Pharmaceutical Industry Dept. of Justice

News & Analysis as of

"Financial Relationships Likely to Be a Focus in Life Sciences Enforcement and Litigation"

For more than a decade, the Department of Justice (DOJ) has zealously pursued enforcement actions against the health care industry. Given the continued growth in government spending on health care and the billions of dollars...more

More on Patent Settlements Including Litigation at the European Courts

Last week I posted on the European Commission’s (EC) latest report into patent settlement agreements between originator and generic companies in the European Union (EU). The EC says each time it produces these reports that...more

Alert: Top 10 Antitrust Developments and Trends to Watch in 2016

Attention in the US during 2016 will be on the presidential campaign, and the election in November will bring a change in the "antitrust guard" at the top of the DOJ and FTC – even if a Democrat wins – that will drive the...more

FDA Regulatory and Compliance Monthly Recap — December 2015

Pacira secures expanded marketing for painkiller medication as FDA agrees to settle lawsuit, revoke warning letter - The pharmaceutical industry won in its latest bid for more leeway to promote drugs for unapproved uses,...more

"Key Takeaways: Fifth Annual Pharmaceutical and Medical Device Seminar"

On November 17, 2015, a group of Skadden attorneys and corporate counsel joined representatives from more than 20 life sciences companies to discuss U.S. enforcement issues companies throughout the industry face. The key...more

The Pharmacy Industry – 2015 Year In Review

With 2015 coming to a close, we wanted to provide a recap of the major updates impacting the pharmacy industry and what pharmaceutical manufacturers, pharmacy benefit managers (“PBMs”), and pharmacies might expect in 2016. ...more

DOJ’s Increased Scrutiny of Pharmaceutical Manufacturer and Specialty Pharmacy Ties

Over the past two years, the relationship between pharmaceutical manufacturers and specialty pharmacies has been under increased scrutiny by the U.S. Department of Justice (DOJ). Specifically, the DOJ has targeted industry’s...more

Principal Deputy Assistant Attorney General Mizer on Yates Memo: “No Partial Credit for Cooperation that Doesn’t Include...

Principal Deputy Assistant Attorney General Benjamin C. Mizer’s remarks at the 16th Pharmaceutical Compliance Congress and Best Practices Forum highlighted the Department of Justice’s “renewed commitment to ensuring that...more

Justice Department Charges Pharma President with Kickback Conspiracy

In the public relations battle following the issuance of the Yates Memo, the Justice Department can now cite one example for the new policy – the recent arrest and charging of Carl Reichel, former President of Warner...more

Yates Memo Discussed at Pharmaceutical Compliance Congress

As readers of Health Law and Policy Matters know, we have covered recent developments in the Department of Justice’s (DOJ’s) commitment to prosecuting individuals involved in corporate misconduct. A flurry of activity on...more

Principal Deputy Assistant Attorney General Mizer Sheds Additional Light on Individual Accountability and the Yates Memo

On October 22, 2015, the U.S. Department of Justice Principal Deputy Assistant Attorney General Benjamin C. Mizer, who oversees DOJ’s Civil Division, spoke at the 16th Pharmaceutical Compliance Congress and Best Practices...more

Health Law Pulse - October 2015

The Health Resources and Services Administration (HRSA) recently issued proposed omnibus guidance (Omnibus Guidance) interpreting various provisions of the 340B Drug Pricing Program (340B Program). The 340B Program allows...more

Expect Focus – International, Summer 2015

In This Issue: - TTIP’s Impact on U.S. and EU Trade Relations - Proposed Innovation Box Legislation - Justice Department Recovers Nearly $6 Billion From False Claims Act Cases in 2014 - Rules...more

Justice Department Recovers Nearly $6 Billion From False Claims Act Cases in 2014

The U.S. Department of Justice (DOJ) obtained a record $5.69 billion in settlements and judgments from civil cases involving fraud and false claims against the government in fiscal year 2014. This marks the first time the DOJ...more

Southern District of New York Finds Amarin Pharma, Inc.’s Off-Label Promotion Is Protected Speech; Company Cannot Be Prosecuted...

Pharmaceutical industry and constitutional buffs have been closely watching Amarin Pharma Inc. v. U.S. Food and Drug Administration. The case presented the (not wholly novel) question whether the First Amendment protects...more

Kmart Settlement Shows Breadth of Healthcare Practices Government Says Violate False Claims Act

A recent settlement by retailer Kmart Corp. illustrates the breadth of practices in the healthcare space that the government considers to be illegal kickbacks that violate the False Claims Act (FCA). The U.S. Department of...more

"The Future of Government Regulation, Enforcement of Off-Label Promotion"

Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more

Discriminating Tastes: Court Puts Long-running Robinson-Patman Act Case To Rest

Described as the Rodney Dangerfield of the antitrust laws, the Robinson-Patman Act—which prohibits anticompetitive price discrimination—gets no respect. The Justice Department and the Federal Trade Commission unapologetically...more

Washington Healthcare Update

This Week: House Energy and Commerce Subcommittee Holds Hearing on Legislation to Strengthen Medicaid Program Integrity and Fraud Controls... Bipartisan Senate Bill Introduced to Stop Anti-Competitive “Pay-For-Delay”...more

The Name Game Continues: AbbVie Files Supplemental Citizen Petition Raising Additional Concerns Regarding Biosimilar Labeling

AbbVie previously filed a citizen petition to the FDA arguing against its interim labeling requirements for biosimilars under the Biologics Price Competition and Innovation Act (“BPCIA”). In its supplemental petition, AbbVie...more

Red Notice Newsletter - August 2015

Welcome to the August 2015 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP. This month on the anticorruption front, the U.S. Department of Justice (DOJ) and the U.S. Securities and Exchange...more

How Far Is Too Far? Court Rules for Amarin in Off-Label Marketing Fight against FDA

Drugmaker Amarin Pharma, Inc. (Amarin), recently received a victory in its fight against the Food and Drug Administration (FDA). On August 7, 2015, the U.S. District Court for the Southern District of New York ruled that...more

The Government’s Generic Price-Fixing Investigation Targets Allergan’s Actavis Unit

This is our fourth post on the DOJ’s expanding investigation into possible price fixing by generic drug manufacturers. (Click here, here, and here to read our prior posts.) Since our last update, the DOJ has subpoenaed...more

The Deeper Dive: C-Suite to Prison Pipeline

In recent years, the U.S. Department of Justice (DOJ) has been criticized for failing to prosecute executives for fraud, particularly in the financial sector. In response, the DOJ has begun to more heavily emphasize...more

Federal Appeals Court Upholds FTC HSR Rule on Pharma Patent Licenses

Background – the HSR Act: Under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the HSR Act), acquisitions of voting securities, assets and other commercial interests which exceed certain monetary thresholds...more

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