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Food and Drug Administration: HHS Inspector General Should Be Involved in Criminal Investigations

HRD-88-8 Published: Nov 04, 1987. Publicly Released: Nov 04, 1987.
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Highlights

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.

Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
Department of Health and Human Services 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.
Closed – Implemented
The Secretary, HHS, delegated Food, Drug and Cosmetic Act criminal investigation authority and responsibility to the Inspector General, HHS, as of July 24, 1989.

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Topics

DrugsFood and drug lawInspectionInspectors generalInvestigations by federal agenciesLaw enforcementPharmaceutical industryProposed legislationRegulatory agenciesForgery