News & Analysis as of

FDA Regulatory and Compliance Monthly Recap – November 2014

In an unusual move, the FDA takes issue with the accuracy of Sciecure’s studies in a warning letter over sales promotion material for the company’s sleeping pill - In addition to criticizing the pharmaceutical company...more

OIG Approves Manufacturer’s Direct-to-Patient Discount Sales Program

The Office of Inspector General (“OIG”) recently posted an Advisory Opinion approving a pharmaceutical manufacturer’s direct-to-patient product sales program. While this Advisory Opinion cannot be relied upon by anyone other...more

Mylan Pharms., Inc. v. FDA (N.D.W.V.)

Mylan filed a complaint on April 25, 2014, challenging a letter decision by the FDA, addressing the marketing exclusivity eligibility of celecoxib Abbreviated New Drug Application applicants. Mylan then filed a motion for...more

Recent FDA Draft Guidance Addresses Social Media Challenges Faced by Drug and Device Companies

The first draft guidance discusses how drug and medical device companies may promote their products using character space limited social media (e.g., Twitter) and Internet advertisements (e.g., Google search engine...more

FDA Proposes Guidelines for Posting Medical-Product Information Online

A lot can be misconstrued in the silent world of the Internet. While online technology has changed the communications paradigm, it also has resulted in bad information, embarrassing typos, factual errors and malfeasance....more

FDA Offers Guidance for Choosing Prescription Drug Names

If you've seen your share of prescription drug commercials, you've likely marveled at the odd drug names: Moexipril. Oxcarbazepine. Zafirlukast. You might think pharmaceutical companies just prefer complex, new combinations...more

FDA Issues Draft Guidance for Drug and Device Information on Social Media

On June 17, 2014, the FDA issued two draft guidance documents relating to the use of social media and the Internet to promote prescription drugs and medical devices. The FDA described how a company should use a character...more

FDA Issues Draft Guidance Docs On How To Provide Accurate Risk/Benefit Info in 140 Characters Or Less And Clean Up 3rd Party UGC...

Last Tuesday, the FDA issued two draft industry guidance documents advising pharmaceutical companies on how to accurately communicate information concerning prescription drugs and medical devices on social media and other...more

Putting Testosterone to the Test

Testosterone is the new big drug on the market. Marketed to men with ow T, a vague illness with even vaguer symptoms, there has been a recent explosion in its use. In line with this explosion are also the vast amounts of ways...more

Regulatory Risk: Pharmaceutical sector — clarification on approach to market definition for prescription medicines

SUMMARY - A decision handed down by the UK Court of Appeal earlier this month provides useful guidance on the correct approach to defining the market in relation to pharmaceutical products. The Court of Appeal held...more

HIPAA Marketing Rules Prompt First Amendment Challenge

In what is believed to be the first legal challenge to the HIPAA Omnibus Rule (the “Rule”), a vendor of prescription drug adherence services is seeking an injunction to block certain provisions of the Rule related to drug...more

News from Abroad: UK High Court Considers quia timet Injunctions

The UK High Court recently gave its judgment in the case of Merck, Sharp & Dohme Corp. and Bristol-Myers Squibb Pharmaceuticals Ltd (collectively referred to in the judgement as BMS) v Teva Pharma B.V. and Teva UK Ltd (Teva)...more

News from Abroad: Court of Appeal Refers Questions on Specific Mechanism to Court of Justice of European Union

Merck Canada Inc and Merck Sharp & Dohme Ltd v Sigma Pharmaceuticals plc - Prior to their accession to the European Patent Convention, several states did not allow patent protection for pharmaceutical products. To...more

Court Upholds Executive’s Conviction Stemming from Off-Label Drug Promotion

The U.S. Court of Appeals for the Ninth Circuit has upheld the wire fraud and misbranding convictions and sentence of InterMune Inc. founder W. Scott Harkonen. United States v. Harkonen, No. 11-10209 (9th Cir. March 4, 2013)....more

Dechert Survey of Securities Fraud Class Actions Brought Against U.S. Life Sciences Companies

Publicly Traded Life Sciences Companies in the United States Remain an Increasingly Popular Target of Securities Fraud Class Action Lawsuits: The past year was particularly noteworthy with respect to the absolute and...more

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

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

Ninth Circuit Affirms Conviction in Harkonen, Rejects the Defendant’s “Off-Label” First Amendment Challenge

On March 4, 2013, a panel of the United States Court of Appeals for the Ninth Circuit issued its opinion in United States v. Harkonen,1 a case in which the CEO of a pharmaceutical company was prosecuted for transmitting...more

Ninth Circuit Off-Label Marketing Decision Suggests More Prosecutions Will Be Coming

The Ninth Circuit has reopened a door for off-label marketing prosecutions, and it is important to review your compliance and risk management programs in light of this recent decision. Last December, the pharmaceutical and...more

FDA Regulation of Laboratory Developed Tests: Benefit or Unnecessary Burden?

The U.S. Department of Food and Drug Administration (“FDA”) has previously announced an interest in regulating diagnostic tests used in providing personalized medicine clinical care. Interested stakeholders such as the...more

Second Circuit Vacates Pharmaceutical Misbranding Conviction on Free Speech Grounds

After two years of deliberation, the U.S. Second Circuit Court of Appeals has finally issued its decision in United States v. Caronia, holding that the government cannot prosecute pharmaceutical manufacturers or their...more

Second Circuit Declares Off-Label Promotion Ban Unconstitutional: Implications for False Claims Act Defendants

On December 3, 2012, the United States Court of Appeals for the Second Circuit held that the First Amendment protects pharmaceutical companies who truthfully promote the lawful, off-label use of prescription drugs from...more

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

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

Second Circuit Vacates Off-Label Promotion Conviction on First Amendment Grounds in U.S. v. Caronia

On December 3, 2012, a panel of three judges on the U.S. Court of Appeals for the Second Circuit overturned the November 2009 conviction of Alfred Caronia for conspiracy to introduce a misbranded drug into interstate commerce...more

Off-Label Marketing Questioned as a Viable Criminal Theory – But Stay Tuned

On December 3, 2012, a divided Second Circuit held in United States v. Caronia (“Caronia”) that the misbranding provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”) do not criminalize “the truthful off-label...more

United States v. Caronia: Second Circuit Rules Manufacturers Cannot Be Criminally Prosecuted for Off-Label Promotion of Drugs...

On December 3, 2012, the United States Court of Appeals for the Second Circuit issued a landmark decision in United States v. Caronia, holding that “the government cannot prosecute pharmaceutical manufacturers and their...more

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