FDA update – March 21, 2011

FDA Releases Park Doctrine Guidance 

As most in FDA-regulated industry have been hearing, there has been a chorus of calls for increased individual accountability. FDA Commissioner Margaret Hamburg publicly called for
increased prosecution of “responsible corporate officers” under the FDCA. The responsible corporate officer (RCO) doctrine, or so-called Park Doctrine, allows senior-level individuals in FDA-regulated companies to be charged for violating the FDCA, even where the individual neither knew of nor participated in the underlying misconduct. 

Individuals convicted under the Park Doctrine are subject to criminal fines, debarment by FDA and, in some cases, exclusion from participation in federal health care programs.

FDA has issued special procedures and considerations for Park prosecution recommendations. Notable among the FDA’s stated Considerations is a paradoxical policy statement: “Misdemeanor prosecutions, particularly those against responsible corporate officials, can have a strong deterrent effect on the defendants and other regulated entities.” 

A trademark of Park liability is that RCOs can be held liable without proof of intent, without proof of negligence or without proof of knowledge. It seems difficult to imagine that prosecutions of individuals who have no intent or knowledge of an underlying FDCA violation could inhibit culpable conduct by other similarly situated individuals.

FDA instructs agency personnel to consider three primary factors when determining whether to recommend a Park prosecution: 
     (i) An individual’s position in a company
     (ii) An individual’s relationship to the violation 
     (iii) Whether the official had the authority to correct or prevent the violation.

The guidelines repeat that knowledge of and actual participation in a violation are not prerequisite factors to a Park prosecution, but are merely two relevant factors in considering whether to recommend an enforcement action. 

The guidelines identify additional factors for consideration, including: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;
  • Whether the violation is serious;
  • The quality of the legal and factual support for the proposed prosecution; and Whether the proposed prosecution is a prudent use of agency resources.

    If there are any questions on this new Pilot program please contact us via email at info@mdiconsultants.com and Ref: Park Doctrine.