WLF Cautions FDA Regarding Park Doctrine

By Peter M. Jaensch –

Over the last seven months, officials at FDA, including the FDA Commissioner, Margaret Hamburg, MD, and the Deputy Chief Counsel for Litigation, Eric Blumberg, have been promising to resume use of the individual criminal liability doctrine known as the Park Doctrine (also known as the Responsible Corporate Officer Doctrine).  If this occurs, it would increase the stakes for alleged violations of the Federal Food, Drug, and Cosmetic Act.  Because FDA appears to believe that fines, penalties, and other money payments have not deterred certain conduct, it  now seems to believe that individual criminal liability for corporate officers will be a better deterrent.  We have earlier written several pieces on this subject (here, here, and here among others).

On October 26, 2010, the Washington Legal Foundation (“WLF”) sent a letter to FDA.  WLF calls on FDA to abandon its plans to seek criminal sanctions under Park for company executives for promotional activities in instances where the executives never participated in, encouraged, or had knowledge of the alleged violations.