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Trump Administration False Claims Act (FCA) Pharmaceutical Industry

A&O Shearman

Pharma Company Brings Latest Constitutional Challenge To False Claims Act In Third Circuit

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On April 29, 2025, a pharmaceutical company filed the latest constitutional challenge to the qui tam provision of the False Claims Act (“FCA”) when it appealed in the United States Court of Appeals for the Third Circuit a...more

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - July 2025

Latham & Watkins LLP on

On July 4, 2025, President Trump signed into law the One Big Beautiful Bill Act, his signature policy legislation. Two aspects of this legislation are particularly relevant for drug pricing....more

Cozen O'Connor

Whistleblower Watch - A quarterly update on FCA Enforcement and Qui Tam Litigation - June 2025

Cozen O'Connor on

Whistleblower Watch is a comprehensive source for all False Claims Act (FCA) news and information. Every quarter, Cozen O’Connor will provide in-house counsel and compliance professionals with a summary of the most notable...more

Ropes & Gray LLP

DOJ Is Not Taking Its Foot Off the Gas in Health Care Fraud Enforcement: What DOJ’s New White-Collar Enforcement Plan Means for...

Ropes & Gray LLP on

On May 12, 2025, the Head of the US Department of Justice’s Criminal Division, Matthew R. Galeotti (“Galeotti”), announced DOJ’s first ever White-Collar Enforcement Plan (the “Plan”), which directs prosecutors to: (1) focus...more

DLA Piper

DOJ Memo Identifies False Claims Act and Enforcement Risks Related to Gender Transition Medication and Procedures

DLA Piper on

Attorney General (AG) Pam Bondi has issued a memorandum titled “Preventing the Mutilation of American Children” (the Memo) to select Component Heads of the Department of Justice (DOJ). Released on April 22, 2025, the Memo...more

Skadden, Arps, Slate, Meagher & Flom LLP

Speaker Program Settlement Highlights Compliance Risks for Life Sciences Companies

On April 29, 2025, the U.S. Attorney’s Office for the Southern District of New York (SDNY) announced a $202 million civil False Claims Act (FCA) settlement with Gilead based on allegations that the company’s speaker program...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | January 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2025. This month features long-awaited proposed and final rules regarding the Health Insurance Portability and Accountability...more

Lowenstein Sandler LLP

In Trump’s Second Term, Healthcare Enforcement May Remain Business as Usual

Compared with other issues, healthcare enforcement during President-elect Donald Trump’s upcoming second term has received little attention. When he takes office again on January 20, should industry actors like pharmaceutical...more

White & Case LLP

Trump Administration’s Eleventh-Hour Drug Pricing Regulations Face an Uncertain Path Forward

White & Case LLP on

The Trump Administration recently announced two final rules that implement policy objectives to lower drug prices by tying certain Medicare Part B payments to prices paid by other countries and by replacing an anti-kickback...more

WilmerHale

Decoupling From China: Part 3 - Oversight And The Election

WilmerHale on

The COVID-19 pandemic and the serious supply chain vulnerabilities it exposed have led to a seismic shift in U.S. policy and regulation, from stepped-up measures to protect U.S. technology, intellectual property and data from...more

Skadden, Arps, Slate, Meagher & Flom LLP

Drug Pricing Concerns Drive Continued DOJ Focus on Life Sciences Companies

In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more

Troutman Pepper Locke

HHS Proposes 'Sweeping' Changes to Pharmacy Drug Pricing

Troutman Pepper Locke on

The pharmacy benefit manager (PBM) industry recently has come under significant scrutiny by the Trump administration....more

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