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Enforcement Actions Reporting Requirements Pharmaceutical Industry

Goodwin

State Drug Transparency Laws - 2025 Update

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We previously reported on an uptick in the passage of state drug price transparency legislation. What follows is an update to that report. As of April 2025, approximately 23 states had passed drug price transparency laws....more

Goodwin

Pharma Manufacturer Federal Government Price Reporting: Recent Litigation and Settlements

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​​​​​​​Litigation involving drug price reporting under the Medicaid Drug Rebate Program (MDRP)  has been very active in 2022. Most recently, on August 3, 2022, an Illinois federal jury levied a $61 million verdict against Eli...more

Goodwin

Pharmaceutical Manufacturers Beware: New State Drug Transparency Laws and Enforcement Mechanisms Are Coming In 2022

Goodwin on

In 2016, states began passing pharmaceutical price reporting laws. These laws are designed to bring transparency to a pharmaceutical manufacturer’s drug pricing process by requiring drug manufacturers to report pricing and...more

Goodwin

Attention Pharmaceutical Manufacturers: New State Drug Transparency Laws and Enforcement Mechanisms Are Coming In 2022

Goodwin on

In 2016, states began passing pharmaceutical price reporting laws. These laws are designed to bring transparency to a pharmaceutical manufacturer’s drug pricing process by requiring drug manufacturers to report pricing and...more

Foley & Lardner LLP

Clinical Trials: Does FDA’s Notice to Acceleron Signal a New Era of Enforcement for Results Reporting?

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On April 27, 2021, the U.S. Food and Drug Administration (FDA) sent a notice of noncompliance to Acceleron Pharma (Acceleron), accusing the company of failing to post clinical trial summary results on its cancer combination...more

Skadden, Arps, Slate, Meagher & Flom LLP

Skadden's 2020 Insights

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

Herbert Smith Freehills Kramer

SEC-Mylan Settlement: The SEC Filed Suit Regarding Investigation Disclosure

On Sept. 27, 2019, the Securities and Exchange Commission (SEC) announced that Mylan N.V., a global pharma company that manufactures and sells EpiPen, which is used to treat serious allergic reactions, agreed to pay $30...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - September 2018

ANTICORRUPTION DEVELOPMENTS - Petrobras Settles with U.S. Authorities Over Alleged FCPA Violations - On September 27, 2018, the U.S. Department of Justice (DOJ) and the Securities and Exchange Commission (SEC)...more

Butler Snow LLP

Pro Te: Solutio Vol. 11 No. 1 – A Reflection on the First Ten Years

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It’s hard to believe a decade has passed since we delivered our first edition of Pro Te: Solutio to your door. Those years have brought enormous changes in the world and in our industry. Innovation has driven everything we...more

Cooley LLP

Blog: Vermont AG Announces Another Disclosure Law Enforcement Action

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the Vermont Office of the Attorney General (“VT AG”) previously published several enforcement actions taken against manufacturers of pharmaceutical, biological and medical devices for failing to comply with the state’s...more

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