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Public Statements

Prescription Drug User Fee Amendments Of 2007

Floor Speech

Location: Washington, DC



Mr. KENNEDY. Madam President, we will see later this morning the successful conclusion of this legislation. We have some important matters to consider, which we will do in a very short period of time. But as we are coming into the closing time for this amendment, I think it is appropriate that we review very quickly what this legislation does and what it does not do.

I am a strong believer in this legislation, which has strong bipartisan support. I am enormously grateful to Senator Enzi and Members on our side of the aisle as well as those on the other side for all of their help and assistance in getting us to the point where we are ready to take final action on something that makes a major difference to families in America. We ensure the safety of our prescription drug system and also are making very important progress in the safety of our food supply.

This is, in an important way, breakthrough legislation. I will review quickly what this does and then come back to the amendments that are before the Senate and how we think the Senate should dispose of them; why this legislation is urgent, why it is extremely important, and why the American people deserve the best.

Very quickly, again, there is strong emphasis on safer food and safer medicines for families in this country. We spelled out at the earlier part of our presentations the effective systems we have supported to make sure we are going to have the safest prescription drug program in the world, using different kinds of modern technologies and also modern surveillance systems for monitoring postmarketing safety. This will ensure in the future we are going to have the safest prescription drug program in the world. We will have safer medicines.

We will also have safer food for families and pets. I think all Americans have been alarmed, as they should have been, by what has been reported in the news in the last few weeks. Many families have lost their pets because the agency lacked the

authorities provided in this bill.

We will have earlier warnings on drug safety problems using extremely elaborate systems of postmarketing surveillance. These systems will use both public and private centers to collect information that the FDA will use to find early warnings of possible harm. In these cases, the agency will be able to take expeditious action. That has never been done before.

We are going to have better medicines for children. We are enormously appreciative of the excellent work that has been done by Senator Dodd and Senator Clinton. This was done in a bipartisan way with Senator DeWine, who is not here. We all realize that children are not little people; children are children, and therefore their bodies react differently to various kinds of prescription drugs. This legislation provides mechanisms to get information on safe and effective use of medications in children as well as to promote studies of drugs in pediatric populations. In the past few years, we have made enormous progress and we believe this legislation will help to an even greater extent.

We are going to have more transparency and stronger science at the FDA because of the wonderful work done by Senator Mikulski. She and others worked to assure that we have greater awareness by the public of what is happening at the agency.

There is greater focus and attention on making sure the agency is going to have the best in terms of the new sciences. We are in the life science century at the present time. This has been impressed on the country with the extraordinary convention on biosciences that took place in Boston in the last few days. There I listened and read about the potential the life sciences have, not only in terms of energy and agriculture but also in terms of medicines. The United States is absolutely poised to continue to be the world leader in these fields, with all of its implications of healthier families here and around the world.

We need to make sure we are going to have the best kind of science at the FDA. We do that in the way we have given greater authority over the development of the science function at FDA. We also provided a rather unique foundation that will be able to use public and private funding. This foundation will seek out the best and the newest modalities to help speed the review of various prescription drugs. That is going to be enormously important because time means cost. If we are able to resolve these issues more quickly the costs will be more understandable and reasonable to consumers and we will get them faster.

Briefly to comment on some of the amendments, we have taken a position in our proposal that both the safety and efficacy of particular prescription drugs is a function that ought to be considered in tandem. I know there are those who think we ought to separate those functions. We can imagine a circumstance, for example, where the side reaction of a particular drug is that individuals lose all of their hair and they become nauseated. Clearly I am describing the impact of methotrexate. That can happen to an individual on many anticancer drugs. You wouldn't prescribe that for athlete's foot because the side effects are so dramatic, but you would approve that for another kind of regime to try to treat cancer.

We also have items on civil penalties for the first time. There is a question of what those civil penalties should be. I want them to be higher, but I am mindful as well that this is the first time we are going to have those civil penalties. We are going to be working on those matters with the House. I basically think they should be a little higher, but I listened to my colleague on this issue and we are going to try to make sure we get something that is going to be fair and can do the job.

I am also mindful of the concern we have in terms of the potential of conflicts of interest. I will reserve my time to be able to deal with this issue.

This is a very important issue. We want to make sure, on the one hand, as we have these breakthroughs in science, that we are going to have the best experts participating in these review groups. We also have to be sensitive to the issues of conflicts of interests. I know the Senator from Illinois has a proposal on this.

I will reserve the rest of my time to be able to discuss that later.


Mr. KENNEDY. Madam President, I would like to take some time to talk about some issues that I haven't spent a great deal of time describing to the Senate about S. 1082, the Food and Drug Administration Revitalization Act.

First, I thank Senator Roberts and Senator Harkin for working with Senator Enzi and me and with many members of the committee on the important issue of direct-to-consumer, or DTC, advertising.

We have worked together to accomplish our common goal--a constitutionally sound, effective, workable way to see that DTC ads provide accurate information to patients about the drugs they are taking.

Some have advocated a ban on such advertising altogether, but Senator Enzi and I rejected that approach since it failed to meet the constitutional test. Instead, we included a more measured provision in our legislation that allows FDA to impose a moratorium in extraordinary circumstances where needed to protect public health.

During our committee's consideration of this issue, Senator Roberts brought up his concerns that even this limited provision fell afoul of recent Supreme Court decisions on free speech. Senator Harkin raised his strong interest in seeing that these DTC ads include strong, effective safety information that is clearly and prominently presented to consumers in a way that does not gloss over important information. Senator Enzi and I committed to work with Senator Roberts to see that any provision on DTC met the constitutional threshold, and we agreed to work with Senator Harkin to make certain that it provided strong safety information to consumers. The result of our discussions is an amendment that our two colleagues offered. It is a true bipartisan compromise, worked out by two Senators committed to making real progress on an important issue, and I am pleased to support the amendment.

Instead of the moratorium included in our original bill, the Roberts-Harkin amendment puts in place strong safety disclosures for DTC ads, coupled with effective enforcement. Under current law, safety disclosures can be an afterthought--a rushed disclaimer read by an announcer at the conclusion of a TV ad while distracting images help gloss over the important information provided. Our proposal requires safety announcements to be presented in a manner that is clear and conspicuous without distracting imagery.

We also give FDA the authority to require safety disclosures in DTC ads if the risk profile of the drug requires them. Senator Roberts had a concern that this authority not be used indiscriminately, so we have made clear that the required disclosure must pertain to a specific identified risk.

We have made important improvements in FDA's ability to enforce the requirement to provide clear and accurate information to consumers.

For advertisements, as in so many other areas, FDA's enforcement tools are now limited. Although FDA does have the capacity under current law to remove a drug from the market for misleading ads, that authority is not often used and rightly so, since it punishes patients for the transgressions of the manufacturers. Since removing a drug from the market is an empty threat, FDA is often left with little option but to make polite requests to companies to change their ads. Under the Roberts-Harkin amendment, FDA will have the ability to levy fines of up to $150,000 for false or misleading ads.

It is unacceptable for patients to be put at risk by inaccurate ads. The Roberts-Harkin amendment makes certain that FDA will have the ability to see that this does not occur, in a way that is clearly consistent with the Constitution.

The amendment is a victory for bipartisan common sense on a difficult issue.

I would also like to address the affect of title II of this bill. Generally speaking, title II grants the FDA new authority to conduct postapproval safety surveillance activity in order to improve drug safety.

In enacting title II, we do not intend to alter existing State law duties imposed on the holder of an approved drug application to obtain and disclose information regarding drug safety hazards either before or after the drug receives FDA approval or labeling. Nor are we expressing a belief that the regulatory scheme embodied in the bill is comprehensive enough to preempt the field or every aspect of State law. FDA's approved label has always been understood to be the minimum requirement necessary for approval. In providing the FDA with new tools and enhanced authority to determine drug safety, we do not intend to convert this minimum requirement into a maximum.

As the Institute of Medicine and others have found, the FDA's past performance has been inadequate. While we fully expect substantial improvement as a result of the enactment of this bill, we cannot and do not expect the FDA or this new process to identify every drug-specific safety concern before a drug manufacturer becomes aware or should have become aware of such concerns. Nor are the bill's requirements that holders disclose certain safety information to the Government intended to substitute for the disclosure requirements that may be required under State law.

I would also like to focus on another aspect of our legislation, the Reagan-Udall Foundation.

During the discussions that led to consideration of this bill, we heard time and again that there was a major need for better research tools to aid FDA in evaluating the safety of drugs and help researchers move through the long process of developing drugs more effectively. Every day that a new medicine is needlessly delayed is another day that a patient does not receive a treatment that could well mean the difference between health and continued illness. If new research tools and better ways to evaluate the safety and effectiveness of drugs could be developed, patients will benefit from quicker drug development. If current procedures can be made more effective, then the cost of developing new drugs will drop.

One area where scientists can make real progress is developing new cell lines and new genetic techniques for testing drugs that reduce the need for costly forms of testing.

The Reagan-Udall Foundation sets up a way to develop these new tools--not so they can help just one researcher or one company, but so they can help the entire research enterprise. New ways to test drugs for effectiveness and safety will bring new advances to patients quicker and more smoothly. Through the Reagan-Udall Foundation, they will be available to the FDA and to the entire research enterprise. This new foundation is not many pages in a long bill, but it is an important component to help get needed medicines to patients as quickly as safety will allow.

I also wish to mention another critical aspect of our legislation--its registry of clinical trials.

This provision serves two essential purposes. First, it allows patients who want to enroll in those trials an accessible and central Internet site to find out which trials are being conducted and whether they might be eligible.

This provision builds on an existing provision of law to create a clinical trials site, but report after report has shown that the requirement to list trials has not been complied with. Our legislation puts more force in the requirement to list trials so that patients will benefit.

Listing trials is important for patient access--but reporting results is critical for safety. Our legislation requires that the results of trials be reported. No longer will companies be able to hide the outcome of a trial that did not turn out the way they hoped.

Examples of this kind of abuse are shocking. The manufacturer of the antidepressant drug Paxil conducted five clinical trials of the drug in adolescents and children, yet published only one study whose mixed results it deemed positive. The company sat on two major studies for up to 4 years, although the results of one were divulged by a whistleblower and all of the studies were submitted to the FDA when the company sought approval for new uses of Paxil. At that time it became apparent that Paxil was no more effective than a placebo in treating adolescent depression.

Under the bill, these kinds of abuses will not be permitted, since clinical trials will have to be reported--no matter what the result.

Senator Enzi, Senator Dodd and many others in the committee worked hard to get this provision right. We require immediate listing of all publicly available data and require a negotiated rulemaking, backed by the full authority of statute to develop the precise requirements for other results information to be included.

I would like to thank my colleagues for considering these comments as they relate to S. 1082, and I urge my colleagues to support the bill.


Mr. KENNEDY. Madam President, I commend my colleague from Illinois and my colleague from New Mexico for their amendment on the conflicts of interest and for working with us to address these issues in appropriations bills during the past year.

Their amendment includes many thoughtful proposals I support: including the right to call for the FDA to improve its outreach to experts who have no conflicts of interest and their right to call for greater transparency in the process of waivers.

But where I disagree with my friend from Illinois and New Mexico is that there should be an inflexible cap on the number of waivers for conflicts of interests an advisory committee can grant, no matter what the expertise of the scientists involved.

The amendment would impose a one-size-fits all, one waiver per conflict, per committee, relegating any additional members with conflicts to a secondary guest status on the committee.

The FDA has recently issued a policy not to grant a waiver for a financial interest that exceeds $50,000 and will allow those who receive a waiver for a lesser conflict to serve only as members who can participate in committee discussions but not vote.

The hallmark of this proposal is the flexibility it gives to ensure the committees will have the adequate expertise. If one or more experts with financial conflicts in excess of $50,000 have expertise that is essential to a committee, the Commissioner can grant the needed waivers. This is expected to be rare, but it can happen if needed.

Under the Durbin amendment, by contrast, the FDA can grant only one waiver per meeting. There is no flexibility on this point.

The FDA is already experiencing difficulty in filling vacancies on advisory committees. The Durbin amendment, no matter how well-intentioned, would worsen the problems, making it harder to fill critical vacancies and slowing the process of reviewing new medicines.

Let's look at the problem FDA is facing now. The Antiviral Drugs Advisory Committee needs six experts with specialized knowledge in the fields of clinical pharmacology, internal medicine, infectious diseases, microbiology, virology, immunology, pediatrics, and other specialties. These experts are needed to review the safety and effectiveness of new medicines for pandemic flu, HIV/AIDS, and other serious infections. The Anesthesiology and Respiratory Therapy Devices Panel has nine vacancies. The Ophthalmology Panel is in need of nine experts. The Advisory Committee on Peripheral and Central Nervous System Drugs needs six members--on and on down the list, the story is the same, critical vacancies, missed opportunities, and missed expertise. I am not for conflicts of interest. I am against them. But they are a fact of life.

We need policies that reflect the current reality of research in the life sciences. We have increased transparency in this legislation so there will be wide understanding of exactly how decisions are made. This is the most important. In the time of life sciences, we are talking about cross-fertilization of different ideas. Visit the Institute of Medicine. They are talking about the life sciences and work that is taking place. Flip a molecule and it could be relevant to alternative fuels. Flip it again and it can be relevant to agriculture. Flip it again and it can be relevant to the health sciences. We need all of these disciplines working together. To take one particular requirement and exclude the possibility of getting the best in terms of future scientists, we need integrity in the FDA, integrity in decisionmaking, integrity when they grant waivers. The public ought to have the right to know. We have a balance in here. Hopefully, we will retain it.

I withhold the remainder of my time.


Mr. KENNEDY. Mr. President, I yield myself 5 minutes.

I support the comments Senator Enzi has made about the fines. We are going to have to look at this in conference, and it is clear the House is going to raise the fines, it seems to me, as Senator Enzi pointed out. So we will have a chance to look at it in conference. I think that is probably the best way to do it.

Let me point out two other items--something I think most Americans have been concerned about in recent times. It was reported today that China has detained managers from two companies linked to contaminated foods. As a first step, we need to determine the extent of the contamination and see how far into the food supply this internal adulteration has gone.

Yesterday's report from the FDA that contaminated wheat flour from China was fed to fish raised for human consumption is another example of the need for a comprehensive examination of our food safety system. We also found out yesterday that what we thought was contaminated highly processed wheat gluten was actually unprocessed wheat flour spiked with melamine to make it appear to be higher quality.

A month ago, the FDA warned that certain types of pet food were suspected of being contaminated. Then, there were more kinds of pet food. Then it was hogs being fed the contaminated food, but those had been caught before human consumption. Then we found out that tens of millions of chickens eaten by people had been fed the tainted food. Yesterday, we were informed that fish raised for human consumption had been fed contaminated food.

The incremental expansion of this crisis raises serious concerns about the FDA's ability to rapidly identify the source of food-related problems and bring to bear the effective tools. We know the issue of food safety is divided into different kinds of committees, but it has to be of concern to American families.

We have included strong new protections to allow FDA to better ensure the safety of human and pet foods, but this is a first step. Senator Enzi and Senator Durbin have joined with me and others and we are committed to taking a comprehensive look at the safety of our food supply and we are committed to taking the actions, with our colleagues, needed to ensure that the foods our families and pets eat are as safe as possible.

As part of the managers' package adopted last night, we included important new provisions to allow the FDA to oversee the safety of farm-raised fish. We owe this--this is a story in the paper today--to Senators LINCOLN and PRYOR and SESSIONS on this important proposal.

This morning's newspaper talks about doctors reaping millions for the use of anemia drugs. People are going to wonder what we are doing in this bill, if anything, on this issue. Well, this is not what the FDA does exactly. It is safety and efficacy. But there are different agencies in what they call health research and quality. AHRQ has responsibility for this. We will be in touch with them to examine this issue and provide better guidance and recommendations to doctors and patients.

The FDA does not practice medicine. But this kind of action has to be of concern because it reflects itself in increased costs to the American consumer, and it does raise health issues as well.

So this is illustrative of the range of different areas of concerns the American families have. We believe we have made very important and substantial progress in trying to address those questions.

Mr. President, at this time I will withhold the remainder of my time.


Mr. KENNEDY. Mr. President, in a few minutes, we will be prepared to vote. I yield myself 3 or 4 minutes.

I will include in the Record, at the conclusion of this debate, the names of the staff on our committee who have done superb work. It has been extraordinary and on both sides of the aisle. We are enormously appreciative and grateful.

I am also personally appreciative of the work of my friend and colleague, the Senator from Ohio, Mr. Brown, who was here yesterday and filled in. I had the opportunity to travel to Ireland, where they signed and put in place, after 400 years of struggle, the democratic institutions over there, in a very moving ceremony, which President Bush had supported--a very special day.

This legislation is a reflection of 2 1/2 years of hearings under the leadership of Senator Enzi, when he was chair of the committee, and myself. It incorporates the Institute of Medicine's recommendations, by and large, after they had months and months of hearings. The American people ought to understand the legislation, which reflects bipartisan support in the Senate, is a reflection of the best judgments we could have as a result of months and years of working on this issue and of the membership on it. We are enormously grateful.

This legislation is going to make the prescription drugs our families take safer and our food safer. That is very important. It is going to ensure that the Agency has resources to do follow-on reviews to continue its important function to be the world leader, the gold standard, for safety for our people and the example for the rest of the world. So this is very important legislation.

We are reminded every day of the additional kinds of challenges we are facing in terms of safety for our families. We are very aware of it. Senator Enzi and I and the members of our committee are going to continue our study, our review, and continue our activity to ensure we are going to have the best in terms of a safe and secure food supply, pharmaceutical supply, and take advantage of this life science century so every American is going to have the best and, hopefully, at the most reasonable price, so they can have healthier and stronger families.


Mr. KENNEDY. Mr. President, the FDA has a new policy, a new procedure out there.

Basically, what the Durbin amendment says is, one size fits all. That concept has been rejected by the Europeans, rejected by the Canadians, and basically rejected by the Institute of Medicine. In this life science century, researchers who are looking at cancer drugs may be examining 15 different components. Are we going to say that if a conflict exists with one of those components that they meet the Durbin amendment standard. This would exclude some of the most knowledgeable people in this country from participating in the review of breakthrough drugs.

The FDA says they have adopted transparency. Everyone in the Senate is going to know who sits on the advisory committees. There is a financial limitation of $50,000 at the FDA now. Everyone is going to know the existence of any conflicts. It is a new day out there. We have now have transparency, but virtually everyone who understands that we are in the life science century says we have to have the best scientific minds at the table, and so the Institute of Medicine said: Don't go with a one-size-fits-all, which the Durbin amendment does.


Mr. KENNEDY. Mr. President, one of the great joys of serving in the Senate has been working with my friend and colleague from Wyoming, Senator Enzi, on different legislation. He does it the old-fashioned way. He believes that what we ought to do is have the hearings on the problem and then listen to various alternatives and then try to work out a solution and carry the process forward. That is the old-fashioned way. Today people look at different issues, file bills, and try and ward off interventions. He has a deep-seated conservative philosophical commitment. He and I differ on some matters, but we always try to find common ground. We have been able to find it certainly on this legislation and many other pieces of legislation. I look forward to continuing this tradition. I am personally grateful to him for all his help in guiding us. You can see the closeness of these votes. This is enormously important legislation to bring the Food and Drug Administration into the 21st century. But there are strong feelings, strong opinions, strong arguments on different ways to do so. We have legislation. It is solid legislation. We are proud of it. I think the overwhelming, virtually unanimous vote of the Senate on both sides is a vindication of the efforts our committee has made. It starts with Senator Enzi. I am grateful to him.

I see Sherrod Brown, the Senator from Ohio, was kind enough yesterday to stand in for me when I had the great honor to witness the coming together in Northern Ireland after 400 years of conflict and the establishment of democratic institutions in a very momentous historical moment. When I left Monday night, there was a certain element of chaos surrounding this bill, and coming back early this morning, under the great work of Senator Enzi and Senator Brown, we had an orderly path to proceed. He is knowledgeable about health issues and had a very distinguished record on health policy before he came to the Senate. He has not missed a beat in working through the issues. He has been invaluable to me personally and to our committee. I thank Senator Brown for all of his good work.

Quickly: I would like to thank my friend, Senator Dodd for his work on all of the issues that affect kids' drugs and devices; Senator Clinton for her work on drugs and devices; Senator Mikulski for her work on the issues of transparency, enormously important provisions on which this legislation depends; Senator Hatch for his work on antibiotics; Senator Gregg for his work on the databases and Web portal; Senators ROBERTS and HARKIN for their work on the direct to consumer advertising issue, which involves a lot of different policy issues and a lot of emotion and feeling. They worked very hard with the staff, we had very solid recommendations on this; Senator Stabenow for her work on the citizens' petitions in order to help get product onto the markets in a quicker way. I would also like to thank Senator Brown and Senator Brownback, for their enormously creative innovative idea with regard to neglected diseases. This is something the United States should be doing more of, and they have been very creative in coming up with an idea; Senator Coburn on the doctor-patient relationship, a subject matter he feels intensely about and has been helpful to us on the legislation; Senator Durbin on food safety provisions, very important and helpful; Senator Alexander on the children's drugs; Senator Allard on food safety issues; Senator Lincoln on food safety including the raised-fish issue.

These are some of the items. Again, we thank staff members: From my staff, Dave Bowen, David Dorsey, David Noll, and Caya Lewis, all who have spent a great deal of time and effort over these past weeks, Michael Myers and Carmel Martin and Missy Rohrbach, Tom Kraus, I thank them enormously.

I express appreciation to Senator Enzi's staff. If people try to find solutions, rather than perpetuate differences, it makes an enormous difference. That was certainly true of all the staffs on our committee. I thank Amy Muhlberg and David Schmickel and Keith Flanagan and Katherine McGuire, Shana Christrup; Senator Brown's staff: Ellie Dehoney; Senator Dodd: Tamar Magarik; Senator Mikulski: Ellen-Marie Whelan; Senator Hatch's staff: Patty DeLoatche, and Trisha Knight; Mike Woody from Senator Harkin; Senator Gregg: Liz Wroe; Senator Roberts: Jennifer Swenson, Mike Seyfert, and Kate Anderson; Senator Clinton's staff: Ann Gavaghan and Andrea Palm. I am sure I might have missed someone, but we will make sure they are included in the RECORD.

We thank all our colleagues and friends. We look forward to meeting with the House and reflecting the Senate's best judgment on the legislation.

Mr. President, over the past 10 days we have had a good debate about important issues affecting the safety of our Nation's citizens, about the drugs they use when they are ill, and about the food they eat every day.

S. 1082 will reauthorize two important user fee programs at the FDA. First among these is the prescription drug user fee program. In 2008, the program is projected to supply the FDA with nearly $400 million to help support new drug reviews and monitor the safety of drugs once they are approved and on the market. Additionally, the bill will reauthorize the medical device user fee program, which subsidizes the medical device review process. Both these programs speed new medical products to patients by enhancing the resources the FDA can devote to medical product review, without changing the standards that must be met for FDA approval or clearance.

These resources to enhance speedy access to drugs and biologics are balanced with several significant provisions that will improve postapproval drug safety. A public-private partnership involving the FDA will build a network of health care databases to gather far better information about the safety risks of prescription drugs. Expanded drug user fees would also be used to develop this active surveillance system for all FDA approved drugs.

The bill will create an additional risk-based method for approving and monitoring new drugs and biologics, called risk evaluation and mitigation strategies, or REMS. A REMS consists of a flexible collection of tools that the agency can apply to address the unique risks associated with a new drug. From labeling changes to postapproval safety studies to measures to assure safe use of a drug, the bill gives FDA important new authorities to address safety issues that arise after a drug is approved. For the first time, civil money penalties will deter noncompliance. The bill increases drug user fees to implement the REMS and enhance the postapproval drug safety system.

Furthermore, this legislation would improve transparency, strengthen the agency's science-based culture, and inspire the trust of the American public. For example, it would require the FDA to identify and disclose conflicts of interest among advisory committee members who provide the agency expert scientific recommendations.

It would also improve access to information for patients and health care providers by launching a pubic database with the results of clinical trials. A clinical trials registry would enhance patient enrollment and provide a mechanism to track the progress of clinical trials.

Finally, the legislation would establish the Reagan-Udall Foundation for the FDA to head collaborative research projects, among the FDA, academic institutions, and industry intended to improve medical product development and evaluation.

I appreciate Senator Dodd and Senator Clinton's leadership to promote the safety of drugs and devices used to treat children.

I thank Senator Roberts and Senator Harkin for working with Senator Enzi and me to design constitutionally sound, effective, and feasible controls on DTC advertising. The amendment we produced will ensure the information that ads provide is accurate, clear, and conspicuous without imposing a moratorium.

I commend Senators Stabenow, Brown, Lott, Thune, Coburn, and Hatch for coming to a solution on the issue of citizens' petitions. They were able to craft an amendment that ensures that only citizens' petitions with meritorious claims could delay approval of a generic drug and that frivolous petitions will not lead to unwarranted delays in the approval of new generic drugs.

I applaud Senator Brownback and Senator Brown for their novel proposal to encourage investment in new medicines for neglected tropical diseases. Their proposal entitles companies that develop new therapies or vaccines to a voucher allowing them a priority review at the FDA for a product of their choosing. It would provide pharmaceutical manufacturers a significant incentive without raising costs to consumers or relaxing the safety standards applied to the drug given priority review.

I would also like to draw attention to the essential amendment introduced by Senator Hatch, with important contributions from Senators Brown, Burr, Stabenow, and others. The amendment would close a loophole that did away with the incentive to bring old but never approved antibiotics to market. It would also establish a public process to identify drug-resistant infections that are orphan diseases and that could be treated with orphan drugs. Additionally, the amendment would make certain molecules that are a part of old active ingredients eligible for recognition as new active ingredients, provided they will be used for a new indication. This provision includes limits that would prevent pharmaceutical manufacturers from abusing the process to extend the life of old active ingredient drugs.

Finally, I am grateful to my friend, Senator Enzi, for his leadership and commitment to addressing prescription drug safety. We have worked together for over 2 1/2 years to develop this legislation, and I am proud of where we are today.

I have already thanked a number of people, and I would also like to thank, on Senator Enzi's staff, Ilyse Schuman, and on my own staff, Stacy Sachs, Molly Nicholson, Jeff Teitz, and Charlotte Burrows, and two of my interns, Ashley Bennett and Lara Mounir.

I would also like to thank the many other staff members, both on and off the committee, who did such great work on this bill: Carmen Green, Nancy Hardt, Paula Burg, Lisa German, Jessica Gerrity, Dora Hughes, Ed Ramos, Ben Klein, Jim Esquea, David Lazarus, Lisa Layman, Jenny Ware, Mary-Sumpter Johnson, Stephanie Carlton, and Jennifer Claypool.

I would also like to thank the legislative counsels Bill Baird, Amy Gaynor, and Stacey Kern-Scheerer for all of their hard work on this bill.


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