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PhRMA Statement Regarding Prescription Drug User Fee Act Reauthorization

Washington, D.C. (May 30, 2012) — Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO John J. Castellani issued the following statement today:

“Today’s strong House vote in support of the Food and Drug Administration Reform Act of 2012 (FDARA) demonstrates once again the bipartisan appreciation for the success of and importance of the Prescription Drug User Fee Act (PDUFA).

“In recent years, our growing understanding of the complex mechanisms underlying many diseases has helped biopharmaceutical research companies move into promising new areas of research. FDARA will provide FDA with the resources necessary to help build new scientific and regulatory capabilities, support patient safety and promote ongoing biopharmaceutical innovation.

“By casting a positive vote to reauthorize PDUFA, members of both the House and the Senate, from both sides of the aisle, have acted in the best interests of America’s patients, who are often the first in the world to benefit from access to potentially life-saving new medicines.

“These patients include children. That’s why we applaud Members of Congress 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 successful programs will help to continue the progress made in this field by providing more certainty to the sponsors of important pediatric clinical trials.

“In passing PDUFA reauthorization legislation in such a timely manner, members of both the House and the Senate are helping to ensure that FDA’s access to the resources it needs – and, therefore, its ability to do its essential job – 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.

Find PhRMA Online:

For information on how innovative medicines save lives, visit: http://www.innovation.org

For information on the Partnership for Prescription Assistance, visit: http://www.pparx.org

For information on ensuring the flow of medicines during public health emergencies, visit http://www.rxresponse.org