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Enforcement Actions Manufacturers Pharmacies

Tucker Arensberg, P.C.

DOJ and HHS Launch New False Claims Act Working Group to Target Healthcare Fraud

Tucker Arensberg, P.C. on

The U.S. Department of Health and Human Services (HHS) and the Department of Justice (DOJ) have jointly announced the launch of a reinvigorated DOJ-HHS False Claims Act Working Group aimed at enhancing interagency...more

Harris Beach Murtha PLLC

GLP-1 Weight-Loss Drugs Off Shortage List; Deadlines to Stop Compounding

Glucagon-like peptide-1 agonists, a class of medications known as GLP-1s, have grown in popularity, initially for the treatment of type 2 diabetes and more recently for obesity and other labeled and off-label indications for...more

Hogan Lovells

Prescription Medical Device Manufacturers, Distributors, and the NABP: The Role in State Licensing

Hogan Lovells on

The National Association of Boards of Pharmacy (NABP) plays an important role in the state licensing of prescription medical device manufacturers and distributors. Although the NABP does not directly regulate the...more

Gardner Law

FDA Issues Numerous Warning Letters

Gardner Law on

The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | August 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for August 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more

Bass, Berry & Sims PLC

Third Circuit Ruling Allows Restrictions on 340B Contract Pharmacies

On January 30, the U.S. Court of Appeals for the Third Circuit issued a unanimous decision in favor of drug manufacturers, finding that manufacturer restrictions on the use of contract pharmacies under the 340B drug pricing...more

Sheppard Mullin Richter & Hampton LLP

Contract Pharmacies and the 340B Drug Discount Program: New Litigation and an Advisory Opinion Point to Ongoing Skirmishes on the...

On December 11, 2020, five hospital groups, including the American Hospital Association (“AHA”), and an organization of hospital pharmacists representing participants in the 340B drug pricing program (“340B Program”), filed a...more

Foley Hoag LLP - Medicaid and the Law

The 340B Contract Pharmacy Saga Continues

Donald Trump extended two directives restricting the admission of certain immigrants and nonimmigrants to the U.S. Specifically, Presidential Proclamation (PP) 10014 restricting the admission of first-time immigrants and PP...more

ArentFox Schiff

Deputy Associate Attorney General Sheds Light on DOJ’s FCA Priorities at Annual False Claims Act Conference

ArentFox Schiff on

“Enforcing the False Claims Act is a top priority for the Department—not just for our office,” said Deputy Associate Attorney General Stephen Cox, the Keynote Speaker for the 2020 Advanced Forum on False Claims and Qui Tam...more

Sheppard Mullin Richter & Hampton LLP

HHS Proposes Rule to Eliminate Safe Harbor for PBM Drug Rebates

On February 6, 2019, the Office of the Inspector General of the U.S. Department of Health and Human Services (the “OIG”) published in the Federal Register a proposed rule (the “Proposed Rule”) that, if made final in its...more

Holland & Knight LLP

FDA Commissioner Speaks Out on Compliance and Enforcement

Holland & Knight LLP on

On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more

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