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In Law360, Attorneys Analyze Two HHS Opinions That Support Broad Immunity from COVID-19 Liability

Practices: Health Care, FDA Regulatory, Clinical Research

The U.S. Department of Health and Human Services’ Office of General Counsel recently issued two advisory opinions interpreting the scope and application of liability immunity under the Public Readiness and Emergency Preparedness (PREP) Act. 

A Law360 article analyzing these HHS opinions explains that one, in particular, demonstrates the broad potential application of PREP Act immunity to entities that may not directly manufacture, administer, or use Covered Countermeasures but that are nevertheless involved in the response to the COVID-19 pandemic as program planners and follow the guidance of public health authorities. HHS’s guidance regarding the broad application of the term program planner is useful to entities like universities and employers that have sponsored large COVID-19 testing programs during the pandemic but are themselves neither manufacturers nor distributors of such tests. 

The article was authored by life sciences regulatory & compliance partner and chair Greg Levine (Washington, D.C.), health care partner David Peloquin (Boston) and life sciences regulatory and compliance associate Joshua Oyster (Washington, D.C.).

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