News & Analysis as of

Public Readiness and Emergency Preparedness Act (PREP Act) Secretary of HHS

Sheppard Mullin Richter & Hampton LLP

Authorized Government Contractors Now Covered Persons Under the PREP Act

The Secretary of the U.S. Department of Health and Human Services recently added government contractors to the list of entities eligible for immunity from liability under the Secretary’s March 17, 2020, Public Readiness and...more

ArentFox Schiff

COVID-19 Tests No Longer Need Authorization by FDA for Marketing

ArentFox Schiff on

In the Food and Drug area, we don’t often get dramatic changes in FDA policies, but an announcement from the Secretary of HHS, published on August 18, appears to be just such a dramatic change. In the new announcement, HHS...more

Troutman Pepper

Federal Court Ruling Casts Doubt on Nursing Homes’ Ability to Use PREP Act to Remove State-Law Claims

Troutman Pepper on

Why It Matters - This decision casts doubt on the ability of nursing homes to rely on the PREP Act to shield them from liability against state-law claims or, at the very least, to remove such claims to federal court....more

Faegre Drinker Biddle & Reath LLP

FDA’s Revocation of the Hydroxychloroquine and Chloroquine EUA May Test the Limits of PREP Act Immunity

On June 15, 2020, the U.S. Food & Drug Administration (FDA) revoked the Emergency Use Authorization (EUA) that permitted emergency distribution of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) from the...more

Conn Kavanaugh

Products Intended to Fight COVID-19 Protected by Broad – but Not Unlimited – Immunity From Suit

Conn Kavanaugh on

On January 31, 2020, the Secretary of the United States Department of Health and Human Services declared a public health emergency under the Public Health Service Act to aid the health care community’s response to the spread...more

Seyfarth Shaw LLP

HHS Advisory Opinion Concludes that the PREP Act Preempts Any State or Local Law that Prohibits Pharmacists from Administering...

Seyfarth Shaw LLP on

On May 19, 2020, the US Department of Health and Human Services (HHS) Office of General Counsel (OGC) issued an advisory opinion (Advisory Opinion) finding that the Public Readiness and Emergency Preparedness Act1(PREP Act)...more

Baker Donelson

Long Term Care Liability During the COVID-19 Pandemic: Ways State Governments Can Ensure Protection

Baker Donelson on

Long term care facilities and providers are bearing the brunt of caring for the nation's largest and most vulnerable populations of COVID-19 patients. And they're doing so in the face of considerable uncertainty, insufficient...more

Seyfarth Shaw LLP

Health CARES - Regulatory Waivers for Long Term Care Facilities

Seyfarth Shaw LLP on

As previously reported, the CARES Act impacts long-term care (LTC) facilities, including skilled nursing facilities (SNFs) and nursing facilities (NFs). In addition to this legislative action, the Centers for Medicare and...more

ArentFox Schiff

Expanded Products Liability Immunity in the COVID-19 Crisis

ArentFox Schiff on

On March 17, 2020, Secretary Alex Azar of the Department of Health and Human Services (HHS) issued a Declaration, see 85 Fed. Reg. 15198, invoking the products liability immunity protections within the Public Readiness and...more

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