Drugs

Ways to Mitigate Park Doctrine Risks: Attorney

David McFarland

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Attorney Amanda Johnston (Gardner Law) says there are five steps leaders of FDA-regulated companies can take to mitigate the risk of Park Doctrine (Responsible Corporate Officer Doctrine) violations. Writing in an online blog post, Johnston says the doctrine “imposes strict, vicarious criminal liability upon responsible corporate officers for misdemeanor Federal Food, Drug, and Cosmetic Act violations” even without proof of negligence, intent, involvement, or even knowledge. The liability is based solely on the corporate officer’s duties, role, and responsibilities, she says.

Johnston’s best practices and recommendations are:

  • a compliant and operational quality management system is essential;
  • a robust and effective healthcare compliance program is essential;
  • make good hiring and promotion decisions;
  • establish clear expectations regarding responsibilities; and
  • be proactive in identifying and addressing issues (e.g., quality deficiencies, problematic marketing programs).

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