PhRMA Statement on the Approval of New Medicines

Washington, D.C. (April 22, 2008) — Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson issued the following statement today on the safety and effectiveness of medicines approved for patient use:

"The drug approval requirements of the Food and Drug Administration are the gold standard of the world and the United States has one of the strongest drug safety records. But all medicines have potential side effects and despite our rigorous drug approval process, adverse reactions are sometimes not detected until a medicine has been approved and made available to an entire patient population. That's why the post-market surveillance requirements of the FDA are so vitally important.

"The drug approval process in the United States typically spans 10 to 15 years and includes up to seven years of extensive clinical testing in thousands of volunteer patients. And most of the time, America's pharmaceutical research companies are able to identify potential side effects and the FDA is able to determine if the benefits of a medicine outweigh its risks. The information is thoroughly summarized on a treatment's product label.

"Because side effects are sometimes not detected until after a medicine has been approved for general patient use, pharmaceutical research companies must continue to submit periodic reports to the FDA, including appropriate quality-control records and any new cases of adverse reactions. For some medications, regulators require clinical testing after the products have been marketed to evaluate long-term effects.

"What's more, the FDA now has new authority provided by the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require additional post-market studies and changes to product labeling. In addition, the FDAAA, through approved user fees, gives the agency significantly increased funds for drug safety activities.

"In the end, America's drug approval process and post-market surveillance system have been overwhelmingly successful in making sure that patients receive medicines that are safe and effective and able to treat or prevent a wide array of diseases and medical conditions."

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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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