By Lauren A. Tulli
Recently, the FDA released guidelines titled the “Special Procedures and Considerations for Park Doctrine Prosecutions” to clarify the mechanism by which enforcement actions can be brought against corporate executives of FDA regulated companies. Although the guidelines are non-binding, they illustrate the government’s apparent commitment to punish corporate executives as individuals, for violations of the Food Drug and Cosmetic Act (FDCA).
The threat of criminal enforcement is not new. In United States v. Park, 421 U.S. 658 (1975), the Supreme Court affirmed a criminal conviction of a company officer for regulatory violations in a food storage facility. The defendant denied he had any knowledge of the conditions, but the Court held that liability under the enforcement statute (21 U.S.C. § 331(a)) did not require a showing of knowledge or participation in the violation.
The “responsible corporate officer doctrine,” also known as the Park doctrine following this 1975 case, permits charges against high ranking individuals for violations of the FDCA. A corporate official may be convicted of a violation without engaging in any wrongdoing or knowledge of the violation, provided that the official had the authority or ability to prevent or correct the violation and failed to do so.
Penalties can be significant, including criminal fines, debarment by the FDA, and exclusion from participation in health care programs. Exclusion from participation in those federal programs can cripple a company.
The FDA’s new guidelines provide for the uniform submission and review of prosecution recommendations. They set forth several criteria to consider when deciding whether to recommend a Park prosecution against a corporate official, including the official’s position with the company, her knowledge of and relationship to the violation, whether she had the ability to prevent or correct the violation, and whether the violation is serious, widespread and causes actual or potential harm to the public.
Last year, Eric Blumberg, FDA litigation chief, told an audience at a Food and Drug Law Institute event that the agency is looking for cases to employ the Park doctrine, in an effort to “change the corporate culture” of companies that have successfully avoided penalties thus far. He indicated that one area the agency will target is off-label marketing. “I don’t know when, where, or how many cases will be brought,” Blumberg advised, “but if you are a corporate executive – or counsel advising such a client – I would not wait for the first case to decide now is the time to comply with the law. They won’t get a mulligan on their conduct.”
The best course of action is to create a compliance program which identifies, addresses and corrects potential violations before they occur. Areas such as clinical trials and off-label marketing are particularly susceptible. By adopting a culture of compliance, companies may significantly reduce the risks that could find the company, and now, more than ever, the corporate officials, in trouble with the government.