FDA Spells Out Criteria for Pursuing Criminal Cases

Drugmakers nervous about seeing their executives targeted for criminal prosecution under the FDA’s stepped-up enforcement campaign based on the Park doctrine have received some insight into the factors the agency considers when pursuing such cases. In Chapter 6 of the FDA’s Regulatory Procedures Manual, the Office of Criminal Investigations tells its district offices that if they are considering pursuing a case using the Park doctrine they should first determine whether the violation in question involves actual or potential harm to the public, as well as laying out other criteria.
Washington Drug Letter