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PhRMA Statement on PDUFA Reauthorization Proposals

WASHINGTON, January 11, 2007 — Pharmaceutical Research and Manufacturers of America (PhRMA) President & CEO Billy Tauzin issued the following statement today on the new PDUFA reauthorization proposals submitted to Congress:

"The PDUFA proposals from America's pharmaceutical research companies and the Food and Drug Administration call for comprehensive improvements in all areas that are essential to timely safe and effective use of new medicines by millions of American patients. Pharmaceutical research companies and the FDA are proposing to Congress new funds for improving drug development, drug safety and the information technology system within the agency.

"And in an important new step, the PDUFA proposal also includes a user fee program to hire more agency personnel to facilitate review of new direct-to-consumer advertising in advance of it being aired on television. The FDA would have more resources to develop comments for companies before their ads are broadcast, which would help to ensure the advertising's accuracy, balance and compliance with all regulatory requirements.

"In the key area of drug safety, funding would be provided to bring the FDA drug safety system into the 21st Century. The agency's Office of Surveillance and Epidemiology (previously known as the Office of Drug Safety) would receive additional safety officers, new information management systems and improved access to drug safety data bases.

"An essential feature of the industry/FDA PDUFA drug safety proposals is development of a five-year plan that explains how additional safety money would be used to help reduce dependence on less reliable spontaneous reporting of adverse drug reactions. The FDA would also develop detailed guidance on the best epidemiology practices that could be used by everyone, including agency officials, academia and industry. The guidance would allow all drug risk reports to be based on uniform scientific standards.

"In the drug development arena, new funding for the FDA's Critical Path Initiative for more efficient drug development would allow FDA staffers to participate in partnerships with outside experts. This would help them to generate the information needed to create innovative new drug development approaches. The FDA would provide comprehensive guidance to biomedical researchers in seven key areas of drug development, including clinical trial design.

"Additionally, more user fee money would be devoted to improving the FDA's information technology infrastructure so the agency is better prepared to receive and review electronic drug applications. The new funds would continue an important improvement effort begun 10 years ago during an earlier PDUFA reauthorization. Reviewing data electronically helps to improve the efficiency of the drug approval process and expedites getting important new drugs to the patients who need them.

"In the end, America's pharmaceutical research companies and the FDA have recommended a wide array of proposals, all of which are designed to make sure millions of patients continue to receive safe and effective medicines in a timely manner. The proposals are also designed to make sure new drugs, once they're on the market, continue to offer safe and effective therapy throughout their shelf life. We must be able to gauge whether benefits continue to outweigh risks once medicines are available to the general patient population."

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 $39.4 billion in 2005 in discovering and developing new medicines. Industry-wide research and investment reached a record $51.3 billion in 2005.


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Contact: Jeff Trewhitt (202) 835-3460

Posted: January 2007