Developments in FDA oversight of its Office of Criminal Investigations

by Ben Vernia | March 21st, 2010

The Food and Drug Administration’s Office of Criminal Investigations (OCI) conducts criminal investigations, primarily of the Food, Drug, and Cosmetic Act. In the era of massive pharmaceutical investigations and settlements, the FDA-OCI plays a central role in many of the government’s biggest cases.

On March 4, the Government Accountability Office released a January, 2010 report issued to Sen. Charles Grassley (R-IA), concerning the FDA’s oversight of the operations of OCI. Among the GAO’s critiques:

  • FDA has policies for overseeing investigations of OCI, but fails to implement them;
  • FDA has failed to perform periodic evaluations of field offices on a timely basis;
  • FDA could implement measurements of performance that would enhance its oversight.

On the same day, the FDA issued a letter to Sen. Grassley defending its oversight, stating that an FDA committee made several recommendations which it intended to implement, including new policies for increased use of misdemeanor prosecutions.

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