FDA criticized for slow pace of pediatric studies

08:27 PM ET 10/07/98

WASHINGTON (Reuters) - Lawmakers on Wednesday criticized theU.S. Food and Drug Administration (FDA) for being slow to carryout pediatric studies of already approved drugs. The FDA Modernization Act of 1997 required the agency to notify pharmaceutical companies if their existing products needed additional testing. According to the Pharmaceutical Research and Manufacturersof America (PhRMA), the FDA has only asked for pediatric studies for five drugs out of hundreds eligible. ``What's causing the delay?'' asked Virginian Republican Rep. Tom Bliley, chairman of the House Commerce Committee. FDA officials said the issue was complex and it had, infact, issued requests for eight studies and was readying requests for nine more. ``It's not simply a matter of asking a company to do a study,'' FDA deputy commissioner William Schultz told a Commerce Committee hearing. ``We have to figure out what studies are necessary.'' In May, the agency published a list of hundreds of existing drugs that might require additional testing, and could receive six months more patent life if they met FDA standards. But, companies will only be eligible after FDA has asked for more data, a requirement that irritates drug makers. ``This functionally penalizes a company which has gone ahead in good faith with pediatric studies in anticipation of a request from FDA,'' said Stephen Spielberg, global head ofpediatric research at the R.W. Johnson Pharmaceutical Research Institute. California Democrat Henry Waxman objected to FDA ranking the research requests according to patent expiry. Those drugs whose patents expire before March 31, 1999 are being targeted first,said PhRMA president Alan Holmer. ``It seems like more priority should be given to those drugs that save childrens' lives,'' said Waxman.

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