So much for transparency! The long-awaited FDA guidelines for Park Doctrine executive prosecutions effectively shut out drugmakers from the agency's thinking on when jail time might drive compliance better than a consent decree or warning letter. And despite the regulator's highly visible transparency initiative, it took two Freedom of Information Act requests by law concern Ropes & Gray before the agency made the very general guidelines available at the beginning of the month.
The FDA Law Blog by Hyman, Phelps & McNamara notes that the criteria are "the same as those considered in any decision of whether to proceed criminally, misdemeanor or felony. They are hardly unique to this incredibly stringent strict liability standard against responsible corporate officials."
Park Doctrine prosecutions of drug company executives for repeat manufacturing or marketing violations are an enforcement tool the FDA has been promising to use.
As written, the guidelines stand in direct violation of FDA goals outlined in last month's Phase III transparency report: "FDA must clearly communicate standards and expectations to industry. Communicating requirements and expectations to industry in a more accessible manner promotes understanding of, and compliance with, rules set up to protect the supply of food and medical products."
Among the just-posted criteria: violations that "involve actual or potential harm to the public," "reflect a pattern of illegal behavior and/or failure to heed prior warnings," and similarly vague statements. The guideline includes no examples and states the criteria are non-binding.
As the blog points out, however, enforcement discretion "ultimately lies with the prosecutors, despite whether the criteria laid out by FDA are satisfied."