FDA Finally Releases “Non-binding” Park Doctrine Criteria

By Anne K. Walsh –

Eleven months after telling Senator Grassley (in a letter available here) that “[c]riteria now have been developed for consideration in selection of misdemeanor prosecution cases and will be incorporated into the revised policies and procedures that cover appropriate use of misdemeanor prosecutions,” FDA just last week finally released those criteria.  The idea behind such criteria is to increase misdemeanor prosecutions against corporate officials under the Park doctrine. 

As the amount of penalties paid by corporations for violations of the Federal Food, Drug, and Cosmetic Act ("FDCA") has increased, there has been a corresponding increased focus on deterring continued violations by holding individuals responsible.  Under the theory derived from the U.S. Supreme Court case of United States v. Park, 421 U.S. 658 (1975), a progeny of United States v. Dotterweich, 320 U.S. 277 (1943), a corporate official can be convicted of a misdemeanor based solely on his position of responsibility and control to prevent the underlying violation of the FDCA.  There is no requirement that the official acted personally in the wrongdoing, or that he even had knowledge of it.  The Supreme Court determined that the FDCA “imposes not only a positive duty to seek out and remedy violations when they occur but also, and primarily, a duty to implement measures that will insure that violations will not occur.”  Park, 421 U.S. at 672.

While we are grateful to finally have a glimpse into the criteria, there are numerous problems with them.  First, the non-binding nature of these criteria provides no guidance or comfort to individuals who are potentially subject to Park liability.  FDA goes to great lengths to state that the criteria “do not create or confer any rights or benefits for or on any person, and 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.”  So the criteria are not really criteria at all.

More significantly, there is nothing groundbreaking or enlightening contained in the criteria.  The seven listed criteria (see here under "Special Procedures and Considerations for Park Doctrine Prosecutions"), in addition to the individual’s position in the company and relationship to the violation, and whether the official had the authority to correct or prevent the violation, include:

(1) whether the violation involves actual or potential harm to the public;
(2) whether the violation is obvious;
(3) whether the violation reflects a pattern of illegal behavior and/or failure to heed prior warnings;
(4) whether the violation is widespread;
(5) whether the violation is serious;
(6) the quality of the legal and factual support for the proposed prosecution; and
(7) whether the proposed prosecution is a prudent use of agency resources.

These 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.  Indeed, FDA refuses to provide any examples of “either the categories of persons that may bear a responsible relationship to a violation or the types of conduct that may be viewed as causing or contributing to a violation.” 

Lastly, while it may make FDA feel powerful to articulate principles for prosecution, the true power and authority for proceeding criminally lies with the U.S. Attorneys’ Offices throughout the country and the Department of Justice.  The enforcement discretion ultimately lies with the prosecutors, despite whether the criteria laid out by FDA are satisfied. 

Thanks to our colleagues at Ropes & Gray for being persistent in their FOIA request for the publication of these criteria.  While it is generally helpful to see the factors for criminal prosecution under the Park doctrine published in FDA’s Regulatory Procedures Manual, the public has waited a long time for an obvious statement of factors that the Supreme Court, subsequent case law, and DOJ policy has already made clear.  

ADDITIONAL READING:

• HP&M's FDA and the Park Doctrine Slide Presentation
• FDLI Update article