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.
- Prohibited Acts Under the Federal Food, Drug, and Cosmetic Act
- FDA and U.S. Department of Justice Enforcement Tools and Procedures
- 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.
GREGORY LEVINE is chair of the FDA Regulatory practice group at Ropes & Gray LLP. He focuses his practice on FDA regulation of pharmaceuticals, biotechnology and medical devices, regularly representing such clients before state and federal regulators on all phases of the product lifecycle, and assisting with both internal and government compliance investigations and enforcement actions. Greg also advises manufacturers of other FDA-regulated products, including cosmetics and dietary supplements, on a broad range of issues under the Food, Drug, and Cosmetic Act and related laws. Prior to joining Ropes & Gray, Greg was a partner at an international law firm in Washington, DC. He is also a former legislative staff member in the US House of Representatives, where he worked on FDA-related legislation, policy, and appropriations.
BETH P. WEINMAN is a member of Ropes & Gray’s life sciences regulatory and compliance practice group, and focuses her practice on FDA regulation and enforcement of laws governing pharmaceuticals, biologics, medical devices and foods, including dietary supplements. Beth represents clients in False Claims Act (FCA) and Federal Food, Drug, and Cosmetic Act (FDCA) investigations, and other enforcement actions before state and federal regulators, and also represents clients in administrative litigation matters. Beth also provides counseling on issues related to marketing practices, current good manufacturing practices, good clinical practices, compounding, medical product development and approval, and product recalls and withdrawals. Prior to joining Ropes & Gray, Beth spent nearly eight years as Associate Chief Counsel for Enforcement within FDA’s Office of Chief Counsel. In that role, she worked closely with FDA’s Office of Criminal Investigations, the Department of Justice and other government agencies to investigate and, when appropriate, prosecute alleged violations of the FDCA and related crimes under Title 18 (including, e.g., mail fraud, wire fraud, healthcare fraud, and conspiracies to defraud). She also worked on numerous parallel and independent FCA investigations involving FDA regulated drugs and devices, including biologics. Before starting at FDA,Beth spent more than seven years as an associate in the litigation department of a large New York law firm, where, among other matters, she represented a number of pharmaceutical companies in government investigations and securities class action lawsuits.Get Access
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