FDA comes under fire from prestigious medical journal.

Publication: Knight Ridder Washington Bureau (Washington) (via Knight-Ridder/Tribune Business News)

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COPYRIGHT 2004 Knight Ridder Washington Bureau

Byline: Tony Pugh

Nov. 23--WASHINGTON -- Drug maker Bayer was slow to report the risks of its cholesterol-lowering drug Baycol and to remove it from the market in 2001, according to a forthcoming report in the Journal of the American Medical Association.

The findings, based in part on internal company documents revealed in a recent court case, raise new questions about the Food and Drug Administration's effectiveness in monitoring the safety of drugs after it has approved them for sale.

The report on Baycol appears in the journal's Dec. 1 issue, along with five other papers on problems with drugs after they have been approved for sale. An accompanying editorial in the influential journal recommends that a new federal regulatory office be established, independent of the FDA, to monitor drugs once they are on the market.

The Baycol study concluded that Bayer officials knew...

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