News & Analysis as of

Healthcare Rulemaking Process Enforcement Actions

Skadden, Arps, Slate, Meagher & Flom LLP

Closing the GRAS Loophole: Secretary Kennedy’s Plan To Enhance FDA Food Safety Regulations

On March 10, 2025, Health Secretary Robert F. Kennedy Jr. initiated a significant shift in the regulation of ultra-processed foods by directing the Food and Drug Administration (FDA) to revise the GRAS (Generally Recognized...more

Brownstein Hyatt Farber Schreck

Breaking Down a New Day at the CFPB

After weeks of emptying the shelves at the Consumer Financial Protection Bureau (CFPB) with dozens of enforcement actions, new rules, proposed regulations and guidance, President Donald Trump fired CFPB Director Rohit Chopra...more

McDermott Will & Emery

What Makes a Patient a “Patient”? Court Rejects Restrictive 340B Definition

McDermott Will & Emery on

On November 3, 2023, the US District Court for the District of South Carolina issued a landmark order in Genesis Health Care, Inc. v. Becerra, a case analyzing the definition of a “patient” under the 340B Program Statute. The...more

Ankura

The Department of Justice’s Withdrawal of Three Antitrust Statements and the Impact on Health Care Organizations

Ankura on

On February 3, 2023, the Department of Justice Antitrust Division (DOJ) announced the withdrawal of three policy statements that have long guided the information exchanges as well as the related enforcement in the healthcare...more

Arnall Golden Gregory LLP

Long-Term Care Facilities Brace for Additional OSHA Inspections Under Extended COVID-19 NEP

The Occupational Safety and Health Administration (“OSHA”) announced on June 30, 2022, that it was extending “until further notice” its revised COVID-19 National Emphasis Program (“NEP”), which had been set to expire on July...more

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