More Than a Third of Drug Safety Reports Missing in Action
July 29 2006
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According to a report by the inspector general of the Department of Health and Human Services, the U.S. FDA has not made tracking post-approval drug studies a priority, and does not know the status of many of them.
Roughly half of all drug approvals involve a commitment by the manufacturer to at least one post-approval study commitment.
Companies are required to give the FDA annual progress reports on these studies, but 35 percent of the reports due in 2004 were either missing entirely or contained no relevant information. The FDA validated less than a third of the reports. The FDA has little to no power to punish drug companies that leave such studies unfinished.
The inspector general said the FDA should improve its monitoring of the studies, upgrade its tracking system, and ask manufacturers to provide better information.