News & Analysis as of

Enforcement Actions Pharmaceutical Industry Regulatory Violations

Cozen O'Connor

TX AG Prescribes Legal Action Against Eli Lilly for Alleged Kickbacks

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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

Troutman Pepper Locke

2024 State AG Year in Review

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State attorneys general (AGs) continue to play a pivotal role as innovators, shaping the regulatory environment by leveraging their expertise and resources to influence policy and practice. The public-facing nature of AG...more

Polsinelli

Recent Regulatory Actions Against Unlicensed Pharmacy Benefit Managers in West Virginia

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The West Virginia Office of the Insurance Commissioner (“WV OIC”) recently took regulatory actions against four unaffiliated Pharmacy Benefit Managers (“PBMs”) that were operating in West Virginia without a PBM license. These...more

Gardner Law

FDA Issues Numerous Warning Letters

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The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more

The Volkov Law Group

Justice Department Declines FCPA Prosecution Against Lifecore Biomedical Under Corporate Enforcement Policy

The Volkov Law Group on

The Justice Department has brought three corporate FCPA enforcement actions in 2023 (if you include the Ericsson DPA breach settlement).  With its recent announcement of a declination under the Corporate Enforcement Policy,...more

The Volkov Law Group

Taro, Sandoz and Apotex Pay $447.2 Million to Settle False Claims Act Liability for Price-Fixing of Generic Drugs

The Volkov Law Group on

The healthcare industry faces cascading risks – one risk flows to another with compounding financial results.  Three generic drug companies just experienced this cascading liability. ...more

The Volkov Law Group

Avanos Medical Pays $22 Million to Settle Criminal Mislabeling Charges for Surgical Gowns

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Avanos Medical, a global medical device company, agreed to pay $22 million to resolve criminal charges relating to its fraudulent misbranding of its MicroCool surgical gowns....more

Thomas Fox - Compliance Evangelist

Bribery Schemes from 2019 FCPA Enforcement Actions

In today’s blog post, I want to look at some of the more unusual bribery schemes from Foreign Corrupt Practices Act (FCPA) enforcement actions in 2019. Some of these schemes were not unusual but they were accomplished with...more

Thomas Fox - Compliance Evangelist

Top Five Department of Justice FCPA Enforcement Actions in 2019

Welcome to the 2020’s. The past decade helped shape both Foreign Corrupt Practices Act (FCPA) enforcement and corporate compliance programs. 2019 FCPA enforcements bore out many of the developments from the preceding years of...more

Robins Kaplan LLP

Financial Daily Dose 9.9.2019 | Top Story: Fed on Track to Cut Rates Again in September

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Friday remarks from Fed Chair Powell in Zurich confirmed the central bank’s dedication to keeping the US economic expansion on track and appear to have signaled the Fed’s plan to cut interest rates for a second time this...more

Hogan Lovells

FDA Shuts Down OTC Drug Manufacturer with Longstanding and Pervasive cGMP and Labeling Issues

Hogan Lovells on

On Tuesday, FDA announced the entry of a consent decree of permanent injunction against Keystone Laboratories, Inc. of Memphis, Tennessee for manufacturing OTC hair care and skin care products in violation of Current Good...more

Hogan Lovells

The Crackdown Continues:  FDA Takes Action Against Company And Its Autologous Stem Cell Product, Alleging Significant Safety...

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Last week, FDA published a January 3, 2018 Warning Letter issued to American CryoStem for marketing Atcell—an adipose tissue derived stem cell product—without FDA approval and for several drug current Good Manufacturing...more

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