An Evolving Approach to Enforcement in the Life Sciences Sector

Avia M. Dunn Alexandra M. Gorman

On June 15, litigation counsel Avia Dunn and life sciences and health care counsel Alexandra Gorman presented a Lawline webinar titled “An Evolving Approach to Enforcement in the Life Sciences Sector.” The program explored recent enforcement trends against pharmaceutical and medical device manufacturers by the government’s primary enforcers: Department of Justice, Food and Drug Administration, and Office of Inspector General for the United States Department of Health and Human Services. Ms. Dunn and Ms. Gorman analyzed the types of civil and criminal cases the government chose to prosecute, examined trends in FDA enforcement, including the DOJ’s enforcement strategy regarding off-label, and explored the evolution of the OIG’s use of corporate integrity agreements.

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