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OIG study highlights pharma, FDA post-market study failures

Pharma Compliance Alert, July 12, 2006

Pharmas may see increased scrutiny as the result of a study that finds they often fail to fulfill their commitments for post-marketing studies. The HHS Inspector General report also found that the FDA's system for managing the studies is ineffective. The report showed that 35% of the annual status reports (ASR) that pharmas should have submitted in fiscal year 2004 as part of their post-marketing study commitments were missing or incomplete. However, the FDA has "limited recourse" when companies don't submit their ASRs, the report found. The report also says the FDA cannot readily identify the progress that companies are making with their studies.

The Inspector General says the FDA should instruct companies to provide additional meaningful information in their ASRs, improve the management information system for monitoring post-marketing study commitments, and ensure that post-marketing study commitments are being monitored and ASRs are being validated. Read the report on the HHS Inspector General's Web site.

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