Prescription Drug User Fee Amendments Of 2007

Floor Speech

PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007--Continued -- (Senate - May 01, 2007)

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Mr. REED. Mr. President, I believe the Food and Drug Administration Revitalization Act before us today raises and addresses issues that are critically important to the public's health and well-being. Congress has a historic opportunity to strengthen and increase knowledge about drug safety and effectiveness, bring more transparency to the process of drug approval and surveillance, as well as reassess the goals of the prescription drug and medical device user fee programs, and fortify and expand essential safety programs for children. The FDA Revitalization Act strikes a careful balance between these many important priorities and objectives.

Recent serious adverse drug events related to several widely used drugs on the market underscore the urgency with which we should address and improve drug safety in this country. Moreover, as the population ages and science inevitably advances, more and more drugs will come to market, presenting potentially groundbreaking health benefits to the public, but simultaneously increasing the need for sophisticated mechanisms for monitoring and assuring drug safety.

The FDA Revitalization Act is an opportunity to improve our current system of drug approval and drug monitoring, but it also adeptly anticipates changes in the future of prescription drugs and consumer safety brought about by advances in science and an ever expanding market for prescription drugs.

The primary mechanism this bill uses to strengthen drug safety is to strengthen and rearticulate the FDA's authority. The bill clarifies, and in some cases fortifies, the FDA's authority with regard to drug safety. Currently, if the FDA detects a problem, or a potential problem with a drug post approval, they have few options beyond what is often referred to as the ``nuclear option.'' That is, pulling a drug from the market. While the FDA's authority to pull a drug from the marketplace is a powerful tool, it is a blunt instrument. In order to prevent problems from spiraling into major public health crises, the FDA needs intermediary authority. The FDA's reluctance to pull a drug, potentially a drug upon which millions of Americans depend to manage an illness, unless it is overwhelmingly certain that the action is necessary, is understandable. However, prescription drug users suffer as a result since the ``nuclear option'' offers a forceful, but ultimately limited response. Pulling a drug from the market potentially delays action and places individuals at major health risks in the interim. On the flip side, pulling a drug prematurely may needlessly deny patients important, and in some cases, singular, treatments for their health needs. This bill offers what I believe is a good solution to this paradox; one that considers input from patients rights organizations, industry representatives, and the FDA, but ultimately places patients at the top of the list.

The risk evaluation and mitigation, REMS, system, the primary tool in the drug safety title of this bill, bolsters the FDA's intermediary authority to require drug manufacturers to monitor and provide important information regarding their products. By so doing, the FDA can actively require drug companies to provide information about the medications millions of Americans are taking and not just passively request drug companies to comply.

Most importantly, the REMS system focuses the FDA's efforts and resources on postmarket surveillance. Increased drug user fees would be used to review REMS as well as for general drug safety surveillance. User fee revenue will increase by $50 million to fund drug safety

activities, of which $30 million is authorized for the routine drug surveillance once they are marketed. Many of us would like to eliminate the need for industry paid user fees, but this arrangement, agreed on by industry and the FDA, offers the best workable solution in this strained budget environment.

Another important objective of the FDA Revitalization Act is to improve the integrity of the agency and to enhance transparency on its actions. I am pleased that this bill improves the public's access to information about clinical trials and, more importantly, the results of those trials. The bill enhances patient enrollment in trials by requiring late phase II, as well as phase III and phase IV clinical trials on drugs are registered in a publicly available database. This will improve the public's knowledge of important and potentially life saving clinical studies. The bill also creates a publicly available database of the results of those trials. This means, for instance, that a parent who wishes to understand why a much-talked about treatment for juvenile diabetes failed to advance past a clinical trial stage can track the progress of a treatment using this database. It is important that we empower patients and consumers to gather information from primary sources so that they can engage in treatment decisions and make informed choices regarding their family's health care needs.

I am also pleased to see efforts to increase research on pediatric drug safety, pediatric clinical trials, and pediatric medical devices in title IV of the FDA Revitalization Act. The bill includes reauthorizations of the Best Pharmaceuticals for Children Act, BPCA, championed by my colleague, Senator DODD, which I have cosponsored, and the Pediatric Research Improvement Act, PRIA, championed by my colleague, Senator CLINTON, which have been particularly successful at increasing the availability of pediatric specific data on drug products, as well as greatly expanding the number of treatments that have been tested and labeled for use in pediatric populations. The bill also includes a new proposal to expand the collection and availability of pediatric data on medical devices, an area of the medical device market that remains seriously underdeveloped, and as a result places infants and children at risk for inferior or inadequate care at best, and tragic and needless loss of life at worst. Moreover, BPCA also includes a new provision on patent exclusivity for blockbuster drugs that strikes a sound compromise between creating an appropriate financial incentive for drug companies to conduct much needed research, while also providing the FDA with important information about pediatric drugs.

Mr. President, the FDA is responsible for overseeing the safety of a wide range of products consumed by millions of Americans each and every day. We can and must ensure that this critical agency has the tools and resources it needs to perform the myriad of tasks under its purview. We need to get this right for the millions of Americans who rely on the FDA to approve the drugs that they take to treat serious illnesses. The FDA Revitalization Act creates an opportunity to improve science at the FDA, strengthen drug safety by devoting resources to postmarket surveillance, and ``revitalize'' the FDA's authority.

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