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Enforcement Actions › Administrative Procedure Act › Pharmaceutical Industry

Cozen O'Connor

The State AG Report – 04.10.2025

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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: •Mylan Inc. Settles Opioid Epidemic-Related Claims for $335...more

Knobbe Martens

District Court Finds the FDA Reasonably De-listed Eli Lilly’s Weight Loss Drug From Drug Shortage List

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Congress authorized the FDA to determine whether a drug is “in shortage in the United States.” The FDA’s determination of a drug shortage triggers mechanisms designed to alleviate the shortage. For example, a determination of...more

McGuireWoods LLP

Fourth Circuit Upholds OIG Advisory Opinion Process

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On January 23, 2025, the United States Court of Appeals for the Fourth Circuit rejected a challenge to Advisory Opinion 22-19 (the “Advisory Opinion”) issued by the United States Department of Health and Human Services,...more

Ropes & Gray LLP

2024 FDA Enforcement Review: Quality and Transparency Remain Critical Concerns

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The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some cases, precedent-setting enforcement actions in 2024. The government continued to...more

Robinson+Cole Health Law Diagnosis

Delaware District Court Determines that HRSA Enforcement Letter Targeting 340B Program Restrictions Violates the APA

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A federal court in Delaware recently determined that the Health Resources and Services Administration (HRSA) – the federal agency responsible for administering the 340B drug pricing program – did not comply with the...more

Health Care Compliance Association (HCCA)

Hooper, Kearney and Macklin on Cutting Edge Topics in the False Claims Act

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While the pandemic put many things on hold, it did not do the same for the False Claims Act (FCA). To find out what is happening in FCA activity we spoke with Patrick Hooper, Jordan Kearney and Alicia Macklin, partners at the...more

Foley & Lardner LLP

Court Sides with Drug Manufacturers in Ongoing 340B Litigation

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Over the last year, covered entities participating in the 340B Drug Pricing Program (340B Program) have anxiously monitored a flurry of litigation that could determine the scope of the 340B Program. The litigation and related...more

Skadden, Arps, Slate, Meagher & Flom LLP

Skadden's 2020 Insights

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Despite political and economic uncertainties, markets and deal activity were resilient in 2019, and strong fundamentals remain in place heading into 2020. Companies continue to face a challenging litigation and enforcement...more

Arnall Golden Gregory LLP

It’s Déjà Vu All Over Again: FDA Sued Again in Off-Label Promotion Case

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To quote the late Yogi Berra, it must feel like déjà vu all over again for the Food and Drug Administration (FDA) (or, if you prefer, Crosby, Stills, Nash & Young’s song, “Déjà Vu” (“We have all been here before”)). Fresh off...more

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