Vaccine Enforcement and Litigation

A last consideration of vaccine development is possible exposure to enforcement actions, which can include warning letters, recalls, civil penalties, or criminal prosecutions. The Public Readiness and Emergency Preparedness (PREP) Act provides targeted liability immunity to covered entities for measures taken in relation to certain countermeasures during a public health emergency. This session will discuss the above enforcement and litigation concepts and provide examples related to COVID-19.

  1. Prohibited Acts Under the Federal Food, Drug, and Cosmetic Act
  2. FDA and U.S. Department of Justice Enforcement Tools and Procedures
  3. Liability Protection and Vaccine Injury Compensation under the PREP Act

Gregory H. Levine, Partner, Ropes & Gray LLP
Beth P. Weinman, Partner, Ropes & Gray LLP

This session was recorded as part of FDLI’s Virtual Fundamentals of Vaccine Regulation Course in February 2021. 



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