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Many drug studies not begun, FDA says

February 02, 2007|From Bloomberg News

WASHINGTON — Drug makers have yet to begin more than two out of every three pending studies that they promised to conduct after their products were approved by U.S. regulators.

The Food and Drug Administration determined that 899 of 1,259 post-approval studies hadn't been started as of Sept. 30, according to data posted Thursday on the agency's Website. The numbers do not include completed studies.

To receive FDA approval, drug makers often agree to perform additional studies of safety, dosing and other matters after medications come to market. Doctors say post-approval studies may be needed to fully assess the risks of medications because some dangers don't emerge until products are in widespread use.

Members of Congress have criticized the FDA's oversight of drug safety in recent years, as studies linked antidepressants to suicide risk for children and painkillers to elevated chances of heart attacks. Merck & Co. withdrew its Vioxx painkiller in 2004 after a company study showed higher heart attack and stroke risks.

Bloomberg News reported last year that FDA records on the status of some post-approval studies appeared incorrect. In other cases, drug makers failed to keep promises they made to do the research.

According to the FDA statistics released Thursday, 184 studies were on or ahead of schedule, and 144 had been submitted for FDA review or terminated. Thirty-one studies were labeled as "delayed."

The FDA didn't specify the number of drugs covered by the studies or over what time period the studies had been requested. Drug makers sometimes agree to complete multiple studies for a single product.

Not all of the uninitiated studies are considered late by the FDA. Many don't have deadlines imposed by regulators. The FDA and drug makers sometimes spend months discussing the design of the studies before they can begin.

The FDA's annual report on outstanding post-approval studies didn't identify specific companies.

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