Author: Mary Holloway
One big question arises when considering the implications of the Park Doctrine: what factors will the government consider in selecting misdemeanor prosecution cases? The FDA released their answer last month. Its Regulatory Procedures Manual asserts that when considering misdemeanor prosecution against “a corporate official,” the individual’s position, relationship to the violation, and whether they could have prevented it are relevant issues. The following criteria are also listed as considerations.
Whether the violation:
- Involves actual or potential harm to the public
- Is obvious
- Reflects a pattern of illegal behavior and/or failure to heed prior warnings
- Is widespread
- Is serious
And whether the:
- Quality of the legal and factual support for the proposed prosecution
- Proposed prosecution is a prudent use of agency resources
Of prime concern is the fact that these criteria are non-binding! The manual states that the criteria:
- “Do not create or confer any rights or benefits for or on any person”
- “Do not operate to bind FDA”
- “Further, the absence of some factors does not mean that a referral is inappropriate where other factors are evidence.”
The FDA does not provide any clarification on what defines a position of authority, nor do they define what kind of behavior they would consider violative. That being said, the responsibility for how to proceed rests more with the Department of Justice than with the FDA.
However, for those of us in the Life Sciences industry, our next step is clear: ensure that all individuals in your organization understand what constitutes violative behavior in the eyes of the government. And certainly don’t rely on these purported criteria which create a highly subjective road map.
Note: The Park Doctrine stems from a Supreme Court ruling in the 1975 case of U.S. v. Park. It states that an individual can be convicted of a misdemeanor simply because they were in a position of authority and thus had an ability to prevent or correct an FDCA violation. This doctrine does not require proof that the executive did anything wrong or was even aware that the violative action occurred.