FDA deputy chief for litigation Eric Blumberg gave a speech reiterating agency interest in targeting pharma execs. These moves also come as the Health and Human Services Office of Inspector General pushes for measures to make it possible to ban pharma execs from doing business with federal health programs, if their companies have been convicted of fraud.
The FDA plan, though, has been to use the Park doctrine, which says a corporate official can be convicted of a misdemeanor based solely on his or her position of responsibility and ability to prevent underlying violations of the Food, Drug & Cosmetic Act. The doctrine also stipulates there is no requirement that an exec acted personally in any wrongdoing, or had knowledge of the wrongdoing.
FDA have now released the criteria - whether the violation involves actual or potential harm to the public; whether the violation is obvious; whether the violation reflects a pattern of illegal behavior and/or failure to heed prior warnings; whether the violation is widespread and/or serious; the quality of legal and factual support for the proposed prosecution; and whether the proposed prosecution is a prudent use of FDA resources
The FDA plan, though, has been to use the Park doctrine, which says a corporate official can be convicted of a misdemeanor based solely on his or her position of responsibility and ability to prevent underlying violations of the Food, Drug & Cosmetic Act. The doctrine also stipulates there is no requirement that an exec acted personally in any wrongdoing, or had knowledge of the wrongdoing.
FDA have now released the criteria - whether the violation involves actual or potential harm to the public; whether the violation is obvious; whether the violation reflects a pattern of illegal behavior and/or failure to heed prior warnings; whether the violation is widespread and/or serious; the quality of legal and factual support for the proposed prosecution; and whether the proposed prosecution is a prudent use of FDA resources