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<?xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" />Washington, D.C., November 20, 2003—The U.S. House of Representatives yesterday approved a measure that would allow the Food and Drug Administration to impose pediatric testing requirements on many drugs developed for adults. The bill is a legislative replacement for an FDA regulation – known as the Pediatric Rule – that was struck down last year when a federal court ruled that it exceeded FDA’s authority. The suit had been brought by the Competitive Enterprise Institute, the Association of American Physicians and Surgeons, and Consumer Alert.
“Despite its claim of protecting children, this bill is bad medicine. It will delay the development of new drugs by making the drug approval process even longer and costlier than it already is, and it will endanger the very concept of off-label use. The result will be new health risks for parents and children alike,” said Sam Kazman, General Counsel of the Competitive Enterprise Institute. “At a time when the FDA’s overcaution already puts lives in danger, the last thing we need is another roadblock to new medicines.”
Under the bill, FDA could go so far as to remove an already-approved adult drug if a company declined to conduct pediatric testing, even if the company was not marketing the drug for use by children.
In a 2002 poll commissioned by CEI (http://www.cei.org/gencon/003,02985.cfm ), almost two-thirds (61 percent) of oncologists believed that the FDA was too slow in approving new medical drugs and devices. This was consistent with four previous CEI polls of medical specialists regarding their views of FDA.