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FDA NEEDS NEW SAFETY AUTHORITY AS CONGRESS RENEWS PRESCRIPTION DRUG USER FEE ACT, ENZI SAYS


Washington, D.C. – U.S. Senator Mike Enzi (R-WY), Ranking Member of the Senate Health, Education, Labor and Pensions (HELP) Committee, today said the renewal of the Prescription Drug User Fee Act (PDUFA) must provide the Food and Drug Administration (FDA) new tools to better identify and manage safety issues and ensure that Americans never again experience a drug lag in approving revolutionary new therapies. “PDUFA had a tremendous effect on the number of available new therapies, particularly for conditions such as AIDS and cancer. It effectively ended the drug lag of the 1990s, when foreign countries left us behind in bringing revolutionary therapies into common use,” Enzi said today. “However, now is not the time to pat ourselves on the back; it is the time to move forward with further improvements. America is not a ‘rear view mirror’ country. We are a pedal to the metal country – always optimistic and looking to the future, always looking at how to make things better.” “While the PDUFA program has been a success, it can and should be improved to make certain that America maintains its place as the world’s leader in drug safety and innovation and by expanding rapid access to new therapies but still improving safety.” During today’s HELP Committee hearing, “Drug User Fees: Enhancing Patient Access and Drug Safety,” Enzi said the rapid expansion of available therapies, and their success in managing life-threatening diseases as chronic conditions begs a new approach to drug safety –requiring new legislation that goes hand in hand with PDUFA. The “Enhancing Drug Safety and Innovation Act.,” which Enzi and Senator Edward M. Kennedy (D-MA) HELP Committee Chairman, have introduced, would provide the kind of support FDA needs.“Patients still want safe drugs but they don’t want to die waiting for them. But to meet that goal, the FDA needs new authorities to acquire and evaluate safety information and act on it promptly,” Enzi said. “We need both new therapies and timely access to more information about those therapies. PDUFA provides an important part of that, but it cannot do it all.” As work on renewing PDUFA moves forward, Enzi urged Congress to carefully rethink its commitment to FDA, suggesting higher and higher demands being placed on the agency’s resources will require more than the user fees from drug manufacturers included in PDUFA to keep pace with rapid advances in medicine and technology. “User fees were never intended to supplant appropriations – they were intended to supplement appropriated funds. The industry has committed ever-increasing amounts of money. The agency has committed to meet ever more ambitious performance goals,” he said. “Now congress needs to demonstrate its commitment to drug safety by giving FDA the tools it needs.” ###