Food and Drug Administration:

HHS Inspector General Should Be Involved in Criminal Investigations

HRD-88-8: Published: Nov 4, 1987. Publicly Released: Nov 4, 1987.

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In response to a congressional request, GAO discussed: (1) the Food and Drug Administration's (FDA) and the Department of Health and Human Services' (HHS) Inspector General's (IG) authority to conduct criminal investigations relating to: (1) counterfeit and diverted drugs; and (2) training and resources available to conduct such investigations.

GAO found that: (1) the Food, Drug and Cosmetic Act authorizes FDA to conduct inspections which could result in the discovery of a criminal act; (2) because FDA seeks specialized criminal investigative skills from other federal agencies, it does not train its personnel for criminal investigations; (3) proposed legislation could increase FDA involvement in criminal investigations; and (4) IG believes that it should conduct criminal investigations for FDA, as it does for other HHS agencies, since it currently has the resources.

Recommendation for Executive Action

  1. Status: Closed - Implemented

    Comments: The Secretary, HHS, delegated Food, Drug and Cosmetic Act criminal investigation authority and responsibility to the Inspector General, HHS, as of July 24, 1989.

    Recommendation: The Secretary of Health and Human Services should direct the Commissioner, FDA, and HHS IG to develop and implement a plan for involving IG in FDA criminal investigations of its regulatory programs. Such a plan should identify the types of FDA investigations that will be referred to IG, when such referrals should be made, and the specific responsibilities of FDA and IG in carrying out criminal investigations.

    Agency Affected: Department of Health and Human Services


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