James S. Cohen, a shareholder in the Food and Drug Section of Buchanan Ingersoll & Rooney's Washington, D.C., office, was quoted in an FDAnews Devices & Diagnostics Newsletter article about the Government Accountability Office (GAO) report that was released on March 4. The article, titled "Company Officials May Be Held Liable as FDA Steps Up Its Prosecutions," discussed the FDA's plans to increase prosecutions against corporate officials as part of its drive to improve its Office of Criminal Investigations (OCI).
According to the article, "the GAO report said OCI should be given measurable performance goals and undergo regular monitoring instead of being left alone to determine what to report about its investigations. The report recommends the FDA conduct regular assessments of the main and field offices."
The GAO report also indicated that of the 24 OCI field office assessments that should have been completed by August 2009, only 30 percent were completed.
The article noted that FDA Commissioner Margaret Hamburg, in a letter sent last week to Sen. Chuck Grassley (R-Iowa), who had requested the GAO report, indicated the agency would take a further step and pursue prosecutions, potentially using the legal concept of strict liability.
As a former senior official at the FDA, Cohen was asked to weigh in and explained, "That could have a serious impact on FDA-regulated companies. It means that, under U.S. Supreme Court case law, company executives can be held liable for company wrongdoing even if they were not aware of the wrongdoing.”
These corporate officers have a positive duty to seek out and remedy violations and to implement measures that will ensure that violations will not occur,” Cohen added.
He further explained that increased OCI oversight could mean more input and involvement by CDRH into the type of conduct and cases to investigate.
“Between this initiative and the increased focus of the Department of Justice on device marketing practices, this could result in a significant increase in device enforcement activity,” Cohen added.