To a regulatory and compliance professional, FDA citations are a part of the landscape. Granted, no one welcomes such a situation, but ensuring regulatory compliance is the core of what we do on a daily basis. While the foundation of compliance requirements within our profession is black and white, in terms of how we must proceed with developing a regulatory strategy and employing risk management, much of what we bring to the table is in the gray zone. So the FDA’s distinct shift to flexing its enforcement muscles should be central to any regulatory and compliance strategy under discussion today.

Earlier this year the FDA made its new philosophy on enforcement clear when it announced its intention to push for an increase in the use of criminal misdemeanor prosecutions of “responsible corporate officials.”¹ This change in enforcement policy means that executives in the pharmaceutical, medical device, and other FDA-regulated industries may be targeted for criminal charges under the Food, Drug, and Cosmetic Act (FDCA).

Two landmark U.S. Supreme Court cases underlie this new position, United States v. Dotterweich and United States v. Park. As a result of these two cases, a corporate official can be convicted of a misdemeanor violation of the FDCA without personally engaging in wrong doing, 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.

Senior management accountability has always been the cornerstone of a well-designed pharmaceutical Quality Management System (QMS). At a minimum, the lead quality professional was always held accountable for the quality practices of the organization, but fully compliant QMS’ are able to demonstrate a broad level of accountability across the organization. However, this new doctrine by FDA departs from standard principles of criminal law by imposing strict criminal liability on a person who has neither engaged in misconduct nor exhibited criminal intent. Under this new philosophy executives convicted of misdemeanor violations of the FDCA can face imprisonment and substantial fines.

The driver behind such a public shift in dogma by the FDA Commissioner may be a critical internal report by the Government Accountability Office that criticized the FDA’s oversight of their Office of Criminal Investigations. The Commissioner further indicated that senior leadership within the FDA had recommended that the agency “increase the appropriate use of misdemeanor prosecutions, as a valuable enforcement tool, to hold responsible corporate officials accountable.”