PhRMA Statement on Enactment of FDA Legislation

Washington, D.C. (September 27, 2007) — Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO Billy Tauzin issued the following statement today on the enactment of the “Food and Drug Administration Amendments Act of 2007”:

“By signing into law the ‘Food and Drug Administration Amendments Act,’ President Bush has taken a vital step to both strengthen our nation’s drug safety system – already the world’s best – and preserve crucial incentives to help spur research and generate critical information about the use of medicines in our children.

“The law, which reauthorizes the Prescription Drug User Fee Act (PDUFA), provides FDA with additional resources it needs to promote and protect the public health. The increased fees will allow the agency to expand drug safety monitoring, hire additional staff for post-market surveillance, and modernize its information technology systems.

“FDA will have the capacity to modernize its Adverse Events Reporting System, which is used to collect and aggregate safety data, enhance its use of epidemiology studies and large medical databases that contain a wealth of safety information, and better evaluate risk communication and risk management programs.

“The law also reauthorizes the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA), both of which were set to expire on September 30. BPCA has done more to spur research and generate essential information about the use of medicines in pediatric patients than any other initiative and PhRMA has supported its reauthorization without significant modifications.

“Furthermore, the law will enable FDA to hire additional employees to review broadcast 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 such advertisements to the agency before airing them. This will complement improvements in advertisements that have already occurred as a result of PhRMA’s Guiding Principles on Direct-to-Consumer Advertisements about Prescription Drugs.

“Since its original enactment in 1992, PDUFA has been a resounding success for FDA, pharmaceutical research companies, taxpayers and, most importantly, patients. PDUFA has made timely review of new medicines possible without compromising FDA’s strict and objective review process. As a result, more than 1,000 new medicines have been made available to patients over the past 15 years. These medicines have helped millions of people lead healthier, more productive lives, and contributed to a longer life expectancy than ever before.”
 

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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.

PhRMA Internet Address: www.phrma.org

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

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

For information on the danger of imported drugs, visit: www.buysafedrugs.info