Corporate executives have rarely been personal targets of FDA enforcement actions. As such, the risk of personal liability may seem more theoretical than real to business leaders. However, recent pronouncements from FDA indicate that this risk of personal liability may become more of a reality.

In a letter to Senator Charles Grassley (R-Iowa) on March 4, 2010, FDA announced several new initiatives that will likely result in more, and more specifically targeted, criminal prosecutions of corporate officials and clinical investigators. View the letter here. The announcement came in response to a report issued by the Government Accountability Office on FDA's oversight of its own Office of Criminal Investigations (OCI), the FDA office that investigates potentially criminal activity of regulated companies and individuals. View the report here. Senator Grassley requested that GAO conduct the investigation because of concerns about the way OCI handled the Ketek investigation. Essentially, Senator Grassley has become increasingly concerned that FDA is not doing enough to enforce the law, including not doing enough to hold corporate executives responsible.

The GAO report recommended that FDA establish procedures for assessing how well OCI complies with established investigative policies and use those procedures to regularly assess OCI's compliance with those investigative policies. The report also recommended that FDA establish performance measures for OCI and assess program results against those performance measures.

FDA's letter accepted these fairly mundane recommendations from GAO and went on to use this as an opportunity to discuss other more significant measures it is taking on its own initiative. In part, this letter is intended to be a strong message to business. Specifically, FDA said that it intends to increase "appropriate" use of misdemeanor prosecutions to hold corporate officials responsible. According to FDA's letter, criteria have already been developed for consideration in selection of misdemeanor prosecution cases and will be incorporated into policies and procedures.

To further implement this policy:

1.FDA intends to increase information sharing between OCI and other agency components with the goal of aligning criminal and regulatory priorities and activities. In this way, OCI will be aware of FDA Center concerns about emerging risks, regulatory policies and priorities, and prioritize its own investigative activities accordingly. At the same time, with additional information flow from OCI to the Centers, Centers will be able to develop more effective regulatory policies.

2.FDA intends to strengthen mechanisms used to ensure that senior leaders share information and coordinate strategic priorities to align criminal enforcement and regulatory activities.

3.FDA intends to enhance its procedures supporting debarment and disqualification actions, and clarify when these administrative actions may proceed concurrently with pending criminal investigations and prosecutions.

Bottom line: This is another step in FDA's increasingly tight enforcement approach. FDA will increase targeting of corporate executives. Greater coordination and information sharing between OCI and FDA Centers will likely result in more investigations and prosecutions arising out of the clinical trial and premarket review processes. Corporate officials as well as clinical investigators will feel the brunt of this increased scrutiny.