Press Release

Statement on PDUFA - May 2012

PhRMA May 24, 2012

Washington, D.C. (May 24, 2012) — Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Matthew Bennett issued the following statement today:


“Today’s Senate vote passing the Food and Drug Administration Safety and Innovation Act demonstrates bipartisan recognition of the importance of the Prescription Drug User Fee Act, an extremely successful program that helps bring innovative medicines to patients. By reauthorizing PDUFA, members of both sides of the aisle have taken an important step forward toward providing the FDA with much-needed resources and management tools to support patient safety and to promote innovation through increased consistency and efficiency in FDA’s science-based human drug review program.


“We also applaud members of the Senate for their support for permanent reauthorization of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) – programs that have encouraged increased research into the use of medicines in children, helping us make significant advances in the care that children receive. Permanent reauthorization of these patient-focused programs will help to continue the progress made in this field by providing more certainty to the sponsors of important pediatric clinical trials.


“This bipartisan effort on timely reauthorization of PDUFA provides the opportunity to ensure the FDA’s ability to review new medicines, which provide hope to patients suffering from debilitating diseases, is not impeded.”


The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $49.5 billion in 2011 in discovering and developing new medicines.


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