Press Release

Statement on PDUFA - June 2012

PhRMA June 18, 2012

Washington, D.C. (June 18, 2012) — Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO John J. Castellani issued the following statement today:

“PhRMA applauds today’s introduction of the Food and Drug Administration Safety and Innovation Act of 2012 (S. 3187), and thanks Congress, the Food and Drug Administration (FDA), and other stakeholders who have participated in the months and years of work to negotiate and pass this important legislation.

“Specifically, we thank Chairman UptonCongressman WaxmanChairman Harkin, and Senator Enzi for their leadership in successfully moving bills through the House and Senate, as well as for conducting successful negotiations to resolve differences between the bills. By enhancing FDA’s regulatory environment, the Food and Drug Administration Safety and Innovation Act of 2012 will directly benefit patients and support continued biopharmaceutical innovation throughout the United States. 

“The Food and Drug Administration Safety and Innovation Act of 2012 reauthorizes several programs that are critical to public health and support of innovation, including the Prescription Drug User Fee Act (PDUFA). Reauthorization of PDUFA will enhance the consistency and efficiency of FDA’s human drug review program, and will help bring safe, effective, and innovative medicines to patients in a timely manner.

“Likewise, permanent reauthorization of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) will improve medical care for children by driving research to create innovative medicines for use in pediatric patients.

“In addition to reauthorizing PDUFA, BPCA, and PREA, the Food and Drug Administration Safety and Innovation Act of 2012 includes key provisions that: enhance FDA’s ability to address increasingly complex products and regulatory issues, particularly in therapeutic areas of unmet medical need, while maintaining the gold standard of safety and effectiveness of the medicines they regulate; provide new tools to detect and mitigate drug shortages; strengthen ‘upstream’ supply chain protections against counterfeit and adulterated biopharmaceuticals; and support the development of new, safe and effective antibiotics.

“Furthermore, this timely reauthorization of PDUFA will ensure that the biopharmaceutical research sector continues to thrive and play an important role in the U.S. economy. As of 2009, the U.S. biopharmaceutical sector directly provided more than 650,000 jobs, supporting a total of about four million jobs in the United States. The reauthorization of PDUFA will help enable the sector to play that vital role by continuing to invest billions of dollars in research and manufacturing all across the country.

“It is important to highlight a critical issue that was not resolved in this legislation – ‘downstream’ supply chain security. Protecting American patients from counterfeit and adulterated medicines is a public policy priority for PhRMA, Congress, FDA, and a multitude of stakeholders, and we commend Congress’s efforts to address this issue.

“Though ‘downstream’ supply chain security is not part of the Food and Drug Administration Safety and Innovation Act of 2012, this year’s reauthorization process has brought us closer than we have ever been to a viable solution to this important problem. We specifically thank Senators Burr and Bennet and Representatives Bilbrayand Matheson for their leadership, and we strongly encourage Congress to continue working to pass legislation that establishes a national uniform system to protect our drug distribution system, from manufacturers to dispensers, this year. We stand ready to support and actively engage in any legislative process to achieve this goal.

“Finally, this year’s reauthorization of the user fee program was a significant priority for PhRMA, and we are grateful for the overwhelming, bipartisan support that has enabled the introduction of the Food and Drug Administration Safety and Innovation Act of 2012 in such a timely manner.”

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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