News & Analysis as of

Investigations Pharmaceutical Industry

Quarles & Brady LLP

A Prescription for Caution: Senators Release Investigative Report on Direct-To-Consumer Telehealth Models

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On July 17, the offices of Senators Durbin (D. IL.), Warren (D. MA.), Sanders (I. VT.), and Welch (D. VT.) (collectively, “Senators”) released a report summarizing the results of a nine month investigation into...more

Shumaker, Loop & Kendrick, LLP

Client Alert: Have You Looked at Who is Coming to Dinner and How It Impacts Your Compliance?

Several States' Attorneys General reported resolving a case alleging that Gilead Sciences ran an illegal kickback scheme to promote the use of its HIV medications. The government alleged that Gilead utilized various methods,...more

Barnea Jaffa Lande & Co.

Israel Competition Authority Intensifies Enforcement Measures and Indicts Schestowitz VP for a Suspected Cartel in the Food Sector

The Israel Competition Authority (ICA) conducted a thorough investigation of the S. Schestowitz Group, an Israeli company in the food and consumer goods sector, due to suspicions the company operated a cartel in the food...more

ArentFox Schiff

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

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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

Baker Donelson

New Section 232 Investigations Target Pharmaceutical, Semiconductor, and Critical Mineral Industries: What Impacted Businesses...

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The Department of Commerce (Commerce) has launched three Section 232 investigations covering pharmaceuticals, pharmaceutical ingredients, and their derivative products; semiconductors and semiconductor manufacturing equipment...more

Torres Trade Law, PLLC

Semiconductor Tariff Exclusions & New Section 232 Investigations

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This article provides an overview of the most recent tariff updates affecting businesses operating within the semiconductor, pharmaceutical, and critical mineral industries. Below we outline recent tariff exclusions for...more

White & Case LLP

Trump Administration Initiates Section 232 Investigations on Pharmaceuticals and Semiconductors

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On April 14, 2025, the US Department of Commerce Bureau of Industry and Security (BIS) announced the initiation of investigations into the effects on US national security of imports of pharmaceuticals and pharmaceutical...more

Bass, Berry & Sims PLC

13th Annual Healthcare Fraud & Abuse Review - 2024

Bass, Berry & Sims is pleased to announce the release of the 13th annual Healthcare Fraud & Abuse Review examining important healthcare fraud developments in 2024. Compiled by the firm's Healthcare Fraud & Abuse Task Force,...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 2nd - 4th, Orlando, FL

Get the latest insights in research compliance - The risks and challenges that come with clinical research are unique, as are the abundance of government regulations and enforcers that oversee them. HCCA’s Research...more

A&O Shearman

Consulting Firm Agrees To Pay $650 Million In A Deferred Prosecution Agreement

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On December 13, 2024, the United States Attorney’s Offices for the Western District of Virginia and the District of Massachusetts, along with the Department of Justice’s (“DOJ”) Consumer Protection Branch (collectively, “the...more

McDermott Will & Schulte

Bulletin Concurrence XII - Paris │Avril ● Mai ● Juin ● Juillet ● Aout 2024

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1. CONTENTIEUX - NOUVEAU RISQUE DE REMISE EN CAUSE À POSTERIORI D’OPÉRATIONS NON NOTIFIABLES - Par une décision du 2 mai 2024, l’Autorité de la concurrence (ci-après l’ « Autorité ») a fait pour la première fois...more

McDermott Will & Schulte

The Vifor Case: Disparagement Reloaded?

On July 22, 2024, the European Commission (EC) accepted commitments proposed by Vifor Pharmaceuticals to address disparagement concerns under Article 102 TFEU. This is the EC’s first pure disparagement case and its second...more

Health Care Compliance Association (HCCA)

‘If Only She Could Have Been Stronger’: Miami Trial Fraud Leads to Prison, Personal Loss

In September 2015, while working in an office on the grounds of Mercy Hospital in Miami, Ivette Maria Portela Martinez learned about an upcoming clinical trial for treatment of symptoms of Clostridium difficile infections and...more

Robins Kaplan LLP

The Robins Kaplan Justice Report - Vol. 18, No. 1

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Robins Kaplan Secures Historic $12.2 Million Settlement in a Section 1983 Jail Deliberate Indifference Case - Scott County Jail officials failed to report detained man’s injuries and allowed video evidence to be deleted. ...more

A&O Shearman

EU publishes summary of recent competition enforcement in the pharmaceutical sector and promises to continue policy of proactive...

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The European Commission (EC) has published its latest report on competition enforcement in medicines and medical products. Key takeaways are that: EU and Member State authorities imposed multiple material antitrust...more

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more

Health Care Compliance Association (HCCA)

Privacy Briefs: December 2023

Report on Patient Privacy 23, no. 12  (December, 2023) Northwell Health in New York and Cook County Health in Chicago each experienced impacts from a breach at Nevada-based transcription company Perry Johnson & Associates...more

Cozen O'Connor

DOJ Signals Increased Emphasis on Data Analytics to Prosecute FCPA Global Corruption

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On November 29, 2023, Department of Justice (DOJ or Department) policymakers announced explicitly that they are, for the first time, leveraging data analytics to help proactively identify and prosecute crimes in foreign...more

Sheppard Mullin Richter & Hampton LLP

Increased Enforcement in Healthcare? DOJ to Add More Prosecutors

An official from the Department of Justice (“DOJ”) recently announced the DOJ’s plans to “substantially” add to its current roster of 75 prosecutors specializing in healthcare fraud. On November 7, John “Fritz” Scanlon,...more

Robins Kaplan LLP

The Robins Kaplan Justice Report - Vol. 17, No. 2

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Minnesota Passes Survivorship Bill, Expanding Justice for Victims of Medical Malpractice and Wrongful Death - On May 20, 2023, Minnesota became the last state to pass a Survivorship Bill, expanding the damages that...more

Foley & Lardner LLP

FDA Encourages the Use of Decentralized Clinical Trials in New Draft Guidance

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On May 2, 2023, the U.S. Food and Drug Administration (FDA) released Draft Guidance regarding the implementation of Decentralized Clinical Trials (DCTs) for drugs, biological products, and devices. DCTs are clinical trials...more

Jackson Walker

Key Considerations for Clinical Investigators When Negotiating Clinical Trial Agreements

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Clinical trials are an essential component of the research architecture for developing new drugs and devices. Research institutions and their clinical investigators (“Investigators”) play an important role in supporting drug...more

Oberheiden P.C.

The FDA’s Scrutiny of Novo Nordisk is Likely to Trigger Additional Semaglutide Investigations

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Recently, the U.S. Food and Drug Administration (FDA) confirmed that it is investigating allegations that a 60 Minutes segment on the popular body weight loss drug Wegovy was actually an advertisement promoting the...more

Oberheiden P.C.

12 Keys to Surviving a Board of Pharmacy Investigation in 2025

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As a pharmacist, facing a board of pharmacy investigation can be extremely risky. While losing your professional license might seem like the greatest risk, this isn’t necessarily the case. Increasingly, boards of pharmacy are...more

White & Case LLP

Five Drug Pricing Issues to Watch in 2023

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Despite a busy 2022, drug pricing remains a hot topic at the federal and state levels, with a number of recent developments and trends worth monitoring heading into 2023. In the past year, the FTC increasingly focused on the...more

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