For most executives of FDA-regulated life sciences firms, their main focus understandably is securing approval of drugs, biologics, and medical devices vital not only to serve patients, but also bottom lines. Sometimes -- hopefully rarely -- life sciences executives lose sight of their commitment to full compliance with FDA legal and regulatory requirements. When that occurs, they expose their companies and themselves personally to a panoply of potential enforcement remedies in FDA's armamentarium.

While the agency prefers to secure voluntary compliance, executives must not lose sight of the fact that, under the Federal Food, Drug, and Cosmetic Act ("the Act"), FDA, working with the Department of Justice, has the discretion to pursue criminal charges against responsible corporate officials for legal/regulatory violations that occurred "on their watch" even if the official did not know of the violation or intend for it to occur. Commonly referred to in FDA circles as the "Park Doctrine," this theory of strict criminal liability gives FDA a powerful tool to both punish offense and deter future violations by others.

In recent years, however, a perhaps equally powerful new enforcement weapon has been wielded by the federal government against individuals involved in FDA legal violations -- exclusion from participating in federal healthcare plans. Most publicly manifested in a 2012 federal circuit court decision upholding the exclusion of three former senior executives of Purdue Pharma, exclusion renders unemployable any executive caught in its crosshairs, even if convicted of a misdemeanor for an "unknowing" Park Doctrine criminal violation of the Act.

For more information on the Park Doctrine and HHS exclusion, please refer to our Client Alert of August 2012, entitled, D.C. Circuit Affirms HHS Power to Disqualify Corporate Officials Convicted of Misdemeanors Under the "Responsible Corporate Official" (RCO) Doctrine ( click here for Alert).

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