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<?xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" />Washington, D.C., July 24, 2003—The U.S. Senate yesterday approved a measure that would allow the Food and Drug Administration to require many drugs developed for adults to also be tested on children as a condition for their approval. The bill is a legislative replacement for an FDA regulation – known the Pediatric Rule – that was struck down in last year when a federal court ruled that the rule exceeded FDA’s authority. The suit had been brought by the Competitive Enterprise Institute, the Association of American Physicians and Surgeons, and Consumer Alert.<?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" />
Under the bill, FDA could demand that drug manufacturers perform pediatric testing on adult drugs that are used “off-label” for children. Even though a drug may be labeled for use by adults only, it would have to be tested on children if there was a likelihood that pediatricians would use it. The groups opposing the bill argue that it would add yet another obstacle to the already lengthy drug approval process, and would involve FDA in regulating the actual practice of medicine.
“While this bill is couched in terms of protecting children, if enacted it would be a public health setback,” said Sam Kazman, CEI General Counsel. “It would delay new drug development, endanger the very concept of off-label use, and create health risks for parents and children alike.”
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