Committee Wants Answers on FDA Office of Criminal Investigations

The House Committee on Energy and Commerce is examining the FDA’s Office of Criminal Investigations (OCI) over a variety of case management concerns.

The committee has sent a letter to FDA Commissioner Robert Califf after two separate investigations cited OCI management issues. The letter contains 11 questions covering how the FDA has addressed the concerns found in each investigation; existing policies for assessments; and the specifics of the assessment process.

A 2010 Government Accountability Office report on the OCI said the FDA maintained limited oversight of OCI investigations and had insufficient performance measures. Additionally, the investigation raised concerns about utilizing criminal law enforcement agents for non-criminal investigations, most of which were administrative in nature or resulted in administrative actions.