FDA's chief litigator said he is focusing on corporate chief executives for personal prosecution in cases of flagrant off-label product promotions. Agency deputy chief counsel for litigation Eric M. Blumberg told a Food & Drug Law Institute Enforcement and Litigation Conference in October that this area if a top priority under a rejuvenated strategy using the Park Doctrine, which holds CEOs liable even when they knew nothing about the offenses.
Since 1999, Blumberg said, the government has filed 27 civil and criminal cases involving off-label promotion against pharma and device companies, leading to several billion dollars in settlements, and yet the activity “continues virtually unabated.”
While sharing his own views on misdemeanor prosecutions, Blumberg said it would be “futile” to establish a checklist rigidly listing the circumstances when FDA would, or would not, bring a Park-type strict liability case “because the facts are too varied.” A checklist approach, he continued, would also likely be “counterproductive,” because as soon as FDA developed a list, corporate executives would be developing strategies to get around it.
However, Blumberg did outline the “types of facts” that the agency has traditionally examined to determine whether a criminal case should be brought and, if so, whether one or more individuals should be charged.