FDA flubs off-label enforcement

The FDA takes too long to warn a pharmaceutical company about off-label promotion, according to a Government Accountability Office (GAO)

According to the GAO, the FDA:
  • Takes an average of seven months to warn a company about possible violations
  • Is unable to review all submissions because of the volume of materials it receives
  • Prioritizes reviews to examine those with the greatest potential impact on human health
  • Relies on staff to sort though large volumes of material and prioritize them for review
  • Is hampered by the lack of a system that consistently tracks the receipt and review of submitted materials

Between 2003 and 2007, the FDA issued 42 letters requesting companies stop marketing products for off-label uses, but did not refer any of the violations to the Department of Justice (DOJ) for enforcement actions. During the same time, the DOJ settled 11 civil and criminal cases that involved off-label marketing to some extent.

Senator Charles Grassley (R-IA) requested the review.
Source: ePharmaceuticals

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