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The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 5

In this post, I will be focusing on the intersection of off-label communications with government enforcement of health care fraud through the False Claims Act. Over the past eight years, the U.S. Department of Justice (“DOJ”)...more

Cyber Briefing: Second “Envelope” Lawsuit Against Aetna, Yahoo to Answer for 1.5 Billion Hacked Accounts and Eighth Circuit...

As we head into the new week, here’s a quick summary of major data security developments from around the country. Aetna Hit With Second “Envelope” Lawsuit - Aetna Inc. is now facing a second lawsuit over the disclosure...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 4

Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion. Not...more

Texas Dentistry Regulation Has No Teeth

by Faegre Baker Daniels on

A divided Fifth Circuit has affirmed a lower court ruling that an advertising restriction promulgated by the Texas State Board of Dental Examiners violates the First Amendment rights of the plaintiff dentists. The Texas...more

Ninth Circuit En Banc Panel Holds that Central Hudson Survives Sorrell

by Reed Smith on

Last week we bashed a Ninth Circuit Daubert decision. We feel a little bit bad about that, not because the decision wasn’t bashworthy – no, Wendell really is a rotten precedent – but because we hate contributing to the...more

NC Legislative Update: May 2017 #3

by Nexsen Pruet, PLLC on

This Week - Following the passage of the Senate budget proposal last week, the Senate had a fairly light calendar this week. The House continued to work while House budget writers draft their own budget proposal. The...more

Mobile targeting: A ‘secret weapon’ for good or ill?

by Thompson Coburn LLP on

It’s an advertiser’s dream — the ability to target customers through their mobile devices, right to down to where they are and what they are doing. But can such precisely targeted messages become a recipient’s nightmare?...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 1

As 2017 began, FDA appeared poised to implement significant changes to the rules governing off-label communications related to drugs, biologics, and medical devices. The Agency had hosted a public hearing in November 2016 to...more

FDA Hardens Its Stance on Intended Use and Off-Label Use and Industry Responds

From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible....more

FDA Issues Three Key Documents Relating to Medical Product Manufacturer Communications

by Ropes & Gray LLP on

On January 18, 2017, the Food and Drug Administration (“FDA”) released three key documents outlining the agency’s current thinking regarding drug and device manufacturers’ communication of information not contained in...more

FDA Holds Hearing on Off-Label Communications

After several high-profile defeats in both district and circuit courts involving the off-label promotion of regulated products and the First Amendment, the U.S. Food and Drug Administration (FDA) is now engaged in a...more

TCPA Update - October 2016

by Mintz Levin on

We are pleased to present the latest edition of Monthly TCPA Digest, bringing you insights on TCPA regulatory and legislative updates, class action developments, and trends. If you have suggestions for content you would like...more

Anti-SLAPP Statute Raised in Planned Parenthood Protest Lawsuit

by LeClairRyan on

The DC anti-SLAPP statute has been invoked in a Superior Court lawsuit in which plaintiffs arguing that students need to be free from disruptions in the school environment are facing off against anti-abortion protestors....more

Another Successful First Amendment Challenge to the Prohibition of Off-Label Promotion for FDA-Approved Drugs: Part Two

by Jackson Walker on

The Free Speech Clause notched another victory in the latest and, perhaps, final chapter of the lawsuit between the FDA and Amarin Pharma, Inc. concerning off-label marketing of an FDA-approved drug. On March 8, 2016, the FDA...more

FDA and Amarin Pharma Reach Milestone Settlement Allowing Off-Label Drug Promotion

by Foley Hoag LLP on

A milestone Settlement Agreement was reached March 8, 2016 between the Food and Drug Administration and Amarin Pharma, Inc. that expressly allows Amarin to promote its drug product, Vascepa®, for unapproved – i.e.,...more

FDA and Amarin Reach Settlement on First Amendment and Off-Label Statements

by Morgan Lewis on

FDA agrees to allow truthful and non-misleading off-label promotion. On March 8, the US District Court for the Southern District of New York approved settlement terms in connection with Amarin Pharma, Inc., et al. v....more

A New Year’s Resolution: Avoid The Rising Tide of Defamation Claims In The Health Care Arena

In college and graduate school, we all had professors that had “non-attribution/academic freedom” policies designed to foster open debate, critical thinking and robust discussion. To state the obvious, we are a long way from...more

EXPECT FOCUS: Onboard Technology, NAIC Cybersecurity, DOL, ACA Litigation, SEC Regulation (Vol. III, Summer 2015)

by Carlton Fields on

In This Issue: IN THE SPOTLIGHT - - Your Data Breach Collided With My Personal Injury Coverage LIFE INSURANCE - - Phantom Injury Dooms “Shadow Insurance” Case - Latest NAIC Cybersecurity News...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

Another Successful First Amendment Challenge to the Prohibition of Off-Label Promotion for FDA-Approved Drugs

by Jackson Walker on

The Free Speech Clause of the First Amendment prevailed in the latest challenge to the FDA's prohibition against marketing FDA-approved drugs for off-label (or non-FDA-approved) uses. Applying the Second Circuit’s...more

Another One Bites the Dust: FDA Doesn’t Like the Fishy Smell of the Latest Court Decision on Off-Label Dissemination

by Arnall Golden Gregory LLP on

In the most recent court decision, Amarin Pharma, Inc. v. United States Food and Drug Administration, No. 15 Civ. 3588 (PAE) (S.D. N.Y. August 5, 2015), a U.S. District Court granted Amarin's preliminary injunction to...more

Two Federal Circuit Courts Weigh In Ahead of Gomez

by Ballard Spahr LLP on

Just two months before the U.S. Supreme Court hears argument in Campbell-Ewald Co. v. Gomez, two federal circuit court panels have ruled on jurisdictional issues presented in the case. Both the Seventh Circuit in Chapman v....more

First Amendment Protects Truthful Off-Label Speech by Drug Manufacturers

Pharmaceutical manufacturers have likely taken note of Amarin Pharma Inc.’s recent success in a pre-enforcement legal challenge against the Food and Drug Administration (FDA or the Agency). On August 7, 2015, Amarin obtained...more

One Small Step for Amarin & One Giant Leap for Pharmaceutical Companies? - Only Time Will Tell

Friday’s ruling in Amarin Pharma, Inc. v. United States Food & Drug Administration is a monumental event. It signals the dawn of a new era for prescription drug promotion....more

FDA Files Brief Regarding Off-Label Promotion In Amarin Pharma Lawsuit

by Reed Smith on

As we mentioned in our prior post, the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit pending in the Southern District of New York raises interesting issues regarding the First Amendment and how it...more

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