Pharmaceutical Industry Dept. of Justice

News & Analysis as of

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

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

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

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

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

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

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

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

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

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)

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

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

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

U.S. Department of Justice Recovered More Than $4.7 Billion From Civil False Claims Act Cases in 2016

On December 14, 2016 the United States Department of Justice made its annual announcement of the amount of money recovered in civil False Claims Act settlements and judgments in Fiscal Year 2016. ...more

Your Daily Dose of Financial News

Streetwise traces Italy’s Banca Monte dei Paschi’s big-time current troubles to a meeting nearly a decade ago and the ill-fated deal reached there that’s led to the downfall of 3 (and probably 4) of the world’s biggest and...more

Aggressive Remediation: Embraer and JP Morgan

There is no question that the Justice Department has raised compliance program expectations in a number of areas. Whatever you may think about the efficacy or fairness of the FCPA Pilot Program, the Justice Department has...more

White Collar Crime Law Enforcement in a Trump Justice Department - 8 Predictions

After a conventional presidential campaign, determining the policy priorities and direction of the incoming administration with respect to the Justice Department’s white collar law enforcement responsibilities can be a...more

Top Ten International Anti-Corruption Developments for October 2016

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

Your Daily Dose of Financial News

Wells Fargo is well past the rain, the pouring, and even the flooding. So why not possible liability for its RMBS practices? As part of an SEC disclosure, the bank acknowledge that it’s “in discussion” with the RMBS Working...more

Your Daily Dose of Financial News

The CFTC’s reportedly investigating the interest rate swap activities of Citigroup and others. Swaps allow companies to “hedge against a rise or fall in interest rates on the debt that they issue or hold, with banks usually...more

Top Ten International Anti-Corruption Developments for September 2016

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

Key Takeaways: Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies

On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such companies and included...more

It’s Hunting Season. For Unicorns? Lawsuit Against Theranos Signals Trend In Investors Going After Late-Stage Start-ups

Last week brought more bad news for private blood testing company Theranos Inc., as San Francisco-based Partner Fund Management L.P. (“PFM”) launched a suit claiming that it was duped into making a $96.1 million investment in...more

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