Pharmaceutical, DOJ | JD Supra Law News

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

by Jonathan Sack | Morvillo Abramowitz Grand Iason & Anello P.C.... on 5/9/2013

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

by Quinn Emanuel Urquhart & Sullivan, LLP on 4/11/2013

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

Focus on Health Care Firms in FCPA Investigations

by Doreen Edelman | Baker, Donelson, Bearman, Caldwell &... on 4/10/2013

I am seeing a lot of interest from health care clients regarding the Foreign Corrupt Practices Act (FCPA). I usually stay away from this topic because so many others cover it in detail. However, I want to point out that in...more

Two New Developments in First Amendment Challenges to Off-Label Promotion: What's Next?

by King & Spalding on 3/14/2013

Following the Second Circuit’s marquee First Amendment ruling in the Caronia case, two recent developments demonstrate a shift in the battleground for First Amendment challenges to the prohibition on off-label promotion under...more

DOJ Recovers Up To $48 Million in False Claim Act Case Resulting From Whistleblower Report

by Sigal Mandelker, Massiel Pedreira | Proskauer - Whistleblowing & Retaliation on 1/24/2013

In yet another large recovery for the DOJ, on December 6, 2012, DFB Pharmaceuticals, and its subsidiary, Healthpoint Ltd., agreed as part of a settlement to pay up to $48 million to resolve allegations that Healthpoint caused...more

Skadden's 2013 Insights: Global Litigation

by Skadden, Arps, Slate, Meagher & Flom LLP on 1/21/2013

New legal ground is expected to be broken this year in areas of importance to companies and their directors, officers and executives. We see those developments coming from around the globe and defining the litigation...more

Are the Feds Enlisting FedEx to Police the Illegal Pharma Market?

by Jeff Ifrah on 1/4/2013

The government may be coming up with a new cost-effective measure to help balance the federal budget – enlisting private companies to do their policing. A 2011 settlement between the Justice Department and Google for $500...more

Three Important Lessons from the FCPA Guidance for Pharmaceutical and Medical Device Companies

by Michael Volkov on 12/5/2012

The US Chamber of Commerce “praised” the FCPA Guidance. The Chamber did not get what it wanted but it had to recognize that the FCPA Guidance was helpful for businesses. The FPCA Guidance provides important information for...more

New FTC/DOJ Position Will Require Heightened Regulatory Reporting of Pharma, Biological and Diagnostic Licenses -- October 25,...

by Loeb & Loeb LLP on 10/3/2012

The Federal Trade Commission and Department of Justice recently announced revisions to the Hart-Scott-Rodino (HSR) Act’s premerger notification rules to require enhanced reporting of transactions (including licenses) relating...more

GlaxoSmithKline Settlement Puts Healthcare Industry on Notice

by LEVICK on 7/3/2012

With the Justice Department’s announcement that GlaxoSmithKline will pay $3 billion in the largest healthcare fraud settlement in U.S. history, all drug companies – and any other businesses working in healthcare or...more

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Pharmaceutical › Dept. of Justice