rapidly changing situation.

I recognize the importance of the roles that each of our witnesses play in responding to this public health threat, and so I'm going to keep my comments as brief as possible. I recall not too very long ago this committee was having hearings when we were concerned about the bird flu. And many of the concerns and expressions of preparation necessities that we talked about then I'm sure are applicable here today.

As our witnesses will attest, the threat of a global influenza epidemic, or flu pandemic, is one of the greatest public threats that we face today. From speaking with experts in the field, both in this most recent as well as the most recent past experience with this, we've all said it's not a question of if a flu pandemic will hit, it's a question of when, and I suppose now, what strain will it be.

And I believe that our responsibilities as members of Congress to ensure that the public is protected from this threat as soon as possible and that we take the necessary steps to mitigate its spread is, of course, the heightened risk, and is certainly something that's high on our priorities. And there's no silver bullet. We all know that. But we do want to know what is being done, what should be done, what role can we play.

I encourage -- I am encouraged by the rapid response of the federal and state authorities, who are working closely in conjunction with the private sector to develop solutions to the flu situation that we're facing. In addition to these efforts, I think we have to continue to look for the vulnerabilities that leave the American public at risk.

I have been told that this morning Vice President Joe Biden said in an interview that he'd advise members of his family to avoid commercial air travel, subways and other locations where transmission of flu from person to person is easy. This seems somewhat contrary to the administration's recent statements, and I hope that we can clarify that in this hearing today.

I also hope that we can see how the administration has looked at all available options in dealing with this matter. We certainly need to know, in how to advise our constituents with regard to all of the issues of travel, crossing our national boundaries, and all of the things that go with that.

This is a very distinguished group, and I feel sure that you can answer these questions and many, many more. Thank you for being here. And thank you, Mr. Chairman, for the time.

REP. PALLONE: Thank you, Mr. Deal.

Chairman Waxman?

REP. HENRY WAXMAN (D-CA): Thank you very much, Mr. Chairman. And I thank you for holding this hearing.

It seems to me that at this hearing we must accomplish two things. We should get a clear statement to the public about the flu outbreak from the nation's leading health authorities. And I'm pleased that our witnesses are here today to provide that. We should find out if there are other things, short-term and long-term, that Congress can do to help in their current and future response.

There is much that we cannot know at this point about this flu. We don't know how infection -- how infectious is the virus, or how sick people will get, or how widespread it will be. But there is one thing that can be known: We're better situated to face the outbreak now than we would have been 10 years ago, because of the public health work, the planning, the stockpiles, the building of epidemiological systems. We are better prepared to limit the reach and severity of the epidemic in the U.S. than we would have been. Fewer people will likely get sick than if this same virus had hit in 1990s.

And there is one thing we can confidently predict: We need to do more.

For decades, health professionals have been warning us that we're taking the work of the public health system for granted. The system is generally understaffed, underequipped and underfunded.

The president has requested an additional $1.5 billion to respond to this flu outbreak. And I'm sure the Congress will appropriate these funds. But that should not be the end of our efforts. We should not wait, for public health emergencies, to come up with ad hoc responses.

We should upgrade our public health programs. We should provide them with a firm and reliable foundation of funding. And I hope, from this pandemic flu outbreak, we can finally learn the lesson that public health work saves both money and lives.

I appreciate the witnesses here. And I particularly want to thank Dr. Sharfstein for being here. He was an important staffer, not on this committee but on the Oversight Committee. But it's a rare opportunity to have him on the other side of the table. And I'm pleased that he's here. And I'm pleased that he is in the position he is now holding. And I thank the other two doctors for being with us as well. And we're looking forward to your testimony.

REP. PALLONE: Thank you, Chairman Waxman.

Chairman Dingell.

REPRESENTATIVE JOHN DINGELL (D-MI): Mr. Chairman, thank you. I would ask unanimous consent to insert my full statement into the record. But I'd like to look back on two things.

One, the fact that we've been starving our capabilities of addressing problems of this kind. And we now are looking at the consequences of that situation. And I'd like to observe that the last time we had this kind of serious problem, we had the same kind of potential for a panicky response, which I am observing might be the case again today.

The result of that was a hideous set of consequences in which the lawyers held swine flu seminars, to discuss how it was that they were going to represent plaintiffs and how the situation was going to create the maximum revenue for the plaintiffs and for the lawyers.

I hope that we will have a more measured, thoughtful response -- (inaudible) -- a more careful approach and that from the past events, we will learn that we have to do these things in a more sensible, prudent, provident and continuing manner.

Thank you, Mr. Chairman.

REP. PALLONE: Thank you, Chairman Dingell.

We'll go to the witnesses. I did want to mention though that Congressman Anthony Weiner, you know, called me last weekend.

I think you had a number of cases actually, in a school in your district, and asked that we have this hearing. Obviously a number of members requested it. But I did want to acknowledge his quick action, calling me on the cellphone on Sunday, which, and his concern obviously, because of the number of cases, in the school in his district.

Let me introduce our panel -- and this is the order you're going to be speaking. I guess it's a little different from the way you're sitting there.

First we have Rear Admiral W. Craig Vanderwagen, who is a physician and assistant secretary for preparedness and response. And next is Rear Admiral Anne Schuchat, who is also a physician, and interim deputy director for the Science and Public Health program at the Centers for Disease Control and Prevention. And last is Joshua M. Sharfstein, who is also a physician, and acting commissioner of the Food and Drug Administration. We're asking you to -- basically, for five-minute statements, and they become part of the record.

And we'll start with Admiral Vanderwagen.

ADM. VANDERWAGEN: Good morning, Chairman Pallone and Representative Deal, and thank you for this opportunity to visit with you. I offer greetings and thanks from our new secretary, Sebelius, for this opportunity to assure that both arms of the U.S. government, of the three, are working together and that we can share experiences, concerns and strategies for how we'll address this opportunity.

Over the past week, you've seen extraordinary efforts on the part of Health and Human Services and the rest of the federal government. For the past five years, HHS and the U.S. government made many investments, thanks to the support of Congress, in the nation's preparedness for pandemic influenza.

Now, while the sequence of the events that we've dealt with in the last week -- and I'll remind you we're talking about essentially a week ago yesterday, recognizing two cases in California, to now phase 5 in the WHO environment -- the events of the past week have proven the value of the efforts that you supported, which included the development of community plans, the acquisition of medical countermeasures, the development of new diagnostics and the numerous exercises and response plans at all levels of government.

I'd like to take an opportunity also to acknowledge and thank Secretary Napolitano for her continued leadership in this environment. She's stepped forward very effectively as the principal federal official here, and we work under her guidance overall.

Our new secretary was engaged immediately. She reported to the office yesterday morning. And, in fact, she was briefed and doing press discussions yesterday morning almost immediately. She is actively involved and concerned about these matters and directing our activities as well.

Today I'm joined by my colleagues who currently serve in the HHS leading the response. I want to say just a thing or two about the assistant secretary for preparedness and response. Congress in 2006 established the authority for this responsibility with the notion that this office would be the principal advisor for the secretary on public-health and medical preparedness and response for health emergencies.

And indeed, that's what we're executing at this time. We're trying to work to assure that there is a coherent HHS approach to public health and medical preparedness, and that our response capabilities are coordinated, that the relevant activities of all the operating divisions of Health and Human Services, Centers for Disease Control, Food and Drug Administration, the National Institutes of Health and others are being conducted in a coherent and targeted way on behalf of and subject to the authority of our new secretary.

Our office also serves as the principal entity that coordinates interagency activities between Health and Human Services and other federal departments and agencies, the White House and state and local officials responsible for public health, emergency and medical disaster response.

In the event of a public health emergency such as the 2009 H1N1 flu outbreak, or other medical disasters, Health and Human Services serves as the federal government's lead for all the Emergency Support Function 8; that is, the public health and medical response capabilities under the National Response Framework. As the department's lead for that ESF 8, or Emergency Support Function 8, our office works closely with Homeland Security and FEMA to coordinate all federal assistance to supplement states, territorial governments, tribal and local resources, in response to public health and medical care needs. We manage the secretary's operations center in the Humphrey Building, so that the secretary has moment-by-moment situational awareness and the ability to lead, coordinate and direct as appropriate the health assets that are deployed in support of states.

The response and coordination for the H1N1 flu outbreak is going well. You will hear from Dr. Schuchat how our lead operational entity at this point -- that is, the Centers for Disease Control -- is moving forward according to plan, adjusting to reality as it intrudes, but doing an exceptionally good job of moving forward to manage this event.

The United States governments (sic) are focused on saving lives, slowing the transmission of the disease and mitigating the consequences of this disease. Those are our strategic objectives. Using the guidelines prepared within our pandemic influenza playbooks and plans, we've been able to more clearly communicate our goals, objectives and strategies to our federal, state and local partners, so that we understand what they expect; they understand what they can expect from us. And that makes a ton of difference in making operations flow, and flow well.

As you know, the World Health Organization raised the worldwide pandemic alert to Phase 5, which is characterized by confirmed person- to-person spread of a new influenza virus and able to cause community- level outbreaks. And Dr. Schuchat I'm sure will talk about that in more detail. But prior to that WHO action, we issued several key declarations, including a nationwide public health emergency declaration and four emergency use authorizations, which I think Dr. Sharfstein will talk about in his discussion with you.

These authorizations were issued to make certain diagnostics available to public health and medical personnel, to allow for the use of certain antiviral products and for the use of certain N95 respirators. In response to requests received from affected states, HHS recently released antiviral medications from the Strategic National Stockpile to a large number of states. Additionally, Health and Human Services continues to evaluate community mitigation guidelines in those areas where cases have been confirmed through laboratory analysis.

And as this outbreak progresses, we will continue to assess these and other guidelines, to assure that they are appropriately based on the available science.

Over the coming days, we will continue to work with our federal, state, local and international public health and medical partners, to address the needs of this outbreak.

Many assets, and you will hear elements of this, from my two counterparts, are working to develop a vaccine for this virus. NIH, CDC, FDA and SBIR are all working together, to work this process and to avoid the very dilemma that Mr. Dingell outlined for us.

We will work with several manufacturers, to continue to prepare reference strains, from which viral seeds for vaccine production and clinical trials can be made.

We will not only focus on the immediate response requirements but also those that may lie ahead. As this potentially becomes more of a medical care problem, we will see challenges in the medical care system.

We are already actively in communication, with our colleagues at the state and local level, in hospitals, in emergency rooms and in primary care settings, to anticipate the implementation of their plans, for addressing these matters, and how we can support, enhance and fill gaps that may arise, in that setting.

With that, I will conclude my statement. And you can hear from Dr. Schuchat.

REP. PALLONE: Thank you. I assume that you -- I'm supposed to reference you as doctors rather than admiral. Do you prefer that? Okay.

Dr. Schuchat.

ADM. SCHUCHAT: Good morning, Mr. Chairman and members of the subcommittee. I'm Dr. Anne Schuchat, the acting deputy director for Science and Program at the Centers for Disease Control and Prevention. And I appreciate the opportunity to update you on current steps we're taking, to respond to this unique and serious influenza outbreak.

Our hearts go out to the people in the communities -- within the United States, in Mexico and around the world -- who have been impacted by this new strain of influenza virus.

People are concerned, and we're concerned too. We are responding aggressively -- at the federal, state and local levels -- to understand the complexities of the outbreak and to implement control measures.

Our aggressive actions are possible, in many respects, because of the investments and the support of the committee and the Congress and the hard work of state and local officials, on the front line, around the country.

Flu viruses are extremely unpredictable, making it hard for us, to anticipate the course that this outbreak will have, with any certainty. We do expect increases in the number of cases, the number of states that are affected and the severity of illness.

Amid this uncertainty, we hope to be clear in communicating what we do know and acknowledging the uncertainties -- clearly communicating what we are doing to protect the health of Americans -- and help Americans understand the steps that they can take themselves, to protect their own health and that of their families and their communities.

Influenza arises from a variety of sources, and in this case we've determined that we have a novel 2009 H1N1 virus circulating in both the U.S. and Mexico that contains genetic pieces from four different virus sources. Additional testing is being done on the virus, including a complete genetic sequencing.

CDC has determined that this virus is contagious. It's spreading from human to human, similarly to seasonal influenza, likely through coughing or sneezing. Sometimes people may become infected by touching something with flu virus on it and then touching their mouth or nose.

There's no evidence to suggest that this virus has been found in swine in the United States, and there have been no illnesses attributed to handling or consuming pork. There's no evidence that you can get this new influenza virus from eating pork or pork products.

I want to reiterate that as we look more intensively for cases, we are finding more cases. We fully expect to see not only more cases, but also a greater severity of illness.

The specific numbers are less important in understanding the outbreak than the more general patterns that we observe that will help us guide our intervention.

(Audio break) -- aggressive actions are being taken, here as well as abroad. We're working very closely with state and local public health officials around the U.S. on the investigation, and to implement control measures. We've provided both technical support on epidemiology and laboratory efforts for confirming cases, and we're working with the World Health Organization, the Pan American Health Organization, and the governments of Mexico and Canada on this outbreak. There's a tri-national team that's working in Mexico right now to better understand the outbreak, and to enhance surveillance and lab capacity, so that we can better address critical questions such as why the cases in Mexico appear to be more severe than what we're seeing initially here in the United States. And we're working very closely with other -- HHS and other federal partners to ensure that our efforts are coordinated and effective.

CDC has issued many health advisories for individuals, health- care practitioners, schools and communities, and these continue to evolve as our understanding of the situation changes. On Monday CDC issued a travel health warning for Mexico, recommending that travelers postpone nonessential travel to Mexico. We're also evaluating information from other countries, and we'll update travel notices as necessary.

As always, persons with flu or flu-like symptoms should stay at home and should not attempt to travel. In fact a key message that we have for people is that there's a role for everyone to play when an outbreak like this is occurring. At the individual level it's important for people to understand how each of us can prevent respiratory infections. Frequent hand-washing is an effective way to reduce transmission. If you're sick, stay home. I can't tell you how many times I've said that this week. If your children are sick, have a fever or a flu-like illness, they shouldn't go to school. And if you're ill, you shouldn't get on an airplane or any public transport to travel.

Taking personal responsibility for these things will help reduce the spread of this new virus, as those measures also help reduce the spread of other respiratory infections.

It's also important for people to think ahead, to think about what they would do if this outbreak deepens in their community. Communities, businesses, schools and local government should plan now for what to do if cases appear where you live or work. For example, parents should prepare for what they would do if faced with temporary school closures.

We also have additional community guidance so that clinicians, laboratory scientists and other public-health officials will know what to do should they see cases in their community. All of these specific recommendations, as well as our regular updates, are posted on the CDC's website at

CDC maintains this nation's strategic national stockpile of medications for the eventuality that they may be needed in a situation such as we face today. As part of our pandemic preparedness efforts, the U.S. government has purchased extensive supplies of antiviral drugs. And our preliminary testing indicates that the virus is susceptible to the drugs we have in our stockpile.

We're releasing one-quarter of the states' share of antiviral drugs and personal protective equipment to help states prepare to respond to the outbreak, along with the necessary FDA emergency-use authorities to facilitate their effective use. Distribution has already begun, starting with states where we already had confirmed cases. And the Department of Defense and individual states have also stockpiled these antiviral drugs.

Whenever we see a novel strain of influenza, we begin the steps to work toward the development of a vaccine in case one is needed. The CDC is working to develop a vaccine seed strain specific to this novel virus, which is the first step in vaccine manufacturing. We've initiated steps so that, should we need to manufacture a vaccine, we can work towards that goal very quickly. And rapid progress is being made possible through the combined forces of CDC, NIH, FDA, BARDA and the manufacturing community.

Finally, it's important to recognize that with the strong support of the Congress, there have been enormous efforts in the U.S. to prepare for this kind of outbreak and for a full pandemic. Our detection of this strain in the United States came as a result of that investment. And our enhanced surveillance and laboratory capacity are critical to understanding and mitigating this threat.

While we must remain vigilant throughout this and subsequent outbreaks, it's important to recognize that at no time in our nation's history have we been more prepared to face this kind of challenge. As we face the challenges in the weeks ahead, we look forward to working closely with the subcommittee to best address the evolving situation.

Thank you.

REP. PALLONE: Thank you, Dr. Schuchat.

Dr. Sharfstein.

DR. SHARFSTEIN: Thank you. Chairman Pallone, Ranking Member Deal, Ranking Member Barton, Chairman Waxman, Chairman Dingell and other members of the committee, thank you for having this hearing. I'm Dr. Joshua Sharfstein, principal deputy commissioner and acting commissioner of the U.S. Food and Drug Administration.

FDA protects the public health in this type of situation by facilitating access to safe and effective human and animal drugs, human biological products and devices. FDA is part of a team led by the Department of Health and Human Services. Working closely with the department, our sister agencies, other U.S. government agencies, the World Health Organization and foreign governments, we are responding to this threat.

I appreciate this opportunity to discuss the agency's response, including our approval of several emergency-use authorizations earlier this week and the efforts of several internal FDA teams.

Let me turn to the emergency-use authorizations. Section 564 of the Food, Drug and Cosmetic Act, which was added by the Project BioShield Act of 2004, so I know it came to this committee, permits the FDA commissioners to issue an emergency-use authorization following a determination and declaration of a public-health emergency. This allows the use of an unapproved product or an approved product for an unapproved use in a declared emergency.

REP. PALLONE: Dr. Sharfstein, I think some of the members are having a hard time hearing you. Just pull the mike a little closer to you.

DR. SHARFSTEIN: Sorry about that. Is that better?

REP. PALLONE: That's better, yeah.

DR. SHARFSTEIN: I apologize.

I was talking about emergency-use authorizations. And FDA can issue these in an emergency under four conditions. First, we have to find that the product can cause a serious or life-threatening disease or condition. Second, based on the totality of the scientific evidence, it's reasonable to believe the product will be effective against the disease or condition. Third, that the known and potential benefits of the use outweigh the known and potential risks. And fourth, that there's no adequate approved and available alternative.

This past Sunday, the acting HHS secretary did issue a public- health emergency declaration and then followed that with declarations justifying the emergency use of certain antivirals, in-vitro diagnostics and personal respiratory protection devices. Let me just briefly describe these emergency-use authorizations that FDA went ahead and issued as a result or following on that declaration.

Two of them pertain to drugs. Tamiflu is a drug approved -- it's oseltamivir -- for the treatment of uncomplicated illness due to influenza and prevention of influenza in patients 1 year and older. Relenza is approved to treat acute uncomplicated illness due to influenza in adults and children 7 and older who have been symptomatic for less than two days, and for the prevention of influenza in adults and children 5 years and older.

One of these emergency-use authorizations allows for Tamiflu also to be used to treat and prevent influenza in children under 1 year. In addition, under both authorizations, both of these medications may be distributed with information pertaining to emergency use to large segments of the population without complying with the label requirements that otherwise are applicable to dispense drugs. They may be distributed by a broader range of health-care workers, including some public-health officials and volunteers, in accordance with the state and local laws and public-health emergency responses that I know are being planned around the country.

The third one related to a PCR flu panel diagnostic test for the CDC, which allows the CDC to distribute to public health labs around the country a diagnostic test that can presumptively diagnose this particular infection. And for all of these emergency-use authorizations, the way it worked is CDC applied, we worked very closely with CDC over the weekend to make sure everything was there to get the right information to people, and then we approved them on Monday, starting early in the morning. This particular diagnostic test amplifies the viral genetic material. A positive result indicates presumptive infection; a negative result by itself does not exclude the possibility of infection.

The fourth authorization permits HHS to deploy certain disposable respirators from the Strategic National Stockpile for use to reduce exposure to airborne germs. These products, when used properly and in accordance with information that's provided, may help reduce the chances of getting sick. They do not eliminate the risk of illness or death. They should always be used in conjunction with other infection control measures such as frequent handwashing, and should be done consistently with the advice and guidance provided by the CDC and other public health authorities.

Let me just turn for the last minute to talk about how FDA has organized itself to respond to this challenge.

As soon as we became aware of this last week, I asked Dr. Jesse Goodman, FDA's acting chief scientist and Deputy Commissioner for Scientific and Medical Programs, to coordinate and lead FDA's efforts. Dr. Goodman is a world expert in infectious disease. He previously directed the Center for Biologics and has extensive experience in issues related to influenza vaccine production and evaluation. We've changed the way FDA is managed for this process. We're using an incident management approach, with Dr. Goodman as the leader, which includes seven substantive teams, that are cross-cutting, and include staff from across the FDA and all FDA centers.

These teams work with the Department, CDC, other agencies, national and international partners, and they are the Vaccine Team, the Antiviral Team, the In Vitro Diagnostics Team, the Personal Protection Team, the Blood Team, the Shortage Team and the Consumer Protection Team. We also, in the incident management approach, have an operations section, a logistics section and a communications section. We have senior-level health, international and legal advisers.

Let me just very briefly explain how these teams work:

The Vaccine Team is working to facilitate the availability of a safe and effective vaccine to protect the public from the 2009 H1N1 flu virus as soon as possible. Now, having that vaccine ready is the goal of the team.

There's a completely separate question, and it's going to depend on the status of the epidemic, of whether, and who, we would - that vaccine would be recommended for. But, for FDA, we want to have a vaccine that's safe, effective and available as quickly as possible.

Part of this team starts in the lab. We're growing the vaccine and trying to genetically engineer a reference strain that could be used for vaccine development. We're already preparing a reagent that will be needed to help manufacturers produce and test the vaccine.

We're trying to think through what clinical evidence would be necessary before we can conclude that the vaccine is effective. This team is working with -- BARDA and HHS have extensive consultation with the vaccine industry already as this goes forward.

I actually went out and met with the Vaccines Team earlier this week. They are scientists. They're physicians. They realize how much is at stake for this country.

There's the Antiviral Team, whose goal is to identify and evaluate antiviral drugs to prevent and treat illness, and to facilitate access to these medications. This is the team that led the effort to review the Emergency Use Authorizations with CDC.

They are also in extensive communication with manufacturers about other options to treat this infection -- particularly if it becomes severe, and is working very closely with other regulatory agencies around the world. This team used its expertise to identify the right dose for kids under one. And we're hearing from a lot of countries around the world about -- on how they did that.

We have an In Vitro Diagnostics Team that approved that test I was talking about, that CDC is distributing. It's already working with manufacturers on the availability of other tests, as well as current diagnostics, just for basic identification of influenzae.

The Personal Protective Equipment Team did the -- (inaudible) -- Emergency Use Authorization, and they're also in continuous contact with the key manufacturers to make sure that we can get the appropriate supplies of these products for the American people.

There is a Blood Team. The Blood Team is dedicated to the safety and availability of blood products needed for transfusion by the American public during this outbreak. The main focus of the Blood Team is to make sure there's adequate blood, just in general, because blood is very important for so many different people and patients around the country, and that this -- that the response to this just doesn't reduce the number of donors.

But, they're also starting to think through whether there's any potential risk to the blood supply, and they're engaging other regulatory agencies. So far, they're not -- there's nothing that they're recommending, in terms of particular controls, based on their understanding of influenzae.

We have a Shortage Team that working very closely with manufacturers, particularly around the issue of how they can expand production of key medications, as well as working with HHS and others about shortages that are occurring.

And finally, we have the Consumer Protection Team that cross-cuts across all the different parts of FDA to monitor for scams, dangerous products, and things that may be marketed that could cause harm to people as they're worried about the situation.

So, in conclusion, FDA is fully committed and engaged in protecting the public's health during this difficult time. Among us are laboratory scientists, medical reviewers, epidemiologists, product experts and field inspectors. We will bring every skill and every resource we have to this critical mission.

Thank you very much for the opportunity to testify today. I welcome your ideas and your questions.

REP. PALONE: Thank you, Dr. Sharfstein.

Thank all the panelists.

We now have five-minute questions from the members, and I'll start with myself.

And I wanted to ask Dr. Schuchat, you mentioned the precautions people can take to protect themselves, but could you elaborate further? And let me just ask, what kinds of symptoms should people be alert to? You know, naturally, people look to their families, and, you know, you get all kinds of things: you know, should I go to a doctor; should I wear a mask?

I'm not necessarily -- you don't necessarily have to comment on that, but what are the symptoms that they should be alert to? And what about going to the doctor? Does it make sense to go to a doctor (in) only certain circumstances -- we don't want to overwhelm the doctor's offices either?

DR. SCHUCHAT: The symptoms of this new strain of influenzae virus are similar to the symptoms of seasonal influenzae, and they include high fever, body aches, cough, sore throat, those sorts of things. Unfortunately, the symptoms of influenzae are very nonspecific and they can be caused by lots of other things.

It's important for people to use judgment. If you're really sick, you need to make sure you consult your health care provider. And if your children are ill, the same thing. But, it's also important to recognize that this is a time where we don't want the "worried well" flooding the emergency rooms. We really do need to be careful about that kind of thing.

One of the emphasised (sic) areas has been diagnostics tests to help us differentiate this new virus from other illness. And so we're very pleased that this Emergency Use Authorization went forward and the states are now prepared to differentiate this new flu virus from other things.

But, in general, mild illness, you really are able to stay home in self care. And. illness that's a little bit more severe, you want to make sure you contact your health care provider. In particular, in areas where there hasn't been any recognized disease yet, we want people to let their health care provider know if they have these sorts of symptoms, and have traveled to one of the areas that's affected.

REP. PALONE: Well, you mention Mexico. I mean, I do, I do see -- well, people mention Mexico, obviously, I do see on TV, you know, people in Mexico wearing masks. I mean, that doesn't make -- I mean, maybe it does in Mexico, but here that's a little severe isn't it?

DR. SCHUCHAT: You know, we think there are a variety of interventions that will help reduce the risk of respiratory infections. And we do feel for the people in Mexico, who are in a difficult circumstance now and really doing everything they can think of to try to protect themselves.

Here, we have issued guidance for the mask use for different circumstances. And we update our guidance, as we get new information, on our website. But, I think it's important to say that guidance is going to be different in different areas. The New York City area was having an outbreak in a school that was fairly large, and their guidance was really targeted at the circumstances on the ground.

CDC is trying to issue guidance, and updated guidance, very frequently for the country, but we recognize that the local authorities have the best information on their circumstances. And we really want people to know what's going on in your own community, what do your local authorities say, and really use us as a technical support to those local entities.


Let me ask Dr. Sharfstein about the vaccination. I mean, I seem to recall -- I don't know if it was at the briefing yesterday, that they said that, you know, it probably wouldn't be available for everyone until maybe November at the earliest; possibly not until January.

I remember, in 2004, we had -- when we had a major shortage of the seasonal flu vaccine. And, at the time, the public health officials were saying that if we faced a pandemic, we wouldn't have adequate vaccine capacity.

Can you explain what the government has done to increase the vaccine manufacturing capacity? And, you know, where are we now? I mentioned that -- I don't know where I heard that "November to January," it might have been at the briefing we had yesterday, but if you would comment on it.

DR. SHARFSTEIN: Sure. I'm happy to answer that.

2004, there were only about 60 million doses of vaccine for the flu that year because of the problem that one of the manufacturers had. And, in addition, the infrastructure was relatively weak and there wasn't the capacity, if there was a pandemic, to be making another vaccine. But, because of the committee's efforts, and the federal government's efforts, and FDA's efforts, there's been a tremendous shift since that time.

I'll go through a couple of issues. One, is that there was funding appropriated to strengthen the vaccine infrastructure. And one way to talk about that is eggs. The flu vaccine is made in eggs. And in 2004 there weren't extra eggs. There was just the eggs for the regular flu vaccine.

But, HHS has gone out and contracted -- they have extra flocks, and we've gone to a year-round egg availability. So, there isn't any months where eggs aren't available. So, that reduces most of the time that -- people were worried about in 2004, would be the delay.

On FDA's side, FDA aggressively went out and solicited other companies to be making the flu vaccine for the U.S. market, and using an accelerated approval approach to bring on-line three new manufacturers. So, this year I think the capacity is around 130 (million) or 140 million doses, instead of just 60 (million) in 2004, with additional manufacturing capacity potentially out there, and all the companies already engaged with us in how to make the vaccine and the eggs available.

I was hearing that we now have the capacity -- where we had 200,000 eggs a day only during the flu vaccine season, but that has gone up considerably, maybe as much as 500,000 eggs a day, year round. So, right now the capacity in the system, and the ability of the manufacturers to make vaccine, is so much better than 2004.

The challenge is -- and why people are talking about different dates to when it could become available, has to do more with the virus than anything else. It has to -- there are several steps to make a vaccine and test a vaccine. And each of those has its own uncertainties.

If everything goes, you know, extremely well, we'll all be happy, but we don't know if everything will go extremely well. You could have a problem creating the virus initially, a problem growing the virus. Then, when you make the vaccine you have to test it to see whether it generates the immune response you're looking for or else it may have to be reformulated.

So, I think that the position is -- to explain, is that the infrastructure we're building on is extremely strong, particularly compared to where we were in 2004. But, we're dealing with an unknown virus, when it hasn't been turned into a vaccine before and there's a lot of uncertainty about how that will go. But, it's really a scientific uncertainty. I think the basic infrastructure to succeed is there.

REP. PALONE: Okay, thank you.

Mr. Deal.

REP. DEAL: Dr. Vanderwagen, first of all, I'd like to ask you, how did the administration arrive at the one-and-a-half billion dollars as the figure that the request is made for? How would that money be distributed; to which agencies? What would those agencies be allowed to use that money for? And, are there other funds that HHS can currently draw on to deal with this matter?

MR. VANDERWAGEN: Thank you, Mr. Deal. A good question.

When we analyze the potential demand for additional antivirals, we look at the cost of production of vaccine; we look at the cost of potential medical supplies, should we have a wider, more severe event in the medical environment. When we look at a number of those issues, the cost requirements can be fairly significant.

I think the president's intent was, given that there are all those potential uses, depending upon how this thing progresses, that this was a place to start. I think the majority of that would be looking at such things as additional medications; additional development costs -- you know, associated with the vaccine, and getting it to the point where we have a safe and effective vaccine; and providing some support to local and state requirements for preparedness. I think those are the kinds of issues that we're looking at, in terms of where there funding would go.

And I can tell you --

REP. DEAL: You're not allowed to cough during this hearing. (Laughs.)


REP. DEAL: (Laughs.) I'm joking. You're not allowed to cough during this hearing. (Laughs.)

MR. VANDERWAGEN: Oh, yeah. Well, you know, it's allergies, in my case, not --

REP. DEAL: I got your promise. (Laughs.)

MR. VANDERWAGEN: -- (not the flu ?).

So, the universe of need could be quite large -- much larger than that figure, in fact, but this is a way for us to look at some of the known things that we think we're going to need to take care of.

We are currently replenishing our stockpile for those amounts. We're considering that. We have funds inside the Department we might be able to use to cover that. So, that's a decision point that we're examining right now.

If we want to cover those antivirals that we've already sent to the states, and replenished that, we may have funding available to us internally to do that. But, beyond that, if we're going to start talking about wider support to antivirals, it will be a very difficult challenge to find funding within the existing HHS preparations for that.

REP. DEAL: So, part of it would go to facilitate FDA's more rapid response -- to approving vaccines, for example, for this particular thing, is part of what I hear you say. Is that right?

MR. VANDERWAGEN: Well, the short answer is yes. NIH will conduct clinical studies for safety and efficacy, in partnership with FDA. That takes funding support. We would be looking at beginning to develop the pilot lots. That costs money, to do that particular clinical trial. In series, we'd be looking to try and ramp-up vaccine commercial production capacity while those tests are undertaken. Those all have costs associated with them.

REP. DEAL: All right.

Dr. Sharfstein, from the FDA point of view -- I've been told, and I think the Chairman alluded to this as well, that if we are developing a vaccine specifically for the H1N1 virus, that it could be done as a separate vaccine for that. And I've been told it would take maybe four months to get that -- from the time you arrive at what you think the formula need to be, about four months to get it to production stage. Is that generally about right?

DR. SHARFSTEIN: I think, first of all, let me just follow up on what you said before. There may be extra funds FDA needs, but I want to assure you that everything we think needs to be done is being done. And the management structure we have in place is really pushing, you know, the staff; and everybody is completely committed to doing everything we need to do to meet these different goals, on each team, as quickly as possible.

Four months is one possible scenario. But, what (it) really depends on is how this virus behaves in a vaccine. And I'll just give you an example. We've had to combine it with other viruses in order to get it to grow fast enough. Then, it's got to eventually be grown in bulk. And then it's got to be tested in people to see how much of it produces an immune response.

If you do the first test, and it doesn't show the right -- and it may be the first test, there's a couple different options -- but, based on that data, you have to look at, because our goal is both an effective vaccine and a safe vaccine. So, it's going to -- it's going to depend.

Since we're not going to be waiting for eggs -- that was actually one of the biggest problems in 2004 --

REP. DEAL: I hate to interrupt you, but my time is about out. I want to ask one other thing. My understanding is that each year, in the seasonal vaccines, that you choose up to, maybe, three different strains. I assume this was not one of the strains that was anticipated to be included in the seasonal vaccines, simply because you didn't, first of all, anticipate it; secondly, -- (inaudible) -- not had the time to ramp-up for it.

Are you so far along, I assume, in the seasonal vaccine process, that if you were to be able to come up with a vaccine for this, that it would not be allowed to be included in the seasonal vaccines, but would have to be a separate vaccination program? Is that a correct assumption?

MR. VANDERWAGEN: Well, that's an excellent question. You're right that it was not in the flu vaccine that had been prepared, because people weren't aware of the virus' existence. And right now we're basically developing, with the manufacturers, the ability to make a vaccine, and then there has to be some strategic decisions made over the next few weeks.

One of those decisions is going to be whether to make this as a stand-alone vaccine; to combine it with other vaccines -- and that, in part, has to do with the manufacturing capacity. If you make a single, stand-alone vaccine, you can make more of it. And, in part, that's going to depend on how much of it you need to develop the immune response.

So, there are a lot of factors out there. And what FDA does is it works with CDC, the World Health Organization, and an advisory committee of experts to look at all the evidence; look at what we know about how this vaccine is -- it looks to us, as well as what we know about the manufacturing capacity; and then there will be a recommendation about how this integrates with the seasonal flu.

So, it might -- you know, it's too early right now to have an answer. But, but it is an excellent question, and I think, you know, probably within a few weeks we'll be able to know more and be able to give a better answer.

REP. PALONE: Thank you, Mr. Deal.

Chairman Waxman.

REP. WAXMAN: (Off mike.) Thank you, Mr. Chairman. Thank you, Mr. Chairman.

Dr. Schuchat, I'd like to explore with you how this virus is different from other flu viruses. Most people are familiar with the fact that we have an annual vaccine to deal with the flu that might be in the flu season. And we're in the middle of all this, where the flu season is pretty much over.

Every year millions become ill -- about 36,000 die from the regular seasonal flu in this country, but this new H1N1 flu does appear to be different. And I still recognize we have a lot to learn, but I'm hoping you can clear up a few questions.

Can you explain what the H1N1 flu is, and how it's different from the seasonal flu? Is this virus easily transmitted from person to person? And do we know how dangerous this virus is?

DR. SCHUCHAT: Thank you. This is a new virus that humans have not had before. There are H1N1-A influenzae viruses that we get every year as part of seasonal flu, but this is a new H1N1 strain that we hadn't found before in all of the banks of strains that we've looked at.

It's a very unusual one. It has four genetic components in it: one that comes from swine from North -- from the North America; one that comes from swine from Europe and Asia; a third part that has human origins; and a fourth part that has four -- that has bird origin.

So it's a very unusual virus, and we don't believe that humans have experienced it before until these cases that we're seeing.

It does appear to be easily transmissible in terms of the information we have already here in the United States, as well as in Mexico. But we don't have good information about how dangerous it is -- a very important issue. In Mexico we're getting more data about the severity. In the U.S., we are in early days, but really trying to understand how severe it is. We're taking it very seriously.

REP. WAXMAN: On the news shows, there's a constant comparison to the pandemic flu in 1918 which did such devastation. And it's worrisome when we hear about this comparison, because that virus affected not just the very young and very old, but also affected otherwise healthy adults. Early reports suggest that many of these people who are being hospitalized in Mexico were apparently young and otherwise healthy as well.

I know it's early, but can you tell us in what ways this might be similar to 1918?

DR. SCHUCHAT: A worrisome sign from the early reports in Mexico was the age of the patients and the apparent young, healthy adults. That did ring a bell from the circumstances back in 1918. So far the cases we've had here in the United States that have been laboratory- confirmed are relatively young also. I think our median age is 22 right now. But again, we're beginning to collect more information, and these things could change quite a bit.

There's some very different circumstances from 1918. Today we have antiviral drugs that treat flu. We also have antibiotics or antibacterial drugs that treat the kinds of secondary bacterial pneumonias that we think played a role in the 1918 devastation. We have better health care circumstances. We have much better communication, and hopefully more skilled leadership who is doing the communication.

One of the really important things in addressing something like this is making sure that people have good information and that our interventions are not worse than the virus itself.

REP. WAXMAN: So even if we assume that this virus is as bad as that one in 1918, these modern medical advances will be helpful in treating patients. We're not going to see the same kind of death and terrible results that we saw then when we didn't have vaccines, we didn't have antivirals and we didn't have the whole infrastructure of communication that we now have.

DR. SCHUCHAT: You know, I think that the circumstances are much better today to respond to this kind of thing. I also want to introduce the uncertainty that every new strain is different, and we really need to learn as we go about how this one will behave. We also are mindful of circumstances in other parts of the world which may not be as fortunate as ours.

REP. WAXMAN: And would this virus possibly mutate during the next several months?

DR. SCHUCHAT: Influenza viruses can mutate frequently, and we need to keep our eye on them. So during the regular seasonal flu, we test strains all throughout the season. Often we find changes in the resistance pattern of the virus. We're very happy that the original viruses, the strains that we've tested, are sensitive to the Tamiflu and Relenza that's in our stockpile. But we need to keep looking at that, and we also need to look at the anagenic or immune properties, because that will feature into what vaccine may be useful. So we are -- they do mutate, and we need to keep our eye on that.

REP. WAXMAN: Thank you.

Thank you, Mr. Chairman.

REP. PALLONE: Thank you, Chairman Waxman.

Mr. Gingrey.

REP. PHIL GINGREY (R-GA): Mr. Chairman, thank you.

First of all, let me just associate myself with the comment that our chairman emeritus, John Dingell, made in his opening remarks in regard to not overreacting to the point that we create a pandemic of panic. And I want to thank our panelists. I think already some comments have been made to that regard.

And yesterday, when Secretary Sebelius and Napolitano -- and Dr. Schuchat, you were there as well -- it's very reassuring to members of Congress to get the feeling that we indeed are prepared. The remarks that we heard from Dr. Sharfstein, of course, just add to that.

I feel good about it. I think what occurred in 2003-2004 in regard to the fear of avian influenza pandemic led to a $6 billion emergency appropriation. And as you have pointed out, a lot of that money went toward making sure that a stockpile of Tamiflu and Relenza was beefed up to something like 50 million courses, not just one dose but courses of treatment, and also the three or four pharmaceutical companies who had maybe been in the domestic business of manufacturing vaccine, but because of liability and no reimbursement for the vaccines that were never given, it was not a very cost-effective business for them. We helped with that with grants, and some of that money was spent in that way.

And then it's my understanding -- and this was, of course, what Ranking Member Deal mentioned as far as the $1.5 billion, Dr. Vanderwagen, that $1.3 billion of that original $6 (billion) is still available. And I want to ask this question about that particular amount of money.

President Obama, I think, had no choice, because of the -- he doesn't want to get Katrina, you know, a media frenzy about this issue -- it leaves him no choice but say, "Well, we're not going to go to sleep at the switch and we're going to appropriate this money."

But Dr. Sharfstein, if we decide that it is not really appropriate, not really necessary to go forward with the development of that vaccine specifically against this H1N1 flu -- we won't call it swine flu -- then maybe at some point, when this is all said and done, and it turns out to be a mild disease and people kind of go back to their normal living and they're not shutting down schools because one child is sick and they're not avoiding the subways and taking commercial airline flights -- I mean, you know, we're getting to the point where I fear that we're getting ourselves in a frenzy, and it's inappropriate.

So if this thing turns out not to be the real bad pandemic that everybody fears it could be, then I would hope that the money that's not spent to develop this vaccine will go back to John Q. Taxpayer, go back into the general treasury or whatever, and not just stay there for the next 10 years when it's really not needed.

I don't want to underplay this. I'm a physician member. I don't want to have egg on my face a month from now. But I do agree with Chairman Emeritus Dingell that we don't want to overreact here. And I think Dr. Schuchat mentioned that yesterday and again today. And I would like for all of you to comment on that a little bit, if you would.

DR. SCHUCHAT: I think it's really important to recognize the uncertainty that we have, that influenza can be very unpredictable, that evolution of the situation in the past week has had many worrisome aspects but that we are acting aggressively. And I think that we really do need to make sure that we are able to aggressively respond.

An important issue, I think, is that the investments that were made in the past few years for pandemic preparedness have greatly strengthened our response to seasonal influenza. And as was mentioned, 36,000 Americans die every year from seasonal influenza. So it's likely that flexible programming of emergency funds would be flexibly applied to strengthening our work against the seasonal flu, which is such a killer in America.

DR. SHARFSTEIN: I think that your point is very well taken. And we heard about the analogy of the 1918 flu, but some people have also been discussing the 1976 swine flu situation. In looking back on that, historians have said that might have been an instance where people overreacted.

And the lessons, I think, that were drawn from that experience is that you'd better separate out the preparation for the possible worst- case scenario from actually implementing it and that people, in looking back, felt like maybe because they had a vaccine, they had to use it. And I think it's very clear now that those two things have got to be separated.

It's, in the end, going to be okay if we have a vaccine but it turns out not to be a pandemic. We just don't want to be in a situation where we have a pandemic and we don't have a vaccine.

DR. VANDERWAGEN: And the last comment, just to finish out your threesome here, sir, I think that we're now down to about 600 million remaining. And most of those -- as you know, we received special milestone payment authority under the Pandemic and All-Hazards Preparedness Act for acquisition of materials and so on.

That balance is really already sort of pre-committed as part of those milestone payments, which are going for diagnostics, new antivirals in case we develop resistance to the existing antivirals, and to support some other vaccine analysis that's ongoing. So it's committed in the milestone payments stream for those products that are in development.

REP. PALLONE: Thank you.

We just have one vote. I'm going to try to proceed with questions. I'm going to see if there's some way that we can work it out so that we don't have to break, but I don't know if that's possible. But in the meantime, if we'll proceed to Chairman Dingell.

REP. DINGELL: Thank you for your courtesy, and I commend you for the hearing.

I have several questions I'd like to have for the record, and I would ask unanimous consent that the responses be inserted in the record at the appropriate place and fashion.

The first one: Who is going to be the lead agency? Is it going to be HHS or is it going to be the Department of Homeland Security?

DR. VANDERWAGEN: The simple answer is, for public health and medical activities, it's Health and Human Services. For the wider response, if it involves energy, transportation, security, et cetera, that's all in the hands of DHS. We all work as a coherent team under their leadership.

REP. DINGELL: Do you have a memorandum of understanding to finding how that's going to be done?

DR. VANDERWAGEN: Yes, sir, there's the --

REP. DINGELL: Would you submit that?

DR. VANDERWAGEN: -- national response framework with a very specific set of requirements --

REP. DINGELL: Would you please submit that for the record?

How is this budget going to be expended? Would you submit to us a statement of how the money is going to be expended, if you please?

Now, the states are going to have a very severe problem. My home state of Michigan has a budget deficit which has been announced is going to go to a billion dollars after some very savage efforts to cut back on the expenditures. How much of this money, this billion and a half dollars, is going to go to the states to be expended through their agencies, for what purposes?

DR. SCHUCHAT: You know, I think these matters are being evaluated, and the Office of Management and Budget is intending to submit something soon with those types of allocations.

REP. DINGELL: So the answer is we don't know. And I'm assuming that the answer is that you do not yet have a defined budget structure.

There's no nod button on the recorder's response. The answer is yes. Is that right?

All right. Now, what is the potential for this flu outbreak to reach pandemic levels?

DR. SCHUCHAT: The World Health Organization elevated the phase yesterday to phase five, which is the second-highest phase. But here in the United States we've already been acting as if it were a full- blown pandemic in terms of our response, aggressively preparing for widespread disease in many communities. We don't know if that will actually happen, but we are seeing sustained transmission in a few communities. We don't yet have severe illness, but we -- or lots of severe illness -- but we fear that we may have additional severe cases, as we have with seasonal flu.

REP. DINGELL: I would like to have you submit to the committee, as soon as you can, what assistance the federal government is going to be providing state and local units of government to enable them to address their responsibilities in this matter of flu. I ask unanimous consent that that be inserted in the record at the appropriate place.

I note that FDA is currently using three products whose use is being vigorously monitored. The secretary was granted emergency use under the 2004 Project Biofuel law to clear the unapproved use of particular products in the event of an emergency. The secretary is exercising this authority for two drug products and one diagnostic test.

What are the considerations in deciding to clear the products for use of young children and adults? This is for Dr. Sharfstein.

DR. SHARFSTEIN: Thank you for the question. The basic considerations are set out in the law, and then I'll tell you how we applied it in this case. First of all, there's a serious or life- threatening condition -- we know that's the case; second, that the totality of the scientific evidence makes it reasonable to believe that the product may be effective; third, that the known and potential benefits of the use outweigh the known and potential risks; and fourth, there is no adequate approved and available alternative.

Now, for kids, the only thing that is done differently under the emergency use authorization is for Tamiflu, where it permits the use under age 1. And it's an excellent question, because you think, well, how did FDA decide that that was okay? How (did you ?) figure out a dose? It was not in the original label.

And it turns out that FDA has been looking at this for a couple of years and has been working very closely with NIH and the company to get data on under age 1. And there was actually a study that was done. FDA reviewed this study, and even over the weekend got additional data from the company involving more than 750 infants from Japan and also some German data. There was a study that was organized out of NIH which was specifically targeted for kids under --

REP. DINGELL: Please submit the rest of your question for the answer -- or rather for the record.

I would like to know if your agency has a regular on-the-shelf plan to address these kinds of problems when they arise. Yes or no?

REP. PALLONE: Chairman Dingell, if I could just interrupt and tell the members, what we're going to do is continue, because of the time constraint of our public health witnesses here. And Ms. Capps, who is our vice chair, is going to come back and replace me so I can go vote.

You will all have about eight minutes left. If you want to leave now and come back -- I don't mean the witnesses; I'm talking about the members -- we're just going to continue.

I apologize for interrupting, Mr. Chairman.

REP. DINGELL: I'll repeat the question. I would appreciate for you submitting for the record, one, the answer, do you have an on-the- shelf plan? You're nodding yes?

MR. VANDERWAGEN: Yes is the answer.

DR. SCHUCHAT: Yes, all of us do.

REP. DINGELL: All right. All three of you?


REP. DINGELL: All right. And does that include working with the Department of Homeland Security?


REP. DINGELL: And do they have one?


REP. DINGELL: All right. Would you submit those plans to us for the record, please?


REP. DINGELL: Mr. Chairman, I thank you.

REP. PALLONE: Next is Mr. Murphy.

REP. TIM MURPHY (R-PA): Thank you, Mr. Chairman. I want to thank all the distinguished panelists. I'm learning a great deal here. I'm not a physician. I'm a psychologist, and I understand panic. And I need to ask you some questions. I'm not meaning to embarrass anyone, but I think it's very important you get some official statements out for this.

Is anyone from any of your departments recommending that any American citizens avoid airplanes, buses, elevators, confined spaces? Or do you think that perhaps we should not be saying that right now?

DR. SCHUCHAT: We are recommending that people defer non- essential travel to Mexico. We're recommending that people who are sick not get on airplanes or public transportation. And I think there may have been a misstatement.

REP. MURPHY: Would you all agree with that?


REP. MURPHY: We'll let it stand at that. But I do think it's important we let people know this is -- every year when there's a flu in this country, many people die, sadly, from that. But the main thing is to understand that you're working this issue very hard, and I appreciate what you're doing.

However, it is a concern about any time people will use transportation. And I'm wondering, as part of your plan, we have the transportation security system set up. Every airport has lots of posters on lots of issues. And I'm wondering (as a citizen ?) if you're recommending people not travel if they're sick, stay home if they're sick, if the airports are a particularly important area because that's where you have people who may be ill traveling across the country and spreading this.

Is this part of your plan to also include that as a location for other public information posters, perhaps, at airports? And added to that, anything you're advising airlines with regard to if they see passengers come to the airport that appear to be sick?

DR. SCHUCHAT: Yes, we've been issuing both guidance as well as developing materials. We've also started to hand out the yellow cards, the travel health alert notices, at airports and other ports for people who are traveling to know what signs to look for and what to do if they do become ill. And we're certainly -- we actually just recently issued guidance for airline crews, if they were caring for someone who was ill, what are the steps they need to take. And we'll continue to update those kinds of guidances.

REP. MURPHY: Would this include information that airport security or airline workers, if they see someone who appears to be ill before they get on a plane, perhaps tell them not to fly?

DR. SCHUCHAT: Yes, that's right. We actually do already have quite a bit of intervention in terms of education for the travel workers, the Customs and Border Protection personnel, as well as a good relationship with the airline industry.

We developed a greater collaboration during the SARS problem to really be able to make sure people working on that profession could recognize the issues and address them.

REP. MURPHY: And one other thing -- and open it up to other comments as well -- certainly we are aware of those things that our parents taught us. You cover your mouth if you sneeze. You stay home. You wash your hands. I see you have your little bottle there. You've been using that very effectively there, Doctor.

But are there things you advise people not to do? For example, should people go out and get Tamiflu and just start taking it? Should people start taking other antibiotics if they have some in their medicine cabinet? What kind of things are not a good idea for people to do? I wonder if you could comment on that.

DR. SCHUCHAT: You know, at this point we're recommending that drugs like Tamiflu, which is an anti-flu viral or antiviral drug against the flu or antibiotics against bacterial infections be taken under a doctor's advise.

REP. MURPHY: Are antibiotics useful at with the flu?

DR. SCHUCHAT: Influenza is a viral infection and antibiotics treat bacterial infections. Some people suffering influenza can later develop a secondary or late-onset --

REP. MURPHY: Such as pneumonia.

DR. SCHUCHAT: -- pneumonia caused by a bacteria. So there are circumstances later on, following influenza, where antibiotic treatment might be necessary, but this would all be under a doctor's advice.

REP. MURPHY: Again, I'm asking the panel in this so that some people may call into their doctor and saying, can you give me a prescription for antibiotics? I've got some in medicine cabinet. I was sick last year. Should I start taking them? What would you all advise prophylactically?

DR. VANDERWAGEN: We would advise people to not self-medicate. That they should seek consultation with their physician before they take any medical intervention. And we're advising them that this is a doctor-patient relationship that has to be worked through, rather than just arbitrarily deciding to medicate yourself.

REP. MURPHY: Do you agree with that too, Doctor?

Thank you. I appreciate that. It is important that -- I don't know people to take this too lightly nor too seriously. We've had the SARS issue; we also had the avian influenza issue. These are good, important issues that people need to be addressing and I do appreciate the important medical, commonsense information we'd be sending out to Americans.

Thank you so much.

DR. SHARFSTEIN: I would just add that people can contact their local health departments also to understand what things may be accessible.

REP. CAPPS: Thank you.

The chair now recognizes Congressman Green for five minutes.

REP. GENE GREEN (D-TX): Thank you, Madame Chairman.

And again, I want to thank you. I have a district in Houston, a very urban district. And people go back and forth to Mexico literally every day. But I appreciate the measured response, but also the planning, because our governor just announced a disaster declaration because of the issues. We have two schools now, public schools -- Hamilton Middle School and Harvard Elementary School -- because of a child they shut down the school. So they're being very cautious and that's encouraging. All our districts are planning to do that I think.

One of the concerns I have is that because the experience a few years ago when we didn't have the development of the regular flu vaccine -- and I think Congressman Deal may have mentioned it -- you're not recommending slowing the production of the flu vaccine that we know we typically would be receiving in the fall. This would be a separate injection, if we get to that point?

DR. SHARFSTEIN: Right now there's no recommendation to slow the production. However, as we understand more about the virus, the threat of the new virus, that could potentially change, but it'll be a decision that's made with a lot of external input from a lot of very smart people thinking about what the best balance is going to be.


I know HHS is releasing 25 percent of its reserve of the 50 million courses for antiviral drugs -- Tamiflu and Relenza in the strategic national stockpile. It's my understanding these drugs will be available to all states, prioritizing distribution to the effective states. Is that correct?

DR. SCHUCHAT: Yes, that's right. We've released 11 million of the 44 million doses that were designated for those data project areas and all of the states will be receiving those. Already 11 have either received or are en route, I think.

REP. GREEN: I guess my concern is in Texas we're seeing actually pharmacies who are running out, because of prescriptions. And I'm glad that's happening.

Please, Dr. Vanderwagen.

DR. VANDERWAGEN: Recall that the principles under which we established that stockpile was a partnership with states and that the goal was for we in the states to be able to cover 25 percent of the population for treatment of active disease. That was the principles under which that acquisition was really driven.

And most of the states bought their share. There are a half- dozen states or so that did not, but we're still providing a pro-rata share to all the states in that event. But it's about treatment for people who are sick.

REP. GREEN: I know Texas has 840,000 seven-day courses in antiviral medication and I've heard we qualify for an additional 650,000. Is that generally correct? Do you know on a state-by-state basis?

DR. SCHUCHAT: You know, I guess actually, I just want to correct what I said.

What I know is that nine -- we've completed the shipments to nine states and six of the states completed receipt of shipments in the last 24 hours. But we're continuing to work through the listing, so I don't know the doses.

REP. GREEN: Okay. If you could get that information back to our office. I know Congressman Gonzalez from San Antonio would share the same concern, my colleagues on the Republican side.

DR. SHARFSTEIN: There's one thing I might want to mention just to be clear. You said that some pharmacies were having shortages. And the medicine that is going into the states is going through the public health side not directly to the pharmacies. And it's going to be up to the local and state public health plans how that medicine gets distributed.

REP. GREEN: Well, I guess I (benefit ?). I have a daughter who's an infectious disease fellow at the University of Texas Medical Branch. And she told me Galveston, which is not our district, all the pharmacies in Galveston County were out of the prescriptions. But I don't know about in Harris County, which is Houston, whereas Galveston is separate.

What role should the state play in the distribution of these drugs? So it's going through the public health we have and in fact, that's where I'm getting my information is from the state health commission.

DR. SCHUCHAT: You know, each of the states has a plan for how they're going to do their distribution. So we look to them to let local folks know how it's going to work. But that has been part of the states' pandemic planning efforts.

REP. GREEN: In my last 49 seconds, I know the answer to the question on the H1N1 vaccine and how quickly we can get a development is a couple of months. Two months seems a fairly short time frame for a vaccine to both be tested and it's safe for individuals, whereas Tamiflu was maybe labeled to show adverse psychological affects.

What precautions is the FDA taking to monitor adverse affects from this new vaccine that we're developing now?

DR. SHARFSTEIN: Well, just on Tamiflu there's a team that's looking specifically at Tamiflu adverse affects.

For the flu vaccine it depends if it's -- you know, from the manufacturing standpoint there's a chance that this'll just be produced according to the regular manufacturing approach in which case, you know, every year it has to be done pretty quickly, because every year the flu vaccine is different.

Now, if a different approach has to be taken, that will raise different types of oversight issues. But in all those things -- assuring that, you know, that the risks are outweighed by the benefits and that we think it's a safe vaccine is really the point of our involvement.


Thank you, Madame Chair.

REP. CAPPS: Thank you.

Ms. Blackburn of Tennessee is recognized for her questions.

REP. MARSHA BLACKBURN (R-TN): I want to again thank you all for your patience for being with us yesterday, Dr. Schuchat and then for you all being here this morning to help answer these questions.

We are concerned. In my district in Tennessee we now have a Williamson County case and a Shelby County case. So as you can imagine, as this started to make its way into the news last evening and this morning, I'm hearing from parents and from constituents and medical care providers and health care providers with some questions.

And one of the questions that has been asked of me -- and if you can provide some guidance on how best to answer this I think it would be helpful. The way the process -- the way we understand the process, when a doctor takes a culture, that goes to a state lab. When a state lab suspects that this culture has either the H1 or the N1 and they decide that there is probably cause that it could be the H1N1 strand, that it comes to the CDC for conformation.

Then my question is, number one: How many of those cultures do you have waiting for confirmation? And number two: Once that culture makes it to you, how long does it take for you to provide that confirmation?

DR. SCHUCHAT: Part of our planning is to make sure that we have adequate staff day and night for something like this. And the laboratory staff in the influenza division have been doing -- we've had shifts throughout the night, throughout the weekend.

But we've also taken steps to increase the capacity at the state public health labs with these kits that were recently approved for shipment and started to be shipped on Monday -- it was incredibly quick -- so that more and more state and local areas will be able to do that confirmatory testing on site.

We don't -- the backlog -- we're not working with a backlog. We're really working around the job to make sure that information that's so critical for local decision making is available.

We're also -- we've made many contingency plans for the surge idea so that the state and locals have some capacity through the public health laboratory network. And that also we've got some agreements with commercial labs to help with surge of specimens for sort --

REP. BLACKBURN: Okay. So is it fair to say you all turn this around in a day or a matter of hours? What is the time frame there?

DR. SCHUCHAT: Yes. There are several steps. You know, a doctor will take a test and may get a positive, rapid result or may get a suspicious result, forward that onto the state or local laboratory where the strain needs to grow and additional things happen -- although now, they have these PCR tests that are more rapid.

At that result, things get sent to us. Sometimes the shipping is even one of the longer steps, although we've been really expediting that. And then it's several hours upon receipt in the CDC lab before results would be available.

I may -- things may change over the days ahead as increasing numbers of cases are detected and we really need to make some triage decisions. But at this point with new states wondering, do we have this or not? We're really prioritizing that kind of question that is going to make a difference for a school district, for instance.

REP. BLACKBURN: Dr. Sharfstein?

DR. SHARFSTEIN: Just a follow on: CDC just did an unbelievable job, basically inventing a lab test for this that could be shared with the states within, you know, a couple days. And FDA worked with them so that all the instructions are there, all the quality assurance procedures are there. And now the state public health lab network, which was sort of created to be ready for exactly this, they have the kits.

So for someone in your county, really, it should go to the state lab and they should be -- and they're the ones making the diagnosis. Those samples shouldn't even have to go to CDC anymore.


DR. SHARFSTEIN: And that was all done so quickly to be able to give them that capacity.

REP. BLACKBURN: That is great. So individuals should know within a day, two days? What would be the answer?

DR. SHARFSTEIN: That probably is going to depend on the policy of the state lab.

REP. BLACKBURN: Of the state?



DR. SHARFSTEIN: But the test itself doesn't take more than a few hours. It's a question of how they're handling the cases --

REP. BLACKBURN: All right. And you have both the public labs and the private labs involved in this process?

DR. SCHUCHAT: It wouldn't be the hospital labs. The public state labs or some of the bigger city labs are part of this public lab network. So there are a couple of commercial laboratories that aren't doing that special testing, but they're ready for surge of the original testing.

REP. BLACKBURN: I've got one other question and we may not have time for your to answer it, but we've had questions from several people. This is not flu season in the U.S. And this seems to be a very strong strand and as we move into the warmer months, it may naturally dissipate. But your expectation for when we move into flu season in November, how do we best prepare for a resurgence? Do you think it will come back? Will we have a vaccine by that time? What is the preparation strategy for next year's flu season?

DR. SCHUCHAT: These are really important issues. We are mindful that things may look like they're getting better, but we might have a resurgence in the fall. There are many steps being taken to anticipate that. And part of the efforts of evaluation production of a vaccine is with that in mind.

Also looking to the Southern Hemisphere for what happens there, because they typically have a reverse season from us, and then also understanding the evolution of the virus during the next bit of time.

While flu season is pretty much over in most communities here in the U.S., it's not completely over everywhere. But you're right that we usually don't see cases in the summer, except in people coming back from the Southern Hemisphere and then we will be mindful in the fall.

DR. SHARFSTEIN: I would say we would like to have a vaccine as soon as we can get one. And even if it's -- let's say you have a vaccine, and it doesn't come back in the fall, that's okay. But we don't want to be in a situation if you have a serious problem and you know, you've stopped making the vaccine for some reason. So the plan is to prepare for the worst.

REP. BLACKBURN: Thank you so much.

Thank you, Madame Chairman.

REP. CAPPS: Thank you.

The chair now recognizes the vice chair of this whole committee, Ms. DeGette for questions.

REP. DIANA DEGETTE (D-CO): Thank you, Madame Chair.

I want to congratulate all of you and your agencies for the aggressive efforts and smooth preparations you're taking here.

I've been on this committee now for 12 years and remember quite well the hearings that we had in 1993, '94 and '95. In fact, I've been urging our leadership to have additional hearings so that we could see the progress, and I'm gratified to hear that we have made progress.

I do have a few questions, though, about what will happen.

My first question is do we have a sense of what the incubation period of this virus is?

DR. SCHUCHAT: You know, we're looking at these new cases and the numbers change day to day. Recently, I would say conservatively, two to five days or maybe one to five days.

The idea is that it's a relatively rapid transmission from one person to another.

REP. DEGETTE: One thing I think is -- you know, I have a high school freshman in Denver. And I think at high schools and colleges all around the country many of the students are concerned that if they or someone they knew went to Mexico some weeks ago that that could still be incubating. I think that's important to say -- although, of course, it can be transmitted from person to person here.

My second question is I'm concerned about the fact that while we've come a long way over the last two years -- as Dr. Sharfstein was describing about developing the egg-based vaccines -- I'm concerned that we still have not been able to move to a cell-based production. And I'm wondering if you can talk about what the status of development of a cell-based vaccine?

DR. SHARFSTEIN: Sure. There's been a tremendous investment in cell-based technology. So that was done in parallel with getting the egg capacity up so that the egg-based vaccine could be produced relatively quickly.

There are companies that make cell-based vaccines and FDA is working very closely with them.

REP. DEGETTE: Are you working closely with them to develop cell- based vaccines around this new H1N1 virus?

DR. SHARFSTEIN: Yes, in the sense that we're discussing that with them. But I think that the sense that I'm getting is that because we have a licensed process for the egg vaccine and because we have the egg, that we have a terrific potential capacity to make plenty of vaccine with the traditional approach rather than have to -- and that would be our preference, because we know all the steps in the process.

REP. DEGETTE: Well, except for the fact, Doctor, that if it truly does turn into a pandemic, then having 160 million doses by next January or whenever is not going to be sufficient even for the U.S. population, much less around the world. And so it's great in the short term, but ultimately, we're going to need to move to that cell- based vaccine.

DR. SHARFSTEIN: Your point's very well taken. I think a couple things to say: That's why we're having the conversations with them and that is the future and that's why there's such an investment --

REP. DEGETTE: But it's not going to be the future for this particular strain, correct?

DR. SHARFSTEIN: I wouldn't rule that out. I think that's under discussion. But I think that what I've heard from the vaccine team is that they believe that there's a tremendous potential and it's probably -- the potential's larger than 160 million doses. That 160 million doses are trivalent vaccine, so meaning the three strains. So actually, probably around triple that.

REP. DEGETTE: Okay. But efforts are being made to move to the cell-based --

DR. SHARFSTEIN: Absolutely.

REP. DEGETTE: -- even with this.


REP. DEGETTE: My next question is, is there some potential that this virus could mutate in the summer months between now and the fall when we think we might see a resurgence?

Dr. Schuchat?

DR. SCHUCHAT: Yes, that is possible. And that's why we'll be continuing to look at it.

Just to clarify, the planning assumptions were to have capacity to be able to produce enough vaccine for 300 million people assuming two doses and there are lots of things to be sorted out about how much quantity we're going to need that influence what the real capacity is.

REP. DEGETTE: Right. But again, I'm concerned because if with this old egg-based technology -- which, like I say, I think we've come a long way. I'm not trying to be critical, but if -- heaven forbid -- the virus mutates between now and the fall, then we have to develop a new vaccine and keep with the egg-based technology, we may not have a vaccine developed until next spring and I think that's worrisome to all of us.

Dr. Vanderwagen?

DR. VANDERWAGEN: Ma'am, let me add one or two things to what Dr. Sharfstein has offered you: One is we think 600 million doses is achievable in a six-month time frame. We think that's achievable both in egg-based with some cell-based augmentation.

Part of Congresses investment -- all of the money that was talked about in flu investments, 1.3 billion (dollars) went to the development of cell-based cultures.


DR. SHARFSTEIN: We have two large plants that are very late stage of construction. They are close to inspection, and we've made significant progress with them. Will they be ready by January? I don't know that they will exactly be ready by January, but we know from the existing infrastructure we could probably generate a monovalent 600 million doses in a six-month time frame.

REP. DEGETTE: Thank you. Mr. Chairman, I would hope that these witnesses and their agencies would continue to keep this committee apprised of their development of the cell-based vaccines and their development of the doses as we move forward in the coming months.

REP. PALLONE: I appreciate that, and I'm sure you will.

REP. DEGETTE: Thank you, Mr. Chairman.

REP. PALLONE: Thank you. Our vice chair, Ms. Capps.

REP. CAPPS: Thank you, Mr. Chairman, and thanks to each of you. You've been spending a lot of time in the last couple days on Capitol Hill, and it's very valuable for us to have your expertise and to be kept abreast of what's going on.

A different set of questions from me, please. The recommendations for people, and I'll address it to you, Dr. Vanderwagen. All of you have comments. But I wanted to sort of go from topic to topic. I have three.

The recommendation is that if you have the symptoms, call your health provider; 47 million Americans don't have regular access to a health care. It seems likely that if this progresses and becomes worse, emergency rooms and hospitals, other public places, are going to be on the front lines of receiving all of these patients because they would be the first place, the only place certain people, many people could turn.

Our emergency rooms are already overflowing, and it's clear that responding to a pandemic would be more than they could handle under existing circumstances. Our goal now simultaneously is to work towards providing health care for all Americans, access to health care. In the meantime, I want a comment from you on what kind of emergency coverage, or did you recommend a particular plan that we could speedily enact to provide coverage or in this case of an emergency?

DR. VANDERWAGEN: Well, madam, I really appreciate your linkage between preparedness and health security and health reform.


DR. VANDERWAGEN: Because I think those are intricately, they are intertwined in a way that people don't always realize, and I appreciate that. Medical surge is a function of people, facilities, supplies, equipment and systems. And what we've seen with investments that Congress has appropriated to us in hospital preparedness is, the emergence of systems that rely on the fact that no one place is going to be able to manage the flow. So how do we work collectively to share that flow in a way that takes the burden off?

We've seen extraordinarily good examples of this in a wide variety of states: Illinois, Minnesota, North Carolina, etcetera. These are best practices that have been put in place that these states have already done a significant job of analyzing people, equipment, facilities. Those are the kind of best practices we would extend to communities that are still trying to find the answer to that problem.

The emergency management assistance compacts between states also offers us ways for hospital care, not so much emergency department evaluation but for hospital care. There are good models out there and best practices that we can share with communities.

REP. CAPPS: Thank you. And Mr. Chairman, I would hope that we could keep this discussion going as the days go in case there's a way that we should be responsive to you as well.

And now another challenge, Dr. Schuchat, for the provider in the household. You are calling on people to stay home if they are ill to prevent the threat of the H1N1 flu. But millions of people work every day but don't have any sick leave, don't have any time that they can take, and with this economic uncertainty they are very reluctant to stay home from work, and may go to work with symptoms or have to send their kids to school because there's no one to stay at home. This is going to be difficult to contain the flu. We do have legislation in the works. Senator Kennedy and Congresswoman DeLauro are planning to reintroduce the Healthy Families Act. I'm cosponsoring it. And that would guarantee seven sick days a year.

First of all, you could help us with support of that kind of legislation for the next event, and maybe if you have any thoughts of what you or we could do together to respond to this crisis?

DR. SCHUCHAT: Just a few comments. Health in the workplace and health in the family is very important. It's a central component of public health. And we did see during the SARS epidemic that in Canada some of the hospitals were really taxed trying to figure out how to make sure that healthcare workers, including contract employees, would stay home, whether furloughs needed to be used. And it was a very difficult circumstance to make sure that health was taking a front seat and that the rules could be worked out. So we would just be supportive in making sure that health is addressed.

REP. CAPPS: Thank you. I have one final question. There's not a lot of time for it, and maybe some ongoing conversation about this. It's to any of you because workforce shortages are something that you are experiencing in every of your agencies, and of all of local and state public health facilities 11,000 public health workers are due to be laid off because of state budget cuts, attrition over the past year. This is exactly who you are depending on even as we speak for solutions. Do you recommend any suggestions for us to help you do this, or to recruit more, to implement anything?

DR. SHARFSTEIN: A month ago I was the local health officer in Baltimore, Maryland, working with Congressman Sarbanes and others. And I think your point is very well-taken that a lot of the things that are being planned at the federal level really depend on the state and local public health authorities to implement. The emergency use authorizations that we granted give a lot of, had a very clear role for state and locals in how they hand out medicines that may be important to people. Eventually if there's a vaccine that's going to be delivered to the public health infrastructure. And ensuring that that infrastructure is strong is extremely important. And I know it's very important to the administration.

REP. CAPPS: My time is up, but there is more to talk about. Thank you very much, Mr. Chairman.

REP. PALLONE: Thank you.

Mr. Blunt.

REP. BLUNT: Mr. Chairman, I have a couple questions here. One, I got an e-mail from my daughter late last night who lives in Kansas City, and it involves here. But even more importantly, just as importantly, it involves my grandchildren. I guess I ought to think about how I say that. And the e-mail from her is: "Confirmed case of swine flu in Kansas City." On a scale of 1 to 10 how concerned should we be? Anybody want to give an answer to that?

DR. SCHUCHAT: You know, people like your daughter are concerned, and so are we at CDC and so is the government. But we're taking aggressive steps to address the challenges, and we do feel that we have been exercising and planning for this kind of circumstance. There's lots of things everybody can do in the community, in the family, as well as in the schools and workplaces. And so I think that this is a serious situation, and we all really need to get ready for some uncertainty, to stay aware.

It's great that your daughter knows exactly what's going on where she is and that guidance from the local and state authorities will probably help her understand what's going on there and what the next steps are: if your grandchildren's school is closed, for instance, or really what are the plans.

REP. BLUNT: What about, it's called swine flu, but is there any concern about the food supply at all? I mean I think it's important to clarify that, and you may have already. But if you wouldn't mind repeating that for me?

DR. SCHUCHAT: Sure. There's no evidence that swine in the United States have this new virus. There is no evidence that eating pork or pork products gives you this infection. The USDA is aggressively looking at the issue both here and working with Mexico as well. And I would say that we don't have any reason to believe that eating pork gives you this particular infection.

REP. BLUNT: And we have no reason to believe there's any other problem at any part of the U.S. food supply?

DR. SCHUCHAT: No. This isn't an infection that we think is food-borne.

DR. VANDERWAGEN: Our veterinarian colleagues over at Agriculture called this human flu because it doesn't occur, they don't see it in pigs, so they are calling it human flu.

REP. BLUNT: Do you think -- that's a good thing to understand because I think there is some reaction at the grocery store to what they think. The other question I have on Amy Blunt's scale of 1 to 10, assuming 10 is the most concern, it seemed to me that the vice president was there this morning at the 10 level when he said he'd advise people not to get on planes, his own family or even on subways. I'm sure that's not the official position of the government. Would somebody reiterate what must be a repetitive response to the official position of the government on that topic?

DR. SCHUCHAT: We've advised people to defer nonessential travel to Mexico. We've advised people who are ill with respiratory systems and fever to not go to work or school and not get on an airplane or a public transport. But we do not have recommendations to stay away from those transport methods if you don't have respiratory symptoms. And I'm looking forward to getting on an airplane later today to go back to Atlanta.

REP. BLUNT: Well, most of us will get on airplanes later today too and go back to Atlanta or Missouri, as I will, or other places. And I would hope that the commerce and the travel of the country don't shut down based on advice from the government. I yield back, Mr. Chairman.

REP. PALLONE: Thank you, Mr. Blunt. Mr. Weiner.

REP. WEINER: Thank you, Mr. Chairman. Let me just pick up on that a little bit. You know, I think you'll forgive our constituents for being a little whipsawed by the news and images that they get. And I represent the district that has half of all of the confirmed cases in the country. And you know, to watch some of the imagery on television, to listen to even official channels, to listen to the head of the health policy at the European Commission, in theory someone who's supposed to be pretty level-headed, it's not a question of whether people die, but more a question of how many. Will it be hundreds, thousands or tens of thousands?

You know, you'll forgive some of my constituents for wanting to get into the fetal position and bathe in Purell after hearing things like that. And let me say that it is in contrast to the way you all have presented yourselves. And so too with the health officials in New York City who I think have made a more sober assessment.

But just to put a finer point on the question Mr. Blunt asked, focusing on subways, just to instruct New Yorkers to avoid the subways is to in any case instruct them not to make a living, not to travel around their hometown. It is the very way that we communicate with one another and the way we get to and from.

If you are not one of the 96 confirmed cases, if you don't feel like you've got the flu, can you just say with clarity about subways, it is safe to get on a subway, we would encourage you to get on a subway? And if there was a subway to Atlanta you'd take it?

DR. SCHUCHAT: The only people we're saying should avoid crowded circumstances or airplanes for instance are people with fever and respiratory symptoms. We also think it's important for local authorities to be giving the guidance for the community. They understand the way the ground truth. And we know that the New York City Health Department is fantastic and really is providing good guidance.

REP. WEINER: Can I ask you, how good a job did the Mexicans do on letting you know what was going on? The report in today's Washington Post that lays out the tick-tock of notification that seems clear that the 24-hour rule was violated by a magnitude of a couple weeks. Apparently our Department of Health and Human Services which oversees the CDC found out about the Mexican outbreak about the same time the rest of us did, on television on the 24th.

It strikes me that that window of time is valuable, and it strikes me that in fact it could have helped -- well, maybe prevent some or at least have gotten us a couple weeks or a few days at least jump on this.

How would you grade the Mexican response up to now?

DR. SCHUCHAT: The Mexican community and government are coping with a very difficult circumstance right now, and the focus of our attention is providing technical support to help them respond to the situation. I can say that I don't have all the information, and I don't think anyone does yet, about all the circumstances leading up to where we are. But it's important to note that increases in respiratory illness happen quite frequently, and they can have lots of different explanations.

And as I understand it, the original increases that they were seeing were believed to be due to regular influenza. Most respiratory infections don't actually get a specific diagnosis, and we see lots of changes in the numbers that don't pan out to be anything quite serious.

Here in the U.S., because of our investments, we promptly recognize these very unusual strains of influenza and issued an MMWR dispatch after the first two that we had seen. But I think the circumstances in Mexico right now, the focus really needs to be on helping with the response.

REP. WEINER: Could I say, it is traditionally influenza outbreak happens in cold weather. And I know that there's some disagreement in the medical community about why that is. Maybe we're all together much more. Are we rooting for a particularly hot stretch here? Would that help us? Should we be trying to be out of doors more? I mean is the summer, the coming summer months, is it helpful to us, is it not clear that it's helpful? I mean if there's a high pollen count, does that mean that perhaps we should be more careful? Are there any weather- related indicators since this is kind of a counter-intuitive strain, it's hitting younger people more. Are there things about it that we have learned so far that gives us an indication that the weather might be on our side?

DR. SCHUCHAT: You know, we think from the past and from seasonal flu that we don't see much influenza in the summer months and so we hoped that will be the case. But every influenza expert that I hear from really cautions me in anything I say to remind people how unpredictable influenza can be and especially a new strain. So we do optimistically hope that things will get better because of the season. But we need to be attentive for the fall afterwards.

REP. WEINER: Thank you. Thank you, Mr. Chairman.

DR. VANDERWAGEN: I would just say that if we can get time, that really helps with the vaccine production. And the point about how each virus is different is extremely important about vaccine production. And I think just to clarify, I think the idea that a certain amount of vaccine will be ready in a certain amount of time, those predictions really can't be made now until we understand more about this particular vaccine, or this virus.

REP. PALLONE: Thank you. Next is the gentleman from Maryland, Mr. Sarbanes.

REP. SARBANES: Thank you, Mr. Chairman. First I want to say how impressed I am with the response that you and your staff has made to this situation. There's been a calmness and professionalism to it that I think is having a desired and appropriate effect on the public and I know that will continue. So thank you for that.

Also I want to echo those who are welcoming Dr. Sharfstein to his new position. As he indicated, we have worked together closely in Baltimore. We have suffered a great loss that he is now here, but the country is certainly gaining by his appointment.

Dr. Schuchat, you mentioned, and I was intrigued by this, that the number of cases is not something you're so much interested in as the patterns that you see emerging. And I wondered if you could describe a little bit more what you mean by that. What are the patterns that you're looking for, and what do those patterns tell you about the progress of this disease?

DR. SCHUCHAT: You know, we're working closely with some of the state and local public health officials who are on the front line of responding to this to really understand the epidemiology, who's more likely to become ill, what are the clinical characteristics of illness, how does it look like the infection is spreading, and how transmissible is it.

So those are things we're evaluating in some of the on-the-ground circumstances in the U.S. as well as with our Mexican and Canadian partners. Those types of investigations can help us understand what kinds of interventions will be most effective. We would love those investigations to show us that disease is becoming milder. But we need to be ready for the idea that the disease is becoming more severe.

So rather than focus too much on individual numbers, we know that numbers are going to be varying, that information is in flux, that we've just decided at the CDC once a day we'll update the numbers, and we're really focusing on the actions and activities.

And so the patterns are really at an early phase understanding where, which populations are at the greatest risk, how transmissible is the virus, and then the severity.

REP. SARBANES: Is it a combination of the patterns and the numbers that would also advise as to when a community ought to be taking a particular action shunning the schools and the community and so forth?

DR. SCHUCHAT: That's right. You know, we have guidance about when there's illness, confirmed illness in a school that we recommend that school be closed temporarily while things are being reevaluated. But there could be triggers that would prompt a more aggressive approach beyond that. There are other community interventions such as eliminating mass gatherings or really implementing social distancing, asking people to work from home and to really avoid crowds.

I was in Beijing during the SARS epidemic, and they intensively instituted those, and they really helped. But that was a very different circumstance. So I think the pattern will tell us whether more aggressive measures are needed.

We're really trying to strike a balance in making sure the interventions are not worse than the virus, because there's a balance in all of these interventions.

REP. SARBANES: Let me ask you a different question. There's been a lot of discussion and focus on sort of tracing back this virus to a specific geographic origin. Is that the right perspective to have, and is it the case that this disease will be appearing, as it were, spontaneously in a lot of number of different locations? Or does it make -- because when I hear people discuss they've found new cases, then the next question always is, did you have contact with somebody who recently traveled too? But that can't be the only dimension of the inquiry.



DR. SCHUCHAT: Yes, that's right. I think in the initial days there was an intense focus on contact with animals, and then a little bit after they were contact with Mexico. We are at a different point where there are lots of exposures that are being looked at. And really the intense look for cases is so that interventions around those cases and where they work or at school can be imposed.

So for those other sectors that are focusing on tracing back and where did that all start, that can be important information for future planning. But I think the public health community here in the United States is really focusing on what we can do to reduce illness and death and slow spread, giving time for more definitive interventions like vaccines. Should we go that route?

And really, really taking the focus of our goal is to reduce illness and slow transmission, not to find the source.

REP. SARBANES: Mr. Chairman, can I ask Dr. Sharfstein? It will be a 15-second question.


REP. SARBANES: Okay. I appreciate it. My understanding is that the flu strains we experienced this past winter did not respond particularly well to Tamiflu. Is that correct?


REP. SARBANES: Okay. But that we're seeing that at least initially this strain is responding. So I guess that's a lucky thing in a sense, right, because it could very well be that this strain also would not be responding. And so I'm just putting that in the happy coincidence category. Is that fair to do?

DR. SHARFSTEIN: Yes. But, you know, there are always a few qualifiers. We know, I think looking at it genetically and in the lab that it looks like there's activity against the virus. That doesn't necessarily mean that every patient as soon as they get it gets better. In fact it's more effective the earlier you get it in treatment. People who are quite ill, it can set up all sorts of problems in their body that even getting rid of the virus can't help anymore. So there's a qualifier there. The other qualifier is that it's possible that a resistance may emerge, and that's something that I know the CDC is very interested is, is watching very closely. That could have recommendations for treatment that could change, you know change recommendations for treatment. So we are starting off with a little bit of good news there, but it's going to depend on how the whole thing unfolds.

REP. SARBANES: Thank you. Thank you.

REP. PALLONE: Thank you. The gentleman from Iowa, Mr. Braley.

REP. BRALEY: Thank you, Mr. Chairman. I want to thank all the witnesses for being here. But Dr. Schuchat, I want to start with you and follow up on your answer to Mr. Blunt's question about the reality of this virus and its impact on our food supply. You said there's no evidence that swine in the United States have this virus, which is the standard answer on a CDC website in response to concerns about food safety issues. And if you go to the CDC website there's a specific question, Can people catch swine flu from eating pork? And the answer says there's no evidence that swine influenza can be transmitted through food.

And yet your website is the only website of all the organizations here including the WHO that continues to identify this as swine flu. And on the website it also makes reference to the fact that this is a new strain of flu that consists of a mixture of genetic material from swine, avian and human influenza viruses.

I come from a state that is a leading pork producer in this country and in the world, and this outcry over the alleged connection between food safety and this virus is having an enormous economic impact on pork producers in Iowa, North Carolina, and all over this country. So is there a plan to change the website and refer to this by its appropriate scientific name "Influenza A, substrain H1N1?"

DR. SCHUCHAT: Our new information will have the new terminology. Our communication team are focusing on critical information for healthcare providers, for families, and so forth. And so we do intend to make sure that the many, many thousands of website pages that we have already put up in the past week become amended. But the critical focus of the people in place right now is developing the new information that people need.

So we understand the concerns and are very mindful in our communication going forward, and really need to -- people are working 24 hours a day. There are communication experts in there. It's really, I don't want to be impolite, but I want to just say that our priorities are the public health information being out there quickly and accurately and going forward we will do the best that we can.

REP. BRALEY: And I appreciate that. No one appreciates that more than I do. But I'm also concerned because I was at the congressional briefing yesterday, and when you go to the CDC's website what you find is a page, the first page that says "Swine Influenza." And on that page there are probably at least 10 references to swine influenza. And when your agency is one of the most critical public information dispensers in the federal government, it feeds this misperception if you don't address this issue immediately.

My point is that these other agencies are not using that terminology, and it's for a reason. So I would just encourage you, knowing that you are not in charge of the communications division at CDC, to emphasize to them the importance of making that change as quickly as possible. Would you agree to do that?

DR. SCHUCHAT: We will do the best that we can.

REP. BRALEY: Now, one of the other concerns I have is the impact on workplace safety because one of the things that OSHA has done is prepared a handbook, Guidance on Preparing Workplaces for an Influenza Pandemic." Have any of the three of you had an opportunity to review that pamphlet to determine whether it consists of the most up-to-date information to help prepare workplace environments to deal with a potential influenza pandemic?

Dr. Sharfstein?

DR. SHARFSTEIN: I haven't personally looked at it, but we have an employee health part of our team on personal protective equipment. And I know they have been talking to OSHA. So the FDA part that oversees the devices, because that's really what it is, the mask and that sort of thing, relates directly to OSHA. And I know that our team and the OSHA have been talking about the different authorizations the FDA has made, how that intersects with what OSHA needs to do to protect workers.

DR. VANDERWAGEN: Mr. Braley, I think most of the elements of HHS have worked closely with OSHA. Most specifically NIOSH, National Institutes of Occupational Safety and Health, which is part of the CDC, has been working extremely closely with OSHA to assure we're aligning any health guidance that we're bringing forward out of our department, it's accounted for in their documents. We've worked very closely with them on masks, we've worked very closely with them on a variety of things over the last two or three years. So I think we're lashed up pretty good with the OSHA folks, vis a vis assuring that we have a common message and a common set of principles.

REP. BRALEY: Right. Thank you.

REP. PALLONE: Thank you. Next is the gentlewoman from Wisconsin, Ms. Baldwin.

REP. TAMMY BALDWIN (D-WI): Thank you, Mr. Chairman. Thank you to our panel of witnesses today. I want to join in the sentiments that have been expressed by some of my colleagues about the very good job that has been done identifying and tracking this outbreak and the communications to the Congress as we are trying to learn more and work hand in hand with you and your mission.

I think an outbreak like this exposes the strengths and weaknesses in our public health system. Dr. Vanderwagen, you talked about the system as sort of people supplies, equipment, facilities, and systems. And I have been working with a number of my colleagues on both sides of the aisle on trying to address our public health system and strengthen it in some areas where I think that there are some weaknesses.

I want to probe into two of those areas. One is relating to our state labs of hygiene. I guess I'd start with you, Dr. Schuchat.

And would like to hear your feedback on how it is these days working with the states to track and monitor this disease?

And I ask the question because, in my examination of the issue -- and this is based on a 2007 survey by the Council of State and Territorial Epidemiologists showing that 16 states are still completely paper-based, 20 states are still using manual reporting that's web-based, and only two state public health laboratories in the country have bi-directional data flow that can both send and receive laboratory messages.

I understand also that technology is not yet deployed that would support new pathogen discovery, and rapid electronic exchange of public health information, national bacterial and viral databases for DNA fingerprinting of infectious disease organisms, things like that. If you could tell me how things are going, and how those technological upgrades being deployed in our labs might help?

DR. SCHUCHAT: You know, the promise of information technology is huge and, unfortunately, it hasn't gotten applied to public health infrastructure as rapidly as in some of the business community. And I think we are not where we would like to be in that area.

You know, during this investigation, we've just yesterday, I think, got electronic reporting from the states coming in, which was exciting for us because it's been a long time coming. But, that's just for this investigation, not for everything. You know, there are huge opportunities in that to really increase the efficiency of how public health works.

MR. VANDERWAGEN: And, ma'am, I would -- the comments I made to the member from California apply here as well, that as we think about health reform, and we think about preparedness, it's not just a matter of hospital services concerned here. I think these issues are going to need to be thought through as part of that context as well.

REP. BALDWIN: Yeah, let me follow up with some of the personnel challenges we're dealing with. Certainly, as states and local governments have real budget squeezes -- I know that they've had to shift around staff in order to deal with this outbreak -- I don't have a specific question right now on the staffing of labs of public hygiene.

As I said, I'm working on bipartisan legislation. We've introduced a bill called "Strengthening America's Public Health Systems Act," which deals with the technology and the personnel there.

But, I want to focus quickly on another area of personnel or workforce shortage, both present and looming, and that's with regard to public health veterinarians. While we have probably -- I want to say, about 85,000 veterinarians in the nation, I think my figures say only a little over 4,000 are food-animal predominant, some with a mixed practice -- the number of veterans (sic) in public, corporate or federal positions, which includes teaching, research, military, inspection and food safety, is just under 15,000. And the projections are that we will have a significant increase in demand, as we move forward, for these professionals, and a significant shortfall now, and as we move forward.

Dr. Vanderwagen, can you talk to us a little bit about the role of public health veterinarians with regard to this outbreak? And are you seeing that the shortage of public health veterinarians in the U.S. and around the world is having an impact now?

MR. VANDERWAGEN: Yes, ma'am. And you read my eyes. My dad was the chief veterinarian for the State of California, and so I grew up in a home with a public health veterinarian, large-animal practitioner to start.

I think it's critically important that we think in terms of one medicine. There are many more species with health issues than humans. And even though we focus heavily on humans -- and I think appropriately so, it's our species -- notwithstanding that, we are at extreme risk for a variety of diseases that emerge from the animal environment. And, without the kind of knowledge that public health veterinarians bring, with regards to animal-based diseases that have zoonotic -- that is, transmissibility from animals to humans as an underlying principle, we end up flying blind on a significant number of challenges that our health security may be confronting.

So, I think it's critically important that we think about that workforce, and that we embrace the notion that there's more to health than simply that of humans alone.

REP. PALLONE: Thank you.

The gentlewoman from the Virgin Islands, Ms. Christensen.

DEL. DONNA CHRISTENSEN (D-VI): Thank you, Mr. Chairman.

Dr. (sic) Vanderwagen, you can't get away from me -- you noticed, right? (Laughs.) Okay.

I'll start, my first question is to Dr. Sharfstein. On the Flu Panel Diagnostic Test, are those available to the Territories, like my own, and those in the Caribbean, and those in the Pacific? Do we have the assurance that we have the availability of those tests?

DR. SHARFSTEIN: Sure. I'm actually going to -- as Dr. Schuchat said, FDA made them available to the groups that -- of labs that CDC requested --


DR. SHARFSTEIN: -- which is this network, and.

DR. SCHUCHAT: Yes, I was just trying to verify. We have been shipping the test kits to public health laboratories that are either part of the Laboratory Response Network, or similar public health labs. And so I don't actually know. I believe it's likely, but I will need to check, and we can get you that information.

The idea is that the public health laboratories be able to -- that have gone through the appropriate training and are part of this system, be able to perform these tests.

DEL. CHRISTENSEN: I would suspect that ours is in Puerto Rico. But, the Pacific, it is much more difficult.

DR. SCHUCHAT: Absolutely, yeah.

DEL. CHRISTENSEN: And they shouldn't have to go all the way to Hawaii, is one my concern.

Would you pronounce your name for me?

DR. SCHUCHAT: "Shook-it."

DEL. CHRISTENSEN: " Shook-it," okay.

So, Dr. Schuchat and Dr. (sic) Vanderwagen -- and you know this already, but all during my time on the committee on Homeland Security I have been concerned about the inequities and the deficiencies in the public health system in certain parts of our country -- communities that are rural, Indian reservations, poor communities, communities of color. And they're very vulnerable, and it's often said that when the rest of America gets a cold, we get pneumonia.

So, my question is: Knowing this, what special efforts are being made to ensure that these communities have what they need, given that their infrastructure -- the poor health infrastructure, in terms of hospitals have closed, less labs, less providers, what is being done to reach to these vulnerable communities?

DR. SCHUCHAT: You know, this is a huge issue in health in general.


DR. SCHUCHAT: In terms of the new influenza virus investigation and response, one of the teams that we've stood up is a Vulnerable Populations Team that's really trying to address the appropriate outreach and planning for communities that may be harder hit.

MR. VANDERWAGEN: Well, and Ms. Christensen, it's so good to see you again, really, because I think we have a great dialogue that's important.

With regards to the Indian country -- because you know that's --

DEL. CHRISTENSEN: Yes. And I see your watch and your ring --


DEL. CHRISTENSEN: -- and I -- (laughs).

MR. VANDERWAGEN: With regards to the Indian country, at least for those Indian people that are provided service -- funded, or directly provided by Indian Health Service, they're on our daily policy calls; they're on our ESFA calls on a daily basis, so that the most recent and clear communication can be transmitted through that system to people who are dependent on those health systems.

The tribal leaders are actually here in town today to talk to HHS about budgetary considerations and concerns, and we will listen and respond the best we can.

DEL. CHRISTENSEN: Thanks. Great.

And Dr. Schuchat and Dr. Sharfstein, you said that this virus is a new virus, but it has genetic material from four known viruses (of) various origins. What, if anything, does this mean in terms of the severity of the illness; what you would predict -- a possible level of prior immunity in the development of the vaccine? Do those four pieces of genetic material make any difference -- making it any easier to deal with?

DR. SCHUCHAT: The virus is new and we don't -- although it's H1N1, it's different from the human H1N1s that are part of seasonal flu, that many of us have been exposed to or have been vaccinated against with the seasonal flu vaccine.

We can't predict with certainty what this virus will do. So, the four components only tells us --

DEL. CHRISTENSEN: Don't help? They don't help?.

DR. SCHUCHAT: -- (inaudible) -- doesn't just -- it just tells us it's new. There's a possibility there might be some cross protection in certain subpopulations, and it's the kind of thing we're looking into. But it's -- you know, since we've tested many, many thousands of strains, and never seen it, it's novelty that's the most concern.

DR. SHARFSTEIN: And I agree completely. And the only thing I would add is, the question has been raised whether people who got the flu vaccine this year have any extra protection against this. And I don't think that question has fully been answered. It's one of the things that the CDC is looking into.

The initial tests, which test one type of immunity, did not show any cross reactivity. But, there -- there's the potential there, and I think that's going to be an important question to answer about it.

I think, in general, the answer is: You can understand what the virus is, but to understand how it behaves you just have to watch how it behaves. It's just hard to determine that just from the genes alone.

DEL. CHRISTENSEN: Okay. Well, my time is up. Thank you.

Thank you.

REP. PALLONE: Thank you.

The gentlewoman from Illinois, Ms. Schakowsky.

REP. JAN SCHAKOWSKY (D-IL): Thank you, Mr. Chairman.

I want to add to the chorus of thanks. I think that the response has been really comprehensive. And we have on our website now a link to yours, so that people can get the best and the latest information. And I think a lot of members are doing that right now.

We now have in Illinois nine, 10, 19 suspected cases is it -- 17 probable cases in Illinois. The one school that was closed in Illinois is in my district at the Kilmer School. I don't know if any of those have been confirmed. Do you know that? Anybody know?

DR. SCHUCHAT: No, I don't have the details of that. And I certainly feel for the folks in that -- in your district who are coping with such a challenge.


I wanted to -- I wanted to ask you about, if and when we have immunizations and vaccinations for -- if not immunization, but vaccinations, most states' Medicaid programs provide some coverage for adult beneficiaries in situations like this. And some states have exempted some populations from a nominal co-pay -- pregnant women, children. I realize that this is impacting a somewhat different population.

Do you think that, in certain public health problems like the current one, it would be good policy to exempt all Medicaid beneficiaries from cost-sharing for vaccines, and maybe for other things as well that are related to this outbreak? And I'm just wondering how that might impact the numbers of people who are able to access the care that they need.

MR. VANDERWAGEN: Yeah, I think -- and I can't answer you definitively, ma'am, but I would suggest that the considerations are that, when we have this kind of an issue, it's about our population and our citizens as a whole, and less about individual benefits and services. We need to think about what can and should we do to serve our whole population.

That's a little different mode than the way we think about medical care and health services in the country, generally -- which is about care for that one-on-one patient. Here, we have to assure that our whole population is protected in the face of a challenge.

Does that mean we should promote a waive policy? That's for people above my pay grade. But, I think there's a -- there is a real public health argument that says we have to think about population, and not just think in terms of limited individual benefits -- which would suggest that we should cover everyone --


MR. VANDERWAGEN: -- for those threats.

REP. SCHAKOWSKY: Individuals, however, when seeking care, think about their own situation -- and whether or not they're covered, and whether or not they should be going to the doctor, and whether they can afford to go to doctor.

And so I think we have to think about how we convey that "people who may have it should seek the care that they need."

DR. SCHUCHAT: Yeah, and we don't -- you know, it's important in this kind of circumstance to eliminate the barriers to people presenting, who need to be either cared for or for whom interventions would need to be initiated.

It's been a challenge in a lot of infectious disease outbreaks, where communities sort of go underground and don't want to -- you know, are fearful about presenting for care, or the ability to pay. So, it's very difficult with infectious diseases which don't respect, you know, what insurance card you have --


DR. SCHUCHAT: -- and I think we really want to have a public health approach that will help the communities.

MR. VANDERWAGEN: What she said.

REP. SCHAKOWSKY: (Laughs.) Okay.

Let me ask another question. I wonder if someone can describe the process for data-sharing between Mexico and the United States. My understanding is that we have a number of unanswered questions: Whether Mexico's in the first or second wave of the illness; the percentage of people dying from the flu, compared to the percentage of people who are infected; et cetera.

DR. SCHUCHAT: You know, I'm happy to say that we -- the CDC is part of a tri-national team that is on the ground in Mexico -- Mexicans, U.S. workers and Canadians, who are working on the epidemiology and laboratory aspects of investigating and responding to this concern.

Information is getting better now, but information in this kind of outbreak is really difficult even in the best of circumstances. Information can be sketchy at the beginning, and we need to hone in on the details. And, in particular, before you have a good laboratory test it's hard to tell what's going on with people with pneumonia or severe respiratory illness.

And so one of the goals of the tri-national team is to strengthen the laboratory capacity in Mexico so they can detect this new strain right there, without having to ship to the U.S. or Canada or elsewhere. So, I think we are getting much better information and cooperation -- I mean, the cooperation has been good, but the information quality is improving by the day.


DR. SHARFSTEIN: I could just add that FDA is collaborating with the FDA-equivalent in Mexico around some of the recommendations that have been made in the United States that would be applicable, like what the right dose is for young children.


REP. PALLONE: Thank you.

Ms. Eshoo.

REP. ANNA ESHOO (D-CA): Mr. Chairman, thank you for having such a timely hearing on such an important subject.

I have so many things that I want to say and ask, but. This is my -- these are -- first of all, thank you for the magnificent work you do in each one of your agencies. I think they're all parts of the -- jewels in the crown of America's health system, that needs help in so many ways, but, boy, do we depend on the work that's done out of these agencies.

Here's my sensibility: That people are being -- and it may have been said earlier by members when I wasn't here, when the hearing began -- the American people are inundated by the blaring, glaring headlines. And, as one of the staffers said behind me, that the only break that they had from swine flu was that Senator Specter is switching parties -- that was the news break, and now we're back to swine flu.

I'm not diminishing what all of this represents, the seriousness of it, but I think that what people need to hear, over and over again, are the really commonsense steps of responsibility that they need to exercise -- washing our hands a thousand times a day; the coughing the sneezing, making sure that we cover our faces.

I think, on this issue of air travel in the United States, I'm pretty sensitive about this. I've commuted across the country now every single weekend for 16-and-a-half years. And, as my mother would say, I don't know who has raised some people but they don't cover their faces when they sneeze or they cough.

Now, this is voluntary for the airlines to say something, but if they can remind everyone to fasten their seat belts, in the eventuality that something can happen to us if there's a drop, I think that that should be part of the text; and that our government ask in very strong, firm tones -- we don't need to pass a law on this, but I think the director, or the secretary of Transportation, along with health officials, should get on the phone and have a conference call with all of the airlines and say, "Please, we are asking you to make this public health announcement at the beginning of every flight."

Because the proximity of human beings, one to another, on a plane is far different. Now, I've been told that -- in walking down the hall, one of the House doctors was telling me that if someone coughs or sneezes, it's six feet. I sit pretty close to people on the plane. So do all of you. So, I would ask that you do that. Get that ball rolling. And I think that that's, in terms of prevention, really important.

I wanted to ask the following,: And that is, in the 109th Congress, Representative Rogers of Michigan and myself introduced legislation, and we were successful in -- because it became law, it was the Biodefense and Pandemic Drug Development Act, called BARDA, to create -- you're all nodding -- a new office within HHS.

What's the nexus between that office -- the work that it's done, and this swine flu, that evidently really doesn't come from pigs?

MR. VANDERWAGEN: Ma'am, I'll answer that fairly simply. I mean, BARDA has always worked across the department to assure that the NIH discovery research and the FDA oversight responsibilities get brought into the mix as we do advanced development.

Over the last four years what has happened is that BARDA, through their funding, brought us the first licensed H5N1 vaccine. They brought about the kind of vaccine production changes that Dr. Sharfstein referred to, where we have a "warm base,"if you will --

REP. ESHOO: Oh, that's very good news.

MR. VANDERWAGEN: -- that would allow us to ramp-up --

(Cross talk.)

REP. ESHOO: That's very good news.

Well, the good news was that the House did, in our economic recovery package, included increased funds for this. But, the Senate took them out.

I don't think they're going to be feeling so good about that right now, with what's going on. Maybe one of them is tuned into this hearing tonight when they're home sitting on their sofa.

So, let me ask this question, oh, I just have -- I got four seconds left, can you explain how the CDC and the federal government plan to administer a flu vaccine? And given that many of those who -- so far, from what I've read, that are infected are children, is this going to be performed in schools? And will it be a mandatory vaccine?

DR. SCHUCHAT: There are answers --

REP. ESHOO: Maybe those -- (inaudible) --

DR. SCHUCHAT: -- yeah, there's the answer to only some of those questions. But, the states have been planning around counter-measure response assessments, and they've done exercise drills with seasonal flu vaccine, in terms of how will they administer promptly; get the kind of information --

REP. ESHOO: Well, they're going to -- you're saying they'll probably use that same model?

DR. SCHUCHAT: Correct. And they're also making sure they have ways to find out who's gotten one dose, because there's a good chance they'll need two doses of this. So, there are, you know, state-based planning efforts around those models.


Well, again, Mr. Chairman, this is a timely hearing. I thank all of you -- the great professionals, health professionals, professionals of our country. And we've learned a lot today.

And I think we really have to be very sensible about this, as the science and the science -- scientists and the medical community takes the lead. But, we just have to hammer home what people can do to be responsible, all day long, every day. And I think that's going to equip them with a sense of -- a little, some sense of reassurance on this. Thank you.

REP. PALLONE: Thank you, Ms. Eshoo.

The gentlewoman from Ohio, Ms. Sutton.

REP. BETTY SUTTON (D-OH): Thank you, Mr. Chairman.

And thank you very much for your testimony, and, even more importantly, for what you're doing to try and deal with this situation and keep our -- keep the public safe.

I come from Ohio. We have one confirmed case, and it's in my district. The case arises in a child who traveled with his family to Mexico. And the situation -- over spring break -- and the situation is that the school has been closed. And I know that the CDC, Dr. Schuchat, recommends -- the language I see here "recommends strong consideration of school, closure of schools with a confirmed case or a suspected case that has been epidemiologically linked to a confirmed case."

The first question I have is, why do you stop short of saying, "close the school?"

DR. SCHUCHAT: You know, I do think that we are evolving our guidance over time, and some things may because clearer or stronger over time. At the time of the initial drafting of guidance there was quite a bit of debate, because illness that we had been seeing was fairly mild, and there was a question of balance.

I think it's really -- I think it's in there, but we meant to have in the guidance information about the local authorities having the best information, or respecting their ability to make decisions that were either more stringent or less stringent that ours.

But, I do think, at this point, we think it's very prudent to close schools where a case has been confirmed, or is highly suspect, until we have more time to understand what's going on. So, we are probably a little bit more aggressive than when that was written.


And, to a follow-up, I should say that the superintendent in the school district did close the school. So, I commend him strongly for doing that.

This is a case that, as I say, a child traveling with their family -- there are other siblings who go to other schools, who are not, you know, exhibiting the symptoms of the swine flu. What is the recommendation there, on that situation?

DR. SCHUCHAT: -- (inaudible) -- at the present time, what we've suggested is that the intervention be targeted at the school where the child with illness is -- additionally, that gatherings associated with that facility be closed; but recognizing that there's a lot of variation in local realities -- a school district in New York City is very different than a school district in a small town; and really respecting the ability of the local authorities to assess a situation, and the practicality -- the issues of what's possible.

We really want to make sure that our interventions are not having more adverse impact than the virus itself. But, we also are being mindful that we don't know as much as we want to know, so far, about this particular virus, and we're probably being more aggressive than others would think we should be in order to protect people.

REP. SUTTON: And isn't it correct that, unless a person is exhibiting the symptoms themselves, they aren't -- you know, that the danger of transmission is not present?

DR. SCHUCHAT: You know, unfortunately, there are no absolutes. And what we think about from seasonal flu is that you may be able to spread infection the day before you have symptoms yourself.

And so, you know, it's one of those circumstances where we wish it were simple; and we wish there was a very specific symptom; and we wish that everyone who is infectious knows they're infectious and can stop from spreading to others. But, we're at early days with this virus. It's a new one. And we don't know whether it will be most infectious later on in illness, or what.

With the SARS epidemic we were really fortunate, actually, that most of the spread occurred when people were really, really sick, not in those early days. But, when you have infections that are transmissible before they're symptomatic -- before a person is symptomatic, those are really tricky.

And that's the case with measles, in fact. People think that "if I don't vaccinate my child, it's okay;" and "my child can't spread the infection to somebody else;" "I'll know when they're sick and keep them home." But, you can actually spread measles before you even know you have it.

So, this is just one of those challenges with infectious diseases and why we're being pretty aggressive in our interventions now.


And if I could -- this goes back to a lot of what we've heard here about common sense -- about, you know, people staying home when they're sick, and the like. But, you know, the people I represent are hardworking people and they're not -- they don't stay at home with a sneeze, because you just, you know, it's very difficult.

But, could you just explain and stress the importance of people who aren't feeling well staying home, their kids staying home; and, frankly, you know, the implications to employers too, and why it's to their benefit that, obviously, those folks stay home?

DR. SCHUCHAT: Some of the interventions that we're recommending are inconvenient. We actually did an effort, in our planning a couple years ago, to address the public. We did public engagement in several communities to understand what people, average citizens were willing to do if there were risks of something like a pandemic happening -- what was the trade-off, in terms of personal flexibilities, and then the social protections?

And through that we learned that there was support for many more aspects, I think, of this community mitigation strategy than I think some of us would have expected. But, there's a balance, and we'd really like to understand, what is the severity, what is likely to be happening, before we really reduce people's lives, you know.

REP. SUTTON: Thank you. Appreciate it.

REP. PALLONE: Thank you.

This completes our questioning. But, I just really want to thank you again for being here. I thought it was very helpful to us.

You know, you heard several members say that they'd like you to keep in touch with us. Certainly, I'll express that as well. Hopefully, things do not, you know, really get to the pandemic stage, but obviously if -- we might at some point ask you to come back again. I hope that's not necessary.

We also have a policy where -- probably within the next 10 days you could get additional questions from members to answer in writing, and so we'd appreciate a response.

But, again, thank you very much, and God speed in what you're doing. And, without further objection, the subcommittee hearing is adjourned. Thank you. (Sounds gavel.)

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