PREP Act

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Earlier this month, in response to the end of the COVID-19 public health emergency, the Department of Health and Human Services (“HHS”) issued the Eleventh Amendment to the declaration under the Public Readiness and Emergency Preparedness Act (“PREP Act”) for medical countermeasures against COVID-19. The PREP Act allows the Secretary of HHS to provide liability immunity, through a declaration, to certain individuals and entities against claims associated with the manufacture, distribution, administration, or use of certain defined medical products or devices, referred to as countermeasures.

HHS originally announced this PREP Act declaration in January 2020 in response to the COVID-19 pandemic (the “Declaration”).  The Declaration has been amended at various points throughout the pandemic.  This latest amendment makes several different updates:Continue Reading HHS Amends and Extends COVID-19 PREP Act Declaration

The Biden Administration plans to put an end to the COVID-19 health emergencies on May 11, 2023, according to a Statement of Administration Policy submitted to the Rules Committee of the House of Representatives today.

The statement was presented in opposition to two items that the committee was considering for submission to the full House: The Pandemic is Over Act (H.R. 382) and a resolution relating to a national emergency declared by the President (H.J. Res. 7).

The administration’s policy statement indicated that the plan is to end both the public health emergency (PHE) declaration that was issued by the Secretary of Health and Human Services in January 2020 and the related national emergency issued by President Trump in March 2020.Continue Reading Administration may end public health emergencies in May 2023

On the last full day of the Trump Administration, the Department of Justice (DOJ) submitted a statement of interest in litigation supporting the position that the Public Readiness and Emergency Preparedness (PREP) Act preempts legal claims relating to the administration or use of covered countermeasures with respect to a public health emergency and, therefore, makes…