FDA Publicly Releases Guidelines for Park Prosecutions Following FOIA Appeals


The Food and Drug Administration (FDA) advised Ropes & Gray today that it has published its criteria for Park doctrine prosecutions of responsible corporate officers in its Regulatory Procedures Manual. Under United States v. Park, a corporate official may be convicted of a misdemeanor violation of the Food Drug and Cosmetic Act (FDCA) without personally engaging in wrongdoing, or even knowing about another person’s violation of the statute, provided the official had the responsibility or authority to prevent or correct the FDCA violation but failed to do so.

FDA announced its intent to push for increased use of criminal misdemeanor prosecutions of responsible corporate officials in a letter to Senator Charles Grassley (R-IA) released on March 4 of last year, but, until now, has declined to make available the criteria and procedures it had adopted to drive the selection of these prosecutions.

In the “non-binding” criteria that it has now released, FDA confirms that knowledge of and actual participation in the violation are not a prerequisite to prosecution, though they are relevant facts when deciding whether to recommend charging an individual, and that a misdemeanor conviction of an individual may serve as the basis for debarment by FDA. Notably absent from FDA’s criteria is any consideration of efforts by the corporate official or the corporation to prevent and detect the type of misconduct that occurred.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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