PhRMA Statement on House Passage of PDUFA Bill

Washington, D.C. (July 11, 2007) — Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO Billy Tauzin issued the following statement today on the U.S. House of Representative’s passage of the Prescription Drug User Fee Act (PDUFA) reauthorization legislation:

“The House of Representatives took an important step today to ensure that the Food and Drug Administration (FDA) has the resources necessary to protect and promote the public health. The House’s approval of the FDA legislation, including reauthorization of PDUFA, the Best Pharmaceuticals for Children Act, the Pediatric Research Equity Act and other key programs, reflects the constructive, balanced debate that took place in committee.

“Since its original enactment in 1992, PDUFA has been a resounding success for the FDA, pharmaceutical research companies, taxpayers and, most importantly, patients. The resources and additional staffing made possible by the fees charged by the FDA have enabled the agency to review new medicines more efficiently, while maintaining its stringent safety and efficacy standards.

“Overall, the legislation passed by the House will preserve – and even strengthen – the FDA's ability to do its job. Patients will continue to have timely access to innovative therapies, and they can be assured that the medicines they receive are reviewed under the most rigorous standards in the world today.

“The significant increases in user fees will provide the FDA the resources necessary to improve and modernize its already strong drug safety system. The agency will be able to hire key staff for drug safety activities and enhance its use of epidemiology studies and large medical databases that contain a wealth of safety information. In addition, the agency will have the capacity to modernize its Adverse Events Reporting System used to collect and aggregate safety data, and better evaluate risk communication and risk management programs.

“Furthermore, the House PDUFA bill will enable the FDA to hire 27 additional employees to review drug advertisements prior to public dissemination, helping to ensure that benefits and risks are clearly and accurately communicated. It also will create strong incentives for companies to submit advertisements to the agency before airing them, in accordance with PhRMA’s Guiding Principles on Direct-to-Consumer Advertisements about Prescription Drugs.

“Currently, FDA review times for advertising submissions are long and unpredictable. We believe this bill, like the legislation passed by the Senate, will lead to more expeditious and predictable review times, which ultimately benefits public health.

“PhRMA looks forward to continuing to work in a bipartisan manner with Members of the House and Senate to further improve the legislation as it moves to conference."
 

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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 $43 billion in 2006 in discovering and developing new medicines. Industry-wide research and investment reached a record $55.2 billion in 2006.

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