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November 27, 2009

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Editorial: Better rules approved for pediatric drug use

Tuesday, Dec. 1, 1998 | 11:42 a.m.

Testing a new drug's effect solely on adults, without similar tests on children, can lead to disastrous outcomes. In a New York Times story last week, FDA officials noted that many infants died of "gray baby syndrome" in the 1950s because an antibiotic wasn't adequately tested in children. More recently, there have been problems with AIDS drugs, some of which weren't tested in children. Some drug companies went back and did the testing in children to determine the right dosages only after the AIDS drugs had already been approved.

The new FDA rules do permit drug companies the necessary flexibility to defer testing in children for safety reasons. For example, the FDA may allow a drug manufacturer to postpone testing in children until the new drug is found to be safe and effective for adults. And the testing could be waived if pediatric studies are highly impractical, impossible or the drug itself unlikely would be used by children.

It is crucial that physicians have better information so that drugs are properly prescribed. The FDA has established sound testing regulations while also putting in place safeguards so the testing that is done in children will be safe and reasonable.

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