ENZI SUPPORTS BILL TO GIVE FDA AUTHORITY, RESOURCES TO ENSURE PATIENT SAFETY, SAYS MORE WORK IS NEEDED

Washington, D.C. –U.S. Senator Mike Enzi (R-WY), Ranking Member of the Senate Health, Education, Labor and Pensions (HELP) Committee, today announced an important first step toward protecting American consumers and patients as the HELP Committee approved a comprehensive bill to enhance drug safety, provide key resources to review new drugs and medical devices, and ensure that drugs and devices for children are safe and effective. Enzi added that the bill, the “Food and Drug Administration Revitalization Act,” is by no means a finished product, and said that he will continue to work with colleagues on both sides of the aisle to improve the bill as it moves to the Senate floor in order to best protect the health and safety of all Americans. The bill was approved by a vote of 15-5. “As today’s debate demonstrated, there are legitimate concerns about the potential unintended consequences of this bill and the amendments that were offered,” Enzi said. “I look forward to working with the Members of the HELP Committee in the coming weeks to address the concerns outlined in their amendments, and I am confident that we can work together in a bipartisan manner to strike the right chord for patient safety.” The “Food and Drug Administration Revitalization Act,” S. 1082, establishes a system of active surveillance for drugs already on the market though Risk Evaluation and Mitigation Strategies (REMS). The bill explicitly gives the FDA new authority to measure the risks of drugs on the market and to respond quickly and appropriately when previously unknown risks arise. “Many people are asking, ‘Why REMS? Why now?’” Enzi said. “The answer is easy. Right now, the FDA has its hands tied behind its back when it tries to manage the risks of drugs already on the market. This bill will clarify and strengthen the FDA’s authority and give it new tools to take measured and appropriate steps to protect the health and safety of Americas, when the agency’s post-market surveillance signals potential dangers from a drug or therapy. Pulling a drug from the market and denying patients who need it shouldn’t be the only tool available to the FDA.” “The authority of the Food and Drug Administration (FDA) touches the lives of all Americans – from infants to the elderly, animals that provide the food and fiber for living, and even our pets,” Enzi said. “We need to restore peace of mind for Americans who are buying drugs for themselves and their children.” “Like everyone else, when I purchase a product for myself, my children, or my grandchildren, I want assurance that the product is safe and beneficial,” Enzi said. “Safety must be at the forefront of every decision the FDA makes during the life of a drug, so that Moms and Dads are able to trust that the products at the pharmacy counter are safe and effective.” “Imagine a system that gives the FDA, through sound science and remarkable innovation, the tools to get drugs to the market quickly and efficiently, especially when lives are on the line and people need new drugs and therapies. Imagine also a system that gives the FDA new authority to take swift, appropriate, and decisive action to ensure patient safety and protect consumers when new information comes to light to expose unexpected risks. We can make this a reality.” The full text of Senator Enzi’s statement is available at http://help.senate.gov. ####The Food and Drug Administration Revitalization Act Summary Title I — Prescription Drug User FeesTitle I codifies the user fee agreement reached by drug and biotech industries with the FDA. It establishes an overall amount for user fees of nearly $393 million for 2008 (which will be adjusted upward based on 2007 workload). It includes the expansion of use of drug user fees by nearly $30 million for post-approval drug safety programs. Title I also includes the FDA-industry proposal to create a voluntary user fee program under which drug companies can submit direct-to-consumer television advertisements to the agency for review before they are distributed.