News & Analysis as of

Prescription Drugs Department of Justice (DOJ)

Ballard Spahr LLP

Antitrust In Flux: What's Shaping the Life Sciences Industry

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Under the current administration, there have been significant shakeups at the antitrust enforcement agencies, including the FTC and the DOJ Antitrust Division, which have led to uncertainty regarding enforcement priorities....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

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

Troutman Pepper Locke

State AGs Join $202M Settlement Over HIV Drug Kickback

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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

Sheppard Mullin Richter & Hampton LLP

DOJ and FTC Host Second Session on Structural and Regulatory Impediments to Drug Competition

On July 24, 2025, the Federal Trade Commission (“FTC”) and the U.S. Department of Justice (“DOJ”) convened the second of three public listening sessions aimed at identifying barriers to drug price competition in the U.S....more

Troutman Pepper Locke

Second FTC and DOJ Listening Session Focuses on Formulary and Benefit Practices and Regulatory Abuse in the Pharmaceutical...

Troutman Pepper Locke on

On July 24, the Department of Justice (DOJ) and Federal Trade Commission (FTC) held the second of three listening sessions focused on competition in the pharmaceutical marketplace as part of the agency's implementation of the...more

ArentFox Schiff

Investigations Newsletter: Johnson & Johnson Challenges the Constitutionality of FCA $1.6 Billion Verdict

ArentFox Schiff on

Johnson & Johnson Challenges the Constitutionality of FCA $1.6 Billion Verdict - Following a record $1.6 billion jury verdict for off-label promotion of HIV drugs Prezista and Intelence, Johnson & Johnson (J&J) subsidiary...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

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

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

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

Morrison & Foerster LLP

Trump Antitrust Enforcers Take Aim at High Drug Costs, With Uncertain Path Forward

Just before Americans celebrated the Fourth of July, on June 30, 2025, antitrust enforcers from both the Federal Trade Commission (FTC) and Department of Justice Antitrust Division (DOJ) hosted the first of two listening...more

Goodwin

DOJ and FTC Host ‘Listening Sessions’ on Competition Issues in the Pharmaceutical Industry

Goodwin on

In two recent public panels, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) hosted the first of three joint listening sessions mandated by Executive Order No. 14273, Lowering Drug Prices by Once Again...more

ArentFox Schiff

Investigations Newsletter: Federal Court Imposes Nearly $1 Billion in FCA Damages and Penalties Against Omnicare and CVS

ArentFox Schiff on

Federal Court Imposes Nearly $1 Billion in FCA Damages and Penalties Against Omnicare and CVS - On July 7, Southern District of New York District Judge Colleen McMahon increased a False Claims Act (FCA) judgment from $136...more

Dorsey & Whitney LLP

DOJ & HHS Announce Reinvigoration of False Claims Act Working Group and Healthcare Fraud Enforcement Priorities

Dorsey & Whitney LLP on

The Department of Justice and the Department of Health and Human Services announced the reinvigoration of a False Claims Act (“FCA”) Working Group, a joint effort between the two agencies. ...more

Warner Norcross + Judd

Insights from the Largest DOJ Health Care Fraud Enforcement Effort in U.S. History

On June 30, the Department of Justice (DOJ) announced the largest coordinated health care fraud enforcement effort in U.S. history, involving criminal charges against over 300 defendants and over $14.6 billion in health care...more

Miles & Stockbridge P.C.

DOJ Remains Focused on Domestic Health Care Fraud

The Department of Justice (DOJ) recently issued its annual Health Care Fraud Takedown results, announcing a record-breaking 324 defendants, including 96 doctors and licensed professionals, as well as more than $14.6 billion...more

Polsinelli

DOJ Unveils Record-Breaking National Health Care Fraud Takedown

Polsinelli on

Key Takeaways - DOJ’s 2025 National Health Care Fraud Takedown was a record-breaking operation that resulted in criminal charges against 324 defendants and targeted schemes involving over $14.6 billion in intended losses....more

Troutman Pepper Locke

FTC Holds Its First Listening Session on Practices and Regulations Impacting Pharmaceutical Generic or Biosimilar Competition

Troutman Pepper Locke on

On June 30, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) held the first of three listening sessions focused on ways to lower Americans’ drug prices through competition. The panels are being held as...more

BakerHostetler

DOJ Announces Record-Breaking National Health Care Fraud Takedown Against 324 Defendants with Over $14.6 Billion in Alleged Fraud

BakerHostetler on

The DOJ announced on June 30 an unprecedented Health Care Fraud Takedown resulting in criminal charges against 324 defendants (including 96 doctors, nurse practitioners, pharmacists and other licensed providers), with an...more

Husch Blackwell LLP

False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement

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Host Jonathan Porter welcomes back to the show Husch Blackwell attorney Abe Souza to discuss False Claims Act (FCA) enforcement in the pharmacy context. Pharmacies face multiple pressures, from disruptive online enterprises...more

Mintz - Health Care Viewpoints

DOJ Civil Division Publishes Memo Outlining Trump Administration Civil Enforcement Priority Related to Health Care

In May 2025 the Department of Justice (DOJ) Criminal Division published its enforcement priorities, and the Civil Division has now followed suit with a memorandum of its own (the “Civil Division Memo”)...more

Katten Muchin Rosenman LLP

FTC and DOJ Announce Listening Sessions on Lowering American’s Drug Prices

On April 15, 2025, President Donald Trump issued  Executive Order No. 14273, “Lowering Drug Prices by Once Again Putting Americans First, ” which outlines a series of targeted actions to lower prescription drug costs and...more

Robinson+Cole Health Law Diagnosis

False Claims Act Enforcement of Pharmacy Pricing & Prescribing Practices: The Walgreens Cases

The Department of Justice has launched a number of enforcement actions targeting pharmacies for alleged violations of the False Claims Act (FCA). Recently, Walgreens has been the subject of two noteworthy government...more

Arnall Golden Gregory LLP

What the Dissolution of DOJ’s Consumer Protection Branch Means for Future Life Sciences and Consumer Protection Enforcement

The Department of Justice’s decision to shutter the Consumer Protection Branch (“CPB”) by September 30, 2025, is sending shockwaves across multiple industries. Known for its unique dual mandate to pursue both civil and...more

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