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Enforcement Actions Federal Trade Commission (FTC) Pharmaceutical Industry

Blank Rome LLP

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

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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

Haug Partners LLP

FTC Issues a Third Round of Warning Letters Over Improper Orange Book Listings

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On May 21, 2025, the Federal Trade Commission (FTC) renewed its efforts to challenge pharmaceutical manufacturers that have allegedly listed patents improperly in the Food and Drug Administration’s (FDA) publication of...more

McDermott Will & Schulte

FTC Revives Orange Book Listing Challenges

On May 21, 2025, the Federal Trade Commission (FTC) issued its third round of warning letters – and its first under the Trump administration – against pharmaceutical manufacturers for allegedly improper listing of patents in...more

Axinn, Veltrop & Harkrider LLP

FTC Peeling Back the Layers of the Orange Book

The Federal Trade Commission (FTC) is continuing to pursue pharmaceutical manufacturers for allegedly improperly listing patents in the “Orange Book,” delaying the entry of generic drug competitors. On May 21, the FTC...more

McDonnell Boehnen Hulbert & Berghoff LLP

Federal Trade Commission Continues Efforts to Delist Drug Device Administration Patents in Orange Book

In the last years of the Biden Administration, the Federal Trade Commission issued a policy statement and sent letters to ten companies having Orange Book-listed patents claiming devices for administering drugs challenging...more

Polsinelli

Orange Book Listings: Republican Led FTC Picks Up Where Democrat Led FTC Left Off

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

Axinn, Veltrop & Harkrider LLP

Axinn Associates at the Antitrust Spring Meeting: Pharma Under the Antitrust Microscope

The Spring Meeting is the largest gathering of competition, consumer protection, and data privacy profes­sionals globally, with lawyers, academics, economists, enforcers, journalists, and students from around the world....more

Kelley Drye & Warren LLP

Mark Meador Confirmed as Newest Republican FTC Commissioner

...the Senate confirmed Mark Meador as the newest Republican commissioner of the Federal Trade Commission with a 50-46 vote along party lines. Meador’s confirmation solidifies a Republican majority on the Commission,...more

Morrison & Foerster LLP

Sights and Sounds from the Antitrust Section’s 2025 Spring Meeting

Antitrust experts from across the globe convened in Washington, D.C. on April 2–4, 2025 to discuss new enforcement policies and share updates on current issues in antitrust. We provide the key highlights from numerous panels...more

Cozen O'Connor

The State AG Report – 02.27.2025

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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: •Congress Urged to Send Message to Organized Retail Crime -...more

Polsinelli

Monday Morning (Advertising) Quarterback – Unprecedented Hims & Hers Super Bowl Ad Has Legislators Concerned

Polsinelli on

The Super Bowl is not just the biggest game of the year for football fans, but it is also one of advertising’s biggest nights. Therefore, the FDA lawyers at Polsinelli were not only tuned in to root for the Kansas City Chiefs...more

Hogan Lovells

State antitrust enforcers step into the spotlight

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Federal antitrust enforcement is entering a period of uncertainty in the second Trump administration. It is an open question what priorities Andrew Ferguson, the newly-appointed Federal Trade Commission (FTC) Chair, and Gail...more

Sheppard Mullin Richter & Hampton LLP

2025 Top-of-Mind Issues for Life Sciences Companies

DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more

Axinn, Veltrop & Harkrider LLP

The Fate of the “Last Gasp” of the Biden FTC: Will Its Legacy Survive the Trump Administration?

In the days leading up to President Trump’s inauguration, the Biden FTC rushed to initiate major lawsuits and to tie a bow on various antitrust policy efforts. In a series of dissenting statements, the minority Republican...more

Sheppard Mullin Richter & Hampton LLP

Looking Back and Looking Forward: Healthcare Antitrust in a New Administration: What Stays the Same and What Changes?

President Trump was sworn into office on Monday, promising swift action on several fronts. There is already a new Federal Trade Commission (“FTC”) Chair, Andrew Ferguson, with former FTC Chair Lina Khan expected to step down...more

McCarter & English, LLP

FTC Issues PBM Report Signaling Consolidation Is Impacting Pharmaceutical Prices

At a public meeting held on January 15, 2025, the Federal Trade Commission (FTC) summarized the Second Interim Staff Report (Second Report) stemming from its investigation into pharmacy benefit managers (PBMs) and their...more

Mintz - Health Care Viewpoints

EnforceMintz — Don’t Forget Your Other Regulators: Consumer Protection Enforcement in Health Care Markets

When considering the health care enforcement landscape in 2024 and where it might be headed in 2025, we would be remiss if we did not address the enforcement activities of state and federal agencies beyond those typically...more

Goodwin

FTC Escalates Battle Against PBMs With Complaint on Insulin Pricing

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FTC’s challenge is the culmination of years of investigation, but choice of venue and theories of harm reveal potential weaknesses....more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - May 9th - 10th, San Juan, Puerto Rico

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education on a wide variety of current and emerging topics...more

Knobbe Martens

Antitrust Lawsuit Brought Against Drug Manufacturer Based on Its Allegedly Improper Listing of Device Patents in the FDA’s Orange...

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As we recently discussed, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug Administration’s (“FDA”)...more

American Conference Institute (ACI)

[Event] 15th Annual Advanced Forum on Managed Care Disputes and Litigation - May 2nd - 3rd, Chicago, IL

ACI’s Advanced Forum on Managed Care Disputes and Litigation offers an unparalleled learning experience, specifically designed for the MCO legal community. Attend and develop winning legal strategies and business best...more

Goodwin

Antitrust & Competition Life Sciences Year in Review 2023

Goodwin on

Despite increasingly aggressive rhetoric from the agencies, 2022 was largely characterized as “business as usual” in the antitrust world. In contrast, 2023 featured a significant step up in enforcement activity, including...more

McDermott Will & Schulte

Antitrust M&A Snapshot - Q4 2023

IN THIS FEBRUARY 2024 ISSUE - UNITED STATES - New Merger Guidelines Released - The US Federal Trade Commission (FTC) and US Department of Justice Antitrust Division (DOJ) issued their updated Merger Guidelines on...more

Troutman Pepper Locke

FTC and Bipartisan State AGs Win Landmark Case Against ‘Pharma Bro’ Martin Shkreli Over Daraprim Monopoly

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On January 23, the U.S. Court of Appeals for the Second Circuit affirmed a district court ruling that Martin Shkreli, CEO of Vyera Pharmaceuticals (Vyera), violated federal and state laws by engaging in illegal and...more

Perkins Coie

FTC Signals Tough Line in First AI Discrimination Case Under Section 5

Perkins Coie on

The Federal Trade Commission (FTC) announced its first enforcement action alleging that discriminatory use of artificial intelligence (AI) was an unfair practice under Section 5 of the FTC Act on December 19, 2023. According...more

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