HHS OIG Calls on FDA to Improve Post-Approval Tracking Studies

According to a report released last week by the HHS Office of Inspector General, the FDA does not adequately track the status of post-market studies that pharmaceutical companies have promised to conduct on new medications. According to the report, about 48% of applications for new medications approved by FDA from 1990 to 2004 involved at least one post-market study commitment. Pharmaceutical companies are expected to submit to FDA annual reports on the progress of post-market studies, but among the 336 reports due in 2004, 35% "were missing entirely or contained no information on open post-marketing study commitments," the report finds. In addition, the report finds that FDA validated only 30% of the reports submitted in 2004. The report recommends that FDA update systems used to track the status of post-market studies and ask pharmaceutical companies to submit more information. FDA officials disagreed that the agency does not adequately track the status of post-market studies and cited "the seriousness with which it takes the obligation to monitor" such studies, according to the report.