Regulatory: FDA Is Equipping The Park Doctrine

The FDA has become increasingly active in its determination to discipline apparently unrepentant pharmaceutical firms.  Now its getting personal, again.  After years of neglect the usefulness of the Park Doctrine has been rediscovered by the FDA.  The evidence needed to apply it to a “responsible corporate official” appears to be nil.  The definition of a “responsible corporate official” is nearly as vague.  It would seem to be a good time for anyone attempting to skirt FDA regulations to tread lightly.   Although the initial violation of the Federal Food, Drug, and Cosmetic Act is considered a misdemeanor a second violation is a felony.  It should be noted that transgressions in the Food and Cosmetics areas are also included by default if not intent.

From 6-5-3 – Special Procedures and Considerations for Park Doctrine

Recommending Park Doctrine Prosecutions

The Park Doctrine, as established by Supreme Court case law, provides that a responsible corporate official can be held liable for a first time misdemeanor (and possible subsequent felony) under the Federal Food, Drug, and Cosmetic Act (“the Act”) without proof that the corporate official acted with intent or even negligence, and even if such corporate official did not have any actual knowledge of, or participation in, the specific offense. A Park Doctrine prosecution, for the purposes of this section, refers to a recommended prosecution of a responsible corporate official for a misdemeanor violation of the Act.

Misdemeanor prosecution under the Act can be a valuable enforcement tool. Such prosecutions are referred to the Department of Justice. Once a person has been convicted of a misdemeanor under the Act, any subsequent violation of the Act is a felony, even without proof that the defendant acted with the intent to defraud or mislead. Misdemeanor prosecutions, particularly those against responsible corporate officials, can have a strong deterrent effect on the defendants and other regulated entities. In some cases, a misdemeanor conviction of an individual may serve as the basis for debarment by FDA.

When considering whether to recommend a misdemeanor prosecution against a corporate official, consider 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. Knowledge of and actual participation in the violation are not a prerequisite to a misdemeanor prosecution but are factors that may be relevant when deciding whether to recommend charging a misdemeanor violation.

Other factors to consider include but are not limited to:

  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.

As the Supreme Court has recognized, it would be futile to attempt to define or indicate by way of illustration 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 of the Act. In addition, these factors are intended solely for the guidance of FDA personnel, 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 evident.”

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