News & Analysis as of

Pharmaceutical Industry Dept. of Justice

AGG Food and Drug Newsletter - August 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Anti-Corruption Risks and Drug and Device Companies

by Michael Volkov on

For years, the Justice Department and the Securities and Exchange Commission touted the FCPA “sweep” of the pharmaceutical and medical device industries. With good reason, DOJ and the SEC turned the drug and medical device...more

Department of Justice Pilot Program Will Focus on Opioid Fraud and Abuse

by Arnall Golden Gregory LLP on

On August 2, 2017, Attorney General Jeff Sessions announced the formation of the Opioid Fraud and Abuse Detection Unit and a new Department of Justice (DOJ) data analytics program to combat opioid-related fraud and abuse. The...more

Nationwide Healthcare Prosecutions Targeting an Array of Practices . . . Is "Just The Beginning"

by Bracewell LLP on

On July 13, 2017, the Department of Justice ("DOJ"), in conjunction with the Department of Health and Human Services ("HHS"), continued its annual tradition of coordinating the filing of charges and sweeping arrests in...more

The State AG Report Weekly Update

by Cozen O'Connor on

Consumer Protection- 14 AGs Oppose Rollback of FCC Net Neutrality Protections- 14 Democratic AGs, led by Illinois AG Lisa Madigan, submitted comments urging the Federal Communications Commission (“FCC”) to ensure open...more

DOJ Settlement Looks to Set New Benchmarks for Suspicious Order Monitoring

by Ropes & Gray LLP on

This week, the U.S. Department of Justice and Drug Enforcement Administration announced a $35 million settlement with a major pharmaceutical manufacturer to resolve alleged failures to monitor and report suspicious orders for...more

Update on Regulatory Compliance in the Global Health Care Industry

by Baker Ober Health Law on

A comprehensive understanding of the constantly evolving layers that make up federal anti-corruption statutes, sanctions regulations and export control restrictions is imperative for both the pharmaceutical and health care...more

Healthcare Law Update: June 2017

by Holland & Knight LLP on

Medicaid - Florida's Medicaid Third-Party Liability Act Pre-empted by Federal Law - By Eddie Williams - In Gallardo v. Dudek, Sec. of Florida Agency for Health Care Administration, No. 4:16cv116-MW/CAS, 2017 WL...more

Global Inquiries into Drug Price Increases

European competition authorities announced this week an investigation into Aspen Pharmacare’s recent price hikes of five cancer drugs. The European Commission said in a press release that it had “information indicating that...more

The Responsible Corporate Officer Doctrine in the Wake of DeCoster

Executive Summary: The most important Park doctrine case in over forty years may be heading to the Supreme Court – but not if the federal government has its way. The Responsible Corporate Officer doctrine (“RCO doctrine”),...more

The Government Seeks to Intervene in its Third Generic Drug Price-fixing Lawsuit

Since we last reported on the state and federal government’s generic drug pricing investigations and litigations (click here to read more), the U.S. Department of Justice (“DOJ”) has obtained its first guilty pleas. On...more

Antitrust, Competition and Economic Regulation Quarterly Newsletter - Winter 2017

by Hogan Lovells on

FTC takes another look at merger remedies - On 3 February 2017, the U.S. Federal Trade Commission (“FTC”) released its Merger Remedies Study, which analyzed the success of merger remedies imposed by the FTC from 2006 to...more

Health Care Fraud and Abuse in the Middle District of Florida in 2016 - a Year in Review

by Carlton Fields on

The United States Attorney’s Office (USAO) for the Middle District of Florida (USAO-MDFL) prosecuted several civil health care fraud matters in 2016 and issued related press releases. A review of the USAO-MDFL’s criminal and...more

Corporate Investigations and White Collar Defense - February 2017

When Regulatory Failings Turn Criminal: Car Edition Redux - Why it matters: To paraphrase the famous quote from the film “All About Eve”: Fasten your seatbelts, it’s going to be a bumpy car ride. In the first part of...more

Dentons' pick of global regulatory trends to watch in 2017 - Competition/antitrust law

by Dentons on

Focus on the US - In the wake of the 2016 elections, we now await the decision as to who will be the "antitrust guard" at the top of the US Department of Justice (DOJ) and the Federal Trade Commission (FTC). At the...more

Top Ten International Anti-Corruption Developments for December 2016

by Morrison & Foerster LLP on

In order to provide an overview for busy in-house counsel and compliance professionals, we summarize below some of the most important international anti-corruption developments from the past month, with links to primary...more

AGG Food and Drug Newsletter - January 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

DOJ and SEC Close Out 2016 with a $520 Million FCPA Settlement

by Arnall Golden Gregory LLP on

The Securities and Exchange Commission (SEC) and Department of Justice (DOJ) wrapped up 2016 on December 22 with a near record-breaking Foreign Corrupt Practices Act (FCPA) settlement involving Teva Pharmaceuticals and its...more

The FCPA Enforcement Run Continues into 2017

by Michael Volkov on

Just when we thought 2016 was over and we could all breathe a sigh of relief, DOJ and the SEC have continued to run with a string of new enforcement actions. To all of those prognosticators, paparazzi, commentators, chicken...more

2016 Global Cartel Enforcement Report

by Morgan Lewis on

Authorities launched new criminal probes, obtained guilty pleas from companies and executives and imposed hefty fines as aggressive enforcement continued. Several significant developments occurred in cartel enforcement...more

Grassley Continues To Press CMS on Medicaid Drug Rebate Classifications: What Will Be the Fallout?

Back in early October, we were all transfixed by the announced Mylan settlement with the U.S. Department of Justice (DOJ) over Mylan’s alleged underpayments of Medicaid Drug Rebates for the EpiPen. Although Mylan indicated...more

Alert: Antitrust 2017: Trends and Developments to Watch

by Cooley LLP on

1. Transition to a Trump Administration is top of the agenda - President-elect Donald Trump's DOJ and FTC transition team appointments and public short list of candidates to run the agencies indicate that antitrust...more

Badda Bing, Badda Boom!! — DOJ and SEC Make 2016 a Record Year for FCPA Enforcement (Part I of III)

by Michael Volkov on

We begin the New Year with a three-part series on the FCPA: (1) A review of FCPA enforcement in 2016; (2) Trends from 2016 FCPA enforcement; and (3) Predictions for FCPA enforcement in 2017....more

Your Daily Dose of Financial News

by Robins Kaplan LLP on

The December 22 announcement that Deutsche Bank had settled with the DOJ over long-standing RMBS-related claims and investigations for a reported $7.2 billion prompted this Times long-read that traced the Icarus-like rise and...more

Teva FCPA Enforcement Action – Part II

by Thomas Fox on

Yesterday, I began an exploration of the Foreign Corrupt Practices Act (FCPA) enforcement action involving Teva Pharmaceuticals Industries Ltd. (Teva). It was brought jointly by the Department of Justice (DOJ) and Securities...more

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