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Public Outcry Over Generic Price Hikes Spurs Criminal Investigations

Drug manufacturers Impax Laboratories and Lannett Company have come under public scrutiny and, more recently, criminal investigation for their recent generic drug price increases. The companies disclosed in recent SEC filings...more

DOJ Investigation into Generic Pharmaceutical Pricing Signals Potential Criminal Exposure

The United States Department of Justice Antitrust Division (DOJ) recently served two U.S.-based generic pharmaceutical manufacturers with criminal grand jury subpoenas. It is reported that the subpoenas request all...more

Blog: Litigation Round-Up: Some Recent Drug & Device Settlements, Investigations, Inquiries

Settlements - Pharmaceutical company Organon Inc. agreed to pay $31 million to settle federal and state allegations that it underpaid Medicaid drug rebates, provided kickbacks to nursing home pharmacy companies,...more

The Houston Astros and a Compliance Defense in the FCPA

The Astros act like a corporation and like almost all corporations they look to pay the absolute cheapest that they can to get something. Those who advocate that there be a compliance defense added to the FCPA miss this...more

Red Notice Newsletter - July 2014

Welcome to the July 2014 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP. This month on the anticorruption front, two Noble Corporation executives settle with the U.S. Securities and Exchange...more

GSK Faces a Bad Day at Black Rock

One of my favorite movies is Bad Day at Black Rock. It is one of the few movies to combine elements of film noir into something approaching a traditional Western. It also attacks directly the prejudice and hate against...more

Red Notice Newsleter

Welcome to the May 2014 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP. This month, on the anticorruption front, Avon Products, Inc. (“Avon”) agrees to pay USD $135 million to settle a...more

Pharmaceutical Association Calls Out FTC in Filing Seeking to Enjoin New Rule Targeting the Industry

Last November, the Federal Trade Commission (“FTC”) with the “concurrence” of the Antitrust Division of the Justice Department, and over the strenuous objection of Pharmaceutical Research and Manufacturers of America...more

"Antitrust and Competition: Nonmerger Enforcement Activity Heats Up on Both Sides of the Atlantic"

U.S. and European antitrust agencies had similar enforcement priorities last year, a trend we expect to continue in 2014. Nonmerger enforcement will continue to focus on intellectual property, financial services and...more

"Antitrust and Competition: Surveying Global M&A Enforcement Trends"

US: Agencies Continue Aggressive Enforcement - Despite changes in leadership at the U.S. Department of Justice’s (DOJ) Antitrust Division and the Federal Trade Commission (FTC) (collectively, the Agencies) in 2013, the...more

Health Services Provider’s Settlement with DOJ Includes Detailed Factual Admissions and Agreement to Cooperate Against...

On January 8, 2014, pharmaceutical provider BioScrip, Inc. (BioScrip) reached a settlement with the Department of Justice (DOJ) to resolve claims under the False Claims Act (FCA) and the Anti-Kickback Statute (AKS), stemming...more

False Claim Act: 2013 Year in Review

Last year continued the trend of robust False Claims Act (FCA) enforcement by the U.S. Department of Justice (DOJ) and proliferating qui tam lawsuits brought by whistleblowers on behalf of the United States. In 2012, DOJ...more

Justice Department Announces $3.8 Billion In False Claims Act Recoveries In FY 2013

On December 20, 2013, the Justice Department announced a total of $3.8 billion dollars in settlements and judgments from civil cases involving the False Claims Act for Fiscal Year (FY) 2013. Total recoveries under the False...more

Antitrust and Competition Newsletter - December 2013

Japan’s METI Submits Amicus Brief in the TFT-LCD Litigation Seeking to Limit the Extraterritorial Reach of U.S. Antitrust Laws - On Oct. 31, 2013, Japan’s Ministry of Economy, Trade and Industry submitted a brief in...more

Antitrust agencies amend premerger notification rules to clarify reporting of certain acquisitions of exclusive patent rights in...

The US Federal Trade Commission, with the concurrence of the Antitrust Division of the US Department of Justice, has amended the premerger notification rules to clarify when a transfer of exclusive rights to a patent or part...more

FTC Announces Amendments to Hart-Scott-Rodino Rules Regarding Pharmaceutical Patent Licenses

The Federal Trade Commission (FTC) has announced revisions to the rules under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR) that will apply to certain transactions involving the transfer of patent rights in...more

FTC Broadens Notification Requirements for Transfers of Pharmaceutical Patent Rights

The Federal Trade Commission (FTC) has revised the rule for determining when a transfer of exclusive rights to a patent in the pharmaceutical industry (including biologics and medicine manufacturing) results in a potentially...more

FTC Issues Premerger Notification Review Changes for Pharmaceutical Patent License Transfers

The Federal Trade Commission (FTC) issued final changes to the premerger notification rules to expand the circumstances that require pharmaceutical industry companies to report proposed acquisitions of exclusive patent rights...more

J&J Will Pay $2.2 Billion and Enter 5-Year CIA to Settle Off-Label and Kickback Charges

This week, the DOJ announced that J&J has agreed to pay over $2.2 billion in civil and criminal fines in one of the nation’s largest ever health care fraud settlements. As part of the resolution, J&J subsidiary Jannsen will...more

The Glaxo-China Bribery Scandal: A New Policeman Walks The Beat

When it comes to allegations of foreign bribery, what a difference a week can make. Just over ten days ago, a new player in the world of international bribery – the Chinese Ministry of Public Security – announced that it was...more

Criminal Antitrust Newsletter - July 2013

INDUSTRY SCORECARD - E-books: Apple Inc.’s high-profile price-fixing trial ended in June, and the Court decided the case in the government’s favor recently. Some reports from the trial suggested that the case brought...more

Chinese Detain Pharmaceutical Company Managers in Economic Crime Probe

This week, reports have arisen that Chinese authorities in the cities of Shanghai, Beijing, and Changsha detained high-level GlaxoSmithKline (GSK) managers as part of an investigation into potential “economic crimes.” The...more

"Health Care Enforcement Update: What Is in Store for the Next Five Years"

While predicting enforcement trends over the next five years is not without uncertainty, the best marker for future activity may be to look to the past. We believe that industry members and counsel can expect the Department...more

Law Enforcement In The Health Care Industry: What Do New Cases Against Novartis Tell Us?

In recent years, pharmaceutical companies have faced criminal investigations and charges in regard to alleged off-label marketing of prescription drugs and kickbacks to doctors. For this reason, the filing last month of two...more

The First Amendment and Off-Label Promotion: United States v. Caronia

For years, the U.S. Department of Justice has aggressively pursued and brought charges over “off-label promotions”—the promotion of drugs for uses that have not received FDA approval—by pharmaceutical manufacturers and their...more

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