Washington, D.C. (May 15, 2008) — Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson issued the following statement today regarding increased Congressional appropriations for the FDA:

“A strong, well-funded Food and Drug Administration (FDA) is critical to the health and safety of the American public. The agency is charged with helping to assure the safety, effectiveness and availability of medicines taken by millions while helping to ensure Americans continue to have access to innovative new therapies.

“To this end, PhRMA applauds the decisionof U.S. Senators Herb Kohl and Robert C. Byrd to bolster Congressional appropriations to the agency in the supplemental appropriations bill.

“Since 1992, industry user fees have been a resounding success for the FDA, America’s pharmaceutical research companies, taxpayers and, most importantly, patients. By charging user fees, the FDA has been afforded the resources and additional staffing that enabled the agency to review new medicines more efficiently, while maintaining its stringent safety and efficacy standards.

“While PhRMA and its member companies have significant experience with this successful user fee program, we believe it is in the best interest of the public health and safety for Congress to significantly increase appropriated resources to help the FDA realistically fulfill its regulatory obligations in a timely manner, in keeping with the agency’s public health mission.

“The U.S. regulatory system for prescription drugs already is one the toughest and safest in the world. But, while the FDA’s regulatory responsibilities have increased dramatically, its financial resources have not. This disparity has been highlighted by the FDA’s own Science Board.

“Indeed, at least one member of the FDA’s Science Board subcommittee called for doubling FDA’s Congressional appropriations to contend with the agency’s growing responsibility, compared with its current resources.

“Overall, the Fiscal Year 2008 Emergency Supplemental legislation considered by the U.S. Senate will preserve – and even strengthen – the FDA’s ability to do its job. The $275 million funding boost under consideration would increase the agency’s budget for medical product and drug safety activities by $100 million. Patients will benefit from 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.”

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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 $44.5 billion in 2007 in discovering and developing new medicines. Industry-wide research and investment reached a record $58.8 billion in 2007.

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