SENATE SET TO DEBATE KEY DRUG SAFETY BILL

Washington D.C. – U.S. Senator Mike Enzi, R-WY, Ranking Member of the Senate Health, Education, Labor and Pensions Committee (HELP Committee), today said that the Senate has an opportunity to approve a bill to clarify and strengthen the Food and Drug Administration’s (FDA) authority and give it new tools to take measured and appropriate steps to protect the health and safety of all Americans, as the Senate begins to debate drug safety on the floor. “The Food and Drug Administration Revitalization Act, which we will be discussing this week on the Senate floor, is 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 said. “I look forward to an informative and thorough debate on this critical legislation” “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,” Enzi said. “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.” “We have the opportunity this week to renew key FDA programs, and to ensure that the FDA continues to operate with new tools to ensure that safety is forefront of every decision during the life of a drug.”The bill being brought to the floor today represents over a year of bipartisan discussions and cooperation following the Vioxx incident. It establishes a system of active surveillance for drugs already on the market, and explicitly gives the FDA new authority through Risk Evaluation and Mitigation Strategies (REMS) 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 give FDA new tools to act 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.” ####