PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007 -- (Senate - April 30, 2007)
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Mr. KENNEDY. Madam President, this week the Senate has the opportunity to set a new and better direction for the safety of the prescription drugs and medical devices that make such a profound difference in the lives of our people.
Every day, families across America rely on the Food and Drug Administration in ways they barely realize. When they put dinner on the table, they are counting on the FDA to see that the food is free from contamination. They trust the FDA to make sure the drugs they take are safe and effective. From prescription drugs, to pacemakers, to chemotherapy, to the food we eat, the FDA protects the health of hundreds of millions of Americans and monitors products that account for a quarter of the Nation's economy.
The FDA should be the ``gold standard'' for safety, but its luster has been tarnished in recent years for failure to protect the American people from unsafe drugs. The public was shocked that the arthritis drug Vioxx was able to stay on the market for 5 years, even though it nearly doubled the risk of heart attack and stroke. Antidepressants used by millions were found to increase the risk of suicide in adolescents. Millions of Americans have needlessly been put at risk, and they want action by Congress to reform and strengthen the agency.
We are responding now with bipartisan legislation that is the product of months of work in our committee. I commend my colleague and friend in this effort, Senator Enzi, for his work on this proposal that will improve the way FDA oversees the safety of drugs. Almost half of all Americans take at least one pill a day, so this legislation will make a difference in the lives of every American family. Our proposals were strengthened by our colleague from New Hampshire, Senator Gregg.
Safety is at the core. Our legislation was guided by the recommendations of the impressive report by the Institute of Medicine on the ``Future of Drug Safety.'' Its major recommendations for reform are included in this legislation.
This chart I have in the Chamber gives the major recommendations for the Food and Drug Administration: Build the internal epidemiology and informatics capacity in order to improve the postmarket assessment of drugs, have postclinical trial results in a public database, have regularly analyzed postmarket study results. This aspect about postmarketing surveillance is a key in terms of drug safety. We have included their recommendations. Another is: Give the FDA better enforcement tools. I am going to refer to that in a moment. Another is: Conduct regular evaluation of new drug safety profiles. We have included that. I will expand on that point in a few moments. Another is: Substantially increase drug safety resources available to the FDA. We have also included those.
So those were recommendations from the Institute of Medicine. We have reviewed the same subject matter. We evaluated those very carefully and we have taken the major recommendations in terms of safety and included them in this legislation.
A small number of health systems in America--now referring to postmarketing surveillance and the use of electronic records--effectively links the surveillance of various kinds of prescription drugs to safety databases. These systems--Kaiser Permanente, Mayo Clinic, Veterans' Administration--have the means to examine whether Vioxx and other drugs were being used effectively. They found these drugs were being prescribed inappropriately, and they took steps to curb their overuse. As a result, they approved the use of these medications only for patients who had no other options. Overuse went down and safety improved.
The use of these databases should not be limited to the few health systems that currently use them. FDA should make use of every aspect of modern health care technology to safeguard the public's health. Mark McClellan, the former FDA Commissioner, calls these kinds of systems health IT for drug safety. Our proposal includes his recommendations.
Surveillance is essential, but effective action is needed when a safety problem is detected. Each drug has unique risks and benefits. There can be no one-size-fits-all approach to drug safety. That is why our legislation includes a flexible but effective program for safety. We call it a risk evaluation and management system. It can be tailored to the unique characteristics of each drug. It gives the FDA the authority to act when action is needed to protect public health, but it also contains safeguards to prevent such action from being imposed when there is no reason to do so.
For some drugs, it is essential to require postmarket studies, yet FDA today lacks the basic authority to require such trials to be conducted. FDA can request them but it cannot require them, and has few ways to see they are completed. As a result, companies routinely promise to conduct studies that are never even started, much less completed.
This chart I have in the Chamber shows how, under current law, postmarket studies are not completed. These are the studies that have been requested by the FDA because they are for sound safety reasons. Yet 71 percent of them were not even started. Our legislation says when they are required and recommended by the company, they must move ahead.
In its recent report on drug safety, GAO pointed out the failure of the current system. Its report states:
In the absence of specific authority, FDA often relies on drug sponsors voluntarily agreeing to conduct such postmarketing studies. But the postmarketing studies that drug sponsors agree to conduct have not consistently been completed. The FDA has little leverage to ensure that the studies are carried out by imposing administrative penalties.
Our legislation solves this problem. It gives the FDA clear authority to require the conduct of the postmarketing studies when there is a public health need to do so, and it gives the FDA the ability to assess fines on those who ignore their responsibilities.
Databases and postmarketing studies help detect problems, but the FDA needs the ability to take other action to protect the public health. Here, too, the current law is inadequate. FDA lacks clear authority to require measures to protect public health. When lives are on the line, doctors are making the critical decisions. But because FDA's authority is so unclear, it must first call the lawyers for their opinion as to whether the agency can act. The Institute of Medicine identified this major weakness of
current law and called on Congress to give FDA the authority to require risk management programs when needed to protect health. These programs can be as simple as new information on a drug label or an advisory notice to doctors or as sophisticated as special monitoring of programs for patients who use a particular drug. The legislation does not make the decision about which measures should be taken for which drugs, but it does give the FDA the authority to make the right choice for the public health. This authority has been lacking in the past.
For Vioxx, it took 14 months to change the drug's label to warn doctors and patients of the danger. Because FDA had weak authority, it had to ask the manufacturer to change the label voluntarily, and the manufacturer stalled and stalled. When patients are in danger, FDA should not have to wait to get legal opinions to decide how to protect health. It should be able to act immediately, and our bill gives them that authority.
In many cases, companies have hidden evidence of safety problems. Our bill addresses this abuse by including a public database of all clinical trials and their results. Listen to that: all clinical trials and their results. We protect the trademark aspects of the particular item but require the publication of all clinical trials and their results. A company will no longer be able to hide the results if they do not show what the company wanted.
Some would say any increase in drug safety will inevitably decrease access to needed drugs, but that is a false argument. Consider the situation now. When the FDA is confronted with a new drug that may impose safety risks, or where additional study may be required, with little expectations that those risks will be mitigated by a voluntary approach--and with no ability to ensure that the studies are going to be conducted--FDA might reasonably conclude the risks of approving the drug are too great and, therefore, not approve it.
Under our legislation, the calculation is reversed. With this bill in place, FDA could allow patients to have access to the drug, secure in the knowledge that effective safety measures were in place. That is not my judgment; it is the judgment of a coalition of advocacy organizations representing over 30 million patients. This coalition, the Alliance for Drug Safety and Access, wrote Congress a letter saying:
[T]his legislation gives the FDA the ability to continue to study the safety of drugs after approval, flexible enforcement tools necessary to ensure compliance with these new safety protections, and additional funding to support these new activities. Allowing the agency to act on clear safety signals could actually allow the FDA to approve drugs more quickly, knowing it will have the ability to respond on behalf of patients if safety concerns appear postmarket.
That is support from the organization that has been put together that is protecting safety for the consumers. That is the balance our legislation strikes: greater safety, hand in hand with better access.
As our debate continues, I will discuss additional aspects of the legislation, especially its new ideas for accelerating drug development, its renewal of our commitment to safe and effective drugs for children, and its provisions to improve drug science, and increase the transparency of the FDA.
We are also working with our colleagues from Iowa and Kansas, Senator Harkin and Senator Roberts, on ways to refine our provisions on direct-to-consumer advertising, to make certain they are consistent with the Constitution. We are working with Senator Durbin and other colleagues on the committee on proposals for food safety on pet food. These bipartisan proposals are being readied for floor action shortly. I look forward to further discussions on them.
Our committee will continue to work to improve the ways FDA can monitor and improve food safety. In this new era of life sciences, medical advances will continue to bring immense benefit for our citizens. To fulfil the potential of that bright future, we need not only brilliant researchers to develop the drugs of tomorrow but also strong and vigilant watchdogs for public health to guarantee that new drugs and medical devices are safe and beneficial, and that they actually reach the patients who urgently need them.
Congress has ample power to restore the luster the FDA has lost in recent years. The legislation we are now considering represents a bipartisan consensus on the best way to get the job done.
I want to mention a few additional items. I am quoting now from the FDA's report brief on 2006:
The Food and Drug Administration's authorities must be clarified and strengthened to empower the agency to take rapid, decisive action when necessary and appropriate. FDA lacks the clear, unambiguous authority needed to enforce sponsor compliance with regulatory requirements and, instead, relies on the process of productive negotiations with the industry.
We have taken that. That is their No. 1 statement.
Included in that we have--this is the IOM committee.
The committee recommends that the FDA ensure that the FDA has the ability to require postmarketing risk assessment and to monitor and ensure the safe use of drugs.
We have done it.
These conditions may be imposed both before and after approval of a new drug, a new indication or a new dosage.
We have incorporated those concepts, as well as the identification of some new contraindications or patterns of adverse effects.
It talks about the distribution, conditioned on compliance, with agency-initiated changes and drug labels. We have achieved that. Conditioned on specific warnings, proposal materials, distribution conditioned on a moratorium, on direct consumer advertising. We have at least addressed that.
It also includes distribution of restrictions for special training, if need be, for pharmacists and physicians. It also has distribution conditions on the performance of specific medical procedures. It talks about clinical trials. FDA needs increased enforcement authority, better enforcement tools directed at drug sponsors which should include fines and injunctions and withdrawal of drug approval.
We haven't taken every one of these recommendations--not every one precisely--but we have taken the essence of these recommendations, and we have included those that are as a result of our extensive hearings. I could go on with this, and will later on perhaps, but I won't today. I wish to mention, finally, the various groups.
We mentioned the Alliance for Drug Safety and Access. I will include these letters of support. This is to Senators KENNEDY and ENZI:
On behalf of the Alliance for Drug Safety and Access, we write today to express our support for the goals of titles I and II of S. 1082, the Food and Drug Administration Revitalization Act.
It will continue the timely access of patients to new therapies and will improve the ability of the Food and Drug Administration to ensure safety of drugs already on the market.
S. 1082 takes a life-cycle approach to the risk-benefit assessment of drugs and biologics--
This is so, though we have not included biologics in this proposal with regard to drugs as endorsed by the Alliance and recommended by the Institute.
We are pleased that this legislation gives the FDA the ability to continue to study the safety of drugs after approval, flexible enforcement tools necessary to ensure compliance with the new safety protections, and additional funding to support these new activities.
It allows the FDA to approve drugs more quickly, knowing it will have the ability to respond to the patients if safety concerns appear afterwards.
This represents a group of at least 30 different health organizations that have followed this most closely.
We have a letter that has been sent to Senator Enzi and myself, Senator Dodd and Senator Clinton, talking about how this legislation impacts children and giving special recognition, as they should, to our colleagues and friends, Senator Dodd, who has been such a leader in this area, and Senator Clinton as well, who has been so thoughtful in this area.
It points out the Pediatric Medical Device Safety Improvement Act of 2000 provides a comprehensive approach to ensure that children are not left behind in cutting-edge research and revolutionary technologies for medical devices. It talks about swift action and passage.
The American Psychiatric Association talks about how the provisions of this bill will ensure the Food and Drug Administration is equipped with the necessary tools to enhance its consistency, transparency, and accountability in ensuring the safety of drugs postapproval.
The American Psychiatric Association advocates for patient safety and supports further postmarket research of medications to ensure the safety and efficacy of medications used to treat mental illnesses. The letter says:
We look forward to working with you to rebuild the Administration's reputation and creating a universal drug safety monitoring system that is reliable and dependable.
They indicate their strong support for the legislation.
Again, another letter of support from the American College of Pharmacy, and it talks about the particular emphasis we have placed on improving science knowledge, which improves their decisionmaking regulatory oversight. Science knowledge grows on a daily basis. We know we are in the life science century. We want that agency, the FDA, to have the best in terms of science and science knowledge, and we have included special provisions to enhance that particular effort, and this association has recognized that.
We also have a letter from the Consumers Union, and they talk about their strong support for this legislation. They oppose any weakening amendments of this important legislation. It also has some reference to some of the recent polls which point out that 96 percent of Americans agree that Government should have the power to require warning labels if safety problems are identified, with 80 percent of those strongly agreeing to that authority. Right now the FDA has to negotiate safety warnings.
It also talks about the strong support the American people have for the FDA, which doesn't have the authority to provide studies to be performed once the drug is on the market. The American people are way ahead of us. They also show strong support to make public the clinical trial studies. This bill does that. Sixty-eight percent of the American people strongly agree the drug studies should be made public.
Eighty-four percent of the American people believe advertising for prescription drugs with safety concerns should be prohibited. Then it continues: Three-quarters of consumers agree that drug ads lead to overprescribing, with 38 percent strongly agreeing and 59 percent agreeing that the Government should restrict advertising by pharmaceutical companies altogether. We haven't gone that route, but we have taken safety considerations to heart.
Then the other letters from the Cardiovascular Association that talk about the particular provisions dealing with children, the pediatric provisions in here which are enormously important, and other letters. I ask unanimous consent that the appropriate representative group of letters be printed in the Record and the references to some of the editorials from across the country--I am not going to ask that they all be printed, but I will ask that selected ones be printed in the RECORD and that other newspapers be referenced showing strong support.
There being no objection, the material was ordered to be printed in the Record
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Mr. KENNEDY. Madam President, we have very solid legislation that is going to make a very important difference--very important difference in protecting the American consumer. We now have in place leadership at the Food and Drug Administration; for 5 of the last 6 years that has not been so. We have in place leadership, and we are going to give that agency the kind of tools necessary for protection the American people are entitled to and to restore the kind of luster that should go with the Food and Drug Administration, which is so important to the health and well-being of American families.
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Mr. KENNEDY. Madam President, I was necessarily absent from the Senate at the conclusion of Senator Enzi's remarks. I again thank him for an excellent presentation, with the emphasis on the safety aspects of this legislation.
I think all of us are reassured we are on the right track, not only as a result of the extensive hearings we held but the very extensive review the Institute of Medicine gave, a highly regarded, highly respected agency. During the course of the hearings, we had very good attendance and exchange of the representatives of the Institute of Medicine, and we have worked with them subsequently in terms of the language and refinements.
As we said, we didn't just copy everything, but the essential aspect of the safety provisions in our legislation is, quite frankly, preferable.
I look forward to working closely with Senator Enzi as well on the other areas of public policy in terms of food safety and the follow-on biologics which we are very much involved in as well.
I thank the Senator from Ohio for his comments. We know him for being someone who has spent a great deal of time making sure safe drugs are going to get to people who need them. There are many dimensions to this debate. He has certainly been one whom, over the course of time, on the Health Committee in the House of Representatives, I have had an opportunity to work with on a number of health issues. He has been very active and involved with this issue on our committee and also on making sure we are going to have not only safe drugs but also have access to them.
I will take a moment, because I think it is probably worthwhile in the opening presentation, to go through one of the real safety crises we had with prescription drugs and look at what existing authority was there and then how that could have been handled under that legislation.
People will look through this legislation--it is not all that long, but it is complex. The results are enormously important and very basic and very fundamental. I use Vioxx as a point of illustration, which I think most Americans remember the circumstances where hundreds of thousands of Americans with heart needs were put at risk.
This was really the question--this is the FDA Reauthorization Act--how we could have averted the Vioxx disaster. I think people are beginning to study this legislation, and also our colleagues who are reviewing the record ask about how this legislation can make a difference on a particular drug. This chart is very useful in understanding that point.
Can the FDA quickly detect safety problems with a drug? Vioxx, no. Under our legislation, the answer is yes. Senator Enzi gave an excellent presentation about how that can be done using the most modern technology, using the greatest availability of public and private collections of adverse reactions, and bringing those together within the agency. We know all of that is going to gradually expand in the future, so that agency will have the best of science. They will be able to protect safety. The answer with this legislation is yes.
Can the FDA require label changes to warn of safety problems? The answer with Vioxx was no. They spent 14 months trying to negotiate the issue of the labels. Under our legislation, they would be able to do that.
I mention that as one of the things they will be able to do. They can either take the drug off the market--they have the power to do it. It is not done because you don't want to take the chance that there may be some people in the public, given the health risks, who are justified in taking that particular medication, but for the great mass of people, it might not be. Can we put label changes on? They would be able to do it very quickly.
Are companies stopped from hiding safety problems? This comes back to what both Senator Enzi and I referenced in making public clinical trials. That is enormously important. Senator Mikulski has been very involved in the transparency parts of this legislation. I hope those in the Senate who are interested and concerned about the issues of transparency might take a moment and talk with Senator Mikulski. Hopefully, she will speak on these issues because she has made a very important contribution.
Part of this transparency is that these clinical trials will be available, to understand the significance of any safety problems, which hasn't been the case, but they will also be available to people who may want to enroll in a clinical trial, who have a particular illness, a particular disease and know there is a particular trial that is going to take place and say: I think I want to enroll in that particular trial because it is taking place. People don't know that now. That is enormously important and valuable to people. Whoever becomes part of a clinical trial and finds out a particular drug can be lifesaving, it is of enormous importance and consequence.
We have the knowledge of the clinical trial in terms of safety but also in terms of the opportunities that are coming up, particularly in this period of life sciences, with these extraordinary breakthroughs we are seeing now--the mapping of the human genome, sequencing of the gene, and I think before long in stem cell research we are going to see incredible possibilities, and people are going to want to become part of clinical trials.
But with regard to responding to this--are companies stopped from hiding safety problems, yes; does FDA have flexible tools to enforce safety decisions--it was expressed very well by Senator Enzi. He was talking about the big toolbox. That is the way we should look at it. There is a variety of tools in that toolbox. He explained that. There are a number of different ways that those who are committed to safety can titrate these different availabilities to ensure safety. Some may require a heavier hand than others. What we want, obviously, is to do enough to provide protection but not enough to discourage use where it is necessary.
Finally, is FDA the gold standard for protecting public health and assuring access? We are strongly committed to making sure it is. We believe that with the safety protections we have put in the bill and also the inclusions, working with the pharmaceutical industry in terms of PDUFA and MDUFA to try to always find ways of expediting the consideration of these lifesaving drugs--that was one of the very important purposes, giving emphasis for research of many of the areas of health that are of such concern to the American people: cancer, cardiovascular issues, Parkinson's disease, Alzheimer's disease, juvenile diabetes disease, the AIDS virus, and many others--we can try to move toward a better relationship between the companies and FDA, in the sense that we can move this process, move more quickly, but do it more safely. That is what we are attempting to do, to ensure, in this life science century, that these breakthrough opportunities are going to be available and also do it in a way that will be safe. This is an example of one of the challenges the country has been facing recently, between the old and the new.
We have tried this afternoon to describe in greater detail the various provisions of the legislation. We have not spent a great deal of time on the provisions which were supported by the Senator from Wyoming and myself with regard to children. Our committee has recognized, through the good work of Senator Dodd and Senator Clinton, the fact that children are not just little grownups; they are children. Many of these substances have different reactions, different impacts in terms of their development. It has taken special kinds of focus and attention to try to be more responsive to those needs. Our committee has done that. As a result, we see strong support from the American Pediatric Society and others for the way we have addressed those issues and modernized provisions to encourage greater research but also to protect the interests of children. We have strong support from the various groups that have spent their lifetime speaking for children.
We will probably have an opportunity to get into some greater detail in discussion of those provisions. As I mentioned briefly in our comments, we have recognized the importance of developing and upgrading the science function in this agency. We think the FDA--at a time we are having breakthroughs in knowledge, in science, in so many areas, we want to make sure the FDA is out there on the cutting edge with respect to these breakthroughs and know where they are going. We have paid particular attention to those as well.
Then the Udall-Reagan Foundation is to try to look longer term at ways in which the agency functions and take a longer look to make recommendations to the private sector and to the public sector about how it can be more effective generally. That kind of idea has not been included in the past. It can very well be enormously valuable and helpful to legislators in the future.
We have tried to get legislation that will provide the protection presently, help and assist breakthrough technologies, and provide a faster track for the American people in the future, but to do it with greater safety protections for all families, and to recognize we are at a time of breakthrough science, which that agency has to have, and there are going to be breakthroughs in different modalities in that agency working in the future. We have tried to build into this an agency that can give us advice so we can be more effective in the future.
I hope we will be able to move ahead. I know we have gone through, in careful detail, the administration's positions over the weekend. We certainly respect those. We have had a good exchange with the administration.
For those who are interested, if they read through the letter they sent to Senator Enzi and myself, and then if they look at the recommendation of the Institute of Medicine, they will find we are much closer to the recommendations of the Institute of Medicine. We may face some amendments in those areas. We look forward to having a good discussion and debate and the opportunity to expand some of the points we have made this evening.
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Mr. KENNEDY. Madam President, we have the legislation before us. We hope those who have an interest and have some ideas, have some amendments, will be in touch with Senator Enzi and ourselves through this late afternoon, early evening, or first thing in the morning. We want to try to address those amendments early in the day, as early as we can. We understand both parties have their lunches and have important matters to discuss, and I am sure this will be among them. But we are ready for any of the amendments, as I underline what Senator Enzi has said. We had great participation in our markup with the members of our committee. As he mentioned as well, we have had enormous involvement of our committee members and many others over the period since the legislation was reported out of our committee until now.
We are still in the process of trying to do business because we think this legislation is so important. We hope those who do have amendments will be in touch with us at the earliest possible time.
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