Press Release

Statement on PDUFA - June 2012

PhRMA June 26, 2012

Washington, D.C. (June 26, 2012) — Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO John J. Castellani issued the following statement today regarding reauthorization of the Prescription Drug User Fee Act (PDUFA):

“Today’s Senate passage of S. 3187, the Food and Drug Administration (FDA) Safety and Innovation Act of 2012, is the culmination of a multi-year effort on the part of biopharmaceutical companies, FDA, Congress, and stakeholders that featured unprecedented collaboration, public input, and bipartisanship.

“On behalf of the more than 650,000 employees of America’s biopharmaceutical companies, I enthusiastically thank Chairman Harkin, Ranking Member Enzi, Chairman Upton, Ranking Member Waxman, and members of both the Senate and House Committees for their dedication to a bipartisan, collaborative process. The final bill will enhance the efficiency of FDA’s human drug review program, and will help bring safe, effective, and innovative medicines to patients in a timely manner.

“The result of this process is evident in the permanent reauthorization of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act, which will improve medical care for children by driving research to create innovative medicines for use in pediatric patients. Bipartisan support for these programs was led by Senator Reed, Senator Alexander, Senator Murray, Senator Roberts, Representative Rogers, Representative Eshoo and Representative Markey.

“Congress also made significant policy changes that will help alleviate drug shortages and improve the integrity of the pharmaceutical supply chain.

“We look forward to continue working with Senators Burr and Bennet, as well as other stakeholders in the domestic supply chain, to complete work on track-and-trace legislation this year.” 

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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