News & Analysis as of

Enforcement Actions Prescription Drugs

Cozen O'Connor

TX AG Prescribes Legal Action Against Eli Lilly for Alleged Kickbacks

Cozen O'Connor on

Texas AG Ken Paxton has sued pharmaceutical manufacturer Eli Lilly for allegedly bribing and illegally inducing medical providers to prescribe and continue prescribing several Lilly drugs—including GLP-1 medications Mounjaro...more

Foley & Lardner LLP

Health Care Marketing Enforcement: FTC Targets Telehealth Company for Deceptive Weight Loss Marketing Claims

Foley & Lardner LLP on

On July 14, 2025, the operators of telemedicine company Southern Health Solutions, Inc., doing business as Next Medical and NextMed, agreed to settle the Federal Trade Commission’s (FTC) charges that the company’s weight‑loss...more

Blank Rome LLP

Federal and State Agencies Ramp Up Scrutiny of the GLP-1 Drug Market

Blank Rome LLP on

Overview - As demand for GLP-1 drugs continues to skyrocket, federal and state agencies are turning their attention to the GLP-1 market and ramping up efforts to address the perceived risks associated with counterfeit and...more

Cozen O'Connor

The State AG Report – 08.07.2025

Cozen O'Connor on

Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: • Weighty Penalty for Bootleg GLP-1 Drug Sales - • 50 AGs...more

Carlton Fields

Agency Actions, Trade Deals, and Other Initiatives to Further Executive Order Goals for the Pharma Industry

Carlton Fields on

The Trump administration has issued numerous pharma-focused executive orders, including “Lowering Drug Prices by Once Again Putting Americans First,” “Regulatory Relief to Promote Domestic Production of Critical Medicines,”...more

Husch Blackwell LLP

DOJ Announces Largest-Ever National Healthcare Fraud Takedown and Launches New Data Fusion Center

Husch Blackwell LLP on

In June 2025, the Department of Justice (DOJ) announced its 2025 National Health Care Fraud Takedown, marking the largest coordinated healthcare fraud enforcement action in DOJ history. The sweep included charges against a...more

Cozen O'Connor

Weighty Penalty for Bootleg GLP-1 Drug Sales

Cozen O'Connor on

Connecticut AG William Tong announced a settlement with Triggered Brand following allegations that the company unlawfully advertised and sold counterfeit GLP-1 weight loss drugs in violation of state consumer protection laws....more

Foley & Lardner LLP

GLP-1 Drugs: Ohio Board of Pharmacy Issues FAQs for Compounders

Foley & Lardner LLP on

Share on Twitter Print Share by Email Share Back to top In spring 2025, the Food and Drug Administration (FDA) resolved and ended the GLP-1 medications shortage, subsequently releasing declaratory orders that neither...more

Troutman Pepper Locke

State AGs Join $202M Settlement Over HIV Drug Kickback

Troutman Pepper Locke on

On July 16, 49 attorneys general (AGs) announced that they joined a $202 million settlement with Gilead Sciences, Inc. (Gilead). Previously announced by the Department of Justice in April, the settlement resolved allegations...more

Ropes & Gray LLP

[Podcast] Patient Assistance Programs: Enforcement Trends and Regulatory Challenges

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On this Ropes & Gray podcast, health care partner Michael Lampert and counsel Sam Perrone, and litigation & enforcement partner Andrew O’Connor, rejoin to discuss patient assistance programs, recent enforcement actions, and...more

Vedder Price

DOJ Charges 324 Defendants in Unprecedented Health Care Fraud Takedown

Vedder Price on

On June 30, 2025, the Department of Justice (DOJ) filed criminal charges against 324 defendants across the country alleging participation in various health care fraud schemes. The DOJ identified the operation as the 2025...more

A&O Shearman

European Commission fines Alchem in first cartel case involving a pharmaceutical API

A&O Shearman on

On 4 July 2025, the EC fined Alchem and its subsidiary EUR 489,000 for their role in a long-running cartel concerning the active pharmaceutical ingredient SNBB, used in the production of Buscopan and its generics. This marks...more

WilmerHale

2024 CMS Audit and Enforcement Report

WilmerHale on

On July 15, 2025, the Centers for Medicare & Medicaid Services (CMS) released an Audit and Enforcement Report summarizing its annual Medicare Advantage (Part C) and Prescription Drug (Part D) program audits and enforcement...more

Hogan Lovells

Investigation highlights risks of collaboration between pharmaceutical manufacturers and telehealth providers

Hogan Lovells on

Four U.S. senators reported their findings of a nine-month investigation into direct-to-consumer telehealth platforms used by pharmaceutical manufacturers, highlighting risks and reinforcing the need for industry to carefully...more

Cozen O'Connor

The State AG Report – 07.17.2025

Cozen O'Connor on

Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •Democratic AGs Oppose Washing Away Appliance Efficiency...more

Shumaker, Loop & Kendrick, LLP

Client Alert: Have You Looked at Who is Coming to Dinner and How It Impacts Your Compliance?

Several States' Attorneys General reported resolving a case alleging that Gilead Sciences ran an illegal kickback scheme to promote the use of its HIV medications. The government alleged that Gilead utilized various methods,...more

Cozen O'Connor

AGs Inject Accountability into Pharma Practices via $202M Gilead Settlement

Cozen O'Connor on

New York AG Letitia James, along with a bipartisan coalition of 48 other AGs and in coordination with the U.S. DOJ, announced a $202 million settlement in principle with Gilead Sciences, Inc. (“Gilead”), to resolve...more

Cozen O'Connor

Bipartisan Coalition of AGs Secures $720 Million Settlement with Opioid Manufacturers

Cozen O'Connor on

Virginia AG Jason Miyares, along with a bipartisan coalition of eight other AGs, announced a $720 million settlement with eight opioid drug manufacturers to resolve allegations that they contributed to the opioid epidemic....more

Cozen O'Connor

FDA Transparency Push: CRLs Released

Cozen O'Connor on

On July 10, 2025, citing a drive to increase transparency, the Food and Drug Administration (“FDA”) published more than 200 complete response letters (CRLs) previously issued to companies that had submitted new drug...more

Proskauer - Health Care Law Brief

DOJ Targets Gender‑Affirming Care under FDCA and FCA: Scrutinizes Off‑Label Drug Use and False Diagnosis Codes

Last month, the United States Department of Justice (“DOJ”) issued its “Civil Division Enforcement Priorities” memorandum, memorializing a shift from its predecessor administration’s policy on gender‑affirming healthcare...more

Holland & Knight LLP

Recent FDA Actions Pose Big Changes and Questions for Health and Food Industries

Holland & Knight LLP on

Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and proposed regulatory changes that could dramatically impact the drug, biologics and...more

Epstein Becker & Green

The First National Health Care Fraud Takedown of the Second Trump Administration: What Stayed the Same and What is New?

Epstein Becker & Green on

On June 30, 2025, the U.S. Department of Justice (“DOJ”), together with the U.S. Department of Health and Human Services Office of Inspector General (“HHS OIG”) and other law enforcement partners, announced the results of the...more

Polsinelli

Device Patents in the Orange Book: May 21, 2025, FTC Warning Letters Appear to have Minimal Impact

Polsinelli on

Key Takeaways The Federal Trade Commission (FTC) has continued its scrutiny of Orange Book listings for device patents, signaling bipartisan concern over potential anti-competitive practices....more

King & Spalding

District Court Orders CVS Caremark to Pay U.S. Government $95 Million

King & Spalding on

On June 25, 2025, Chief Judge Mitchell S. Goldberg of the U.S. District Court for the Eastern District of Pennsylvania issued a ruling in the case of U.S. ex rel. Sarah Behnke v. CVS Caremark Corp. et al., ordering CVS...more

Mintz - Health Care Viewpoints

FDA in Flux — July 2025 Newsletter

Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies....more

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