FDA Asked to Improve Oversight of Drug Studies

Joe Saunders

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The Department of Health and Human Services has issued a plea to the FDA to tighten its monitoring of promised studies by drug companies. According to a Wall St. Journal story, "The Food and Drug Administration doesn't know the status of many postapproval studies promised by drug makers and doesn't make tracking them a top priority, a report released Friday said.The inspector general at the Department of Health and Human Services said the FDA should improve its monitoring of the studies by upgrading its tracking systems and asking manufacturers to provide better information."

Companies are supposed to give the FDA annual reports on the progress of their studies. The inspector general said 35% of 336 annual reports due in 2004 "were missing entirely or contained no information on open postmarketing study commitments." The FDA validated only 30% of the reports, the report said.