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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

Blog: Case to Watch: Amarin Pharma v. FDA

by Cooley LLP on

A potentially significant case being watched by the pharmaceutical industry is Amarin Pharma, et al., v. U.S. Food and Drug Administration, et al., Civ. A. 15-cv-3588 (S.D.N.Y.). The complaint, filed in May 2015, is a “First...more

"Defamation Claims Brought by Texas Health Care Providers Will Be Subject to Anti-SLAPP Act Requirements"

by Porter Hedges LLP on

Health care providers should keep in mind that virtually any suit alleging defamation or other harm from a “communication” relating to the provision of services by a health care professional will be subject to the demanding...more

AZ Supreme Court Holds AZ Legislators Have Standing to Challenge AZ Law, But Media Mischaracterizing the Lawsuit

by Williams Mullen on

It seems that the media have become so accustomed to polarizing the topic of Medicaid expansion that reporters seem incapable of truly assessing the issues objectively and reporting accordingly. This has happened recently...more

What’s Next for the FDA’s Draft Social Media Guidances?

by Dechert LLP on

As many of our life sciences clients know, 2014 brought long-awaited draft guidance documents from the FDA regarding three social media-related topics of interest. The FDA provided its much-anticipated views on...more

Status Updates - October 2014 #8

..Doctor in the mouse. What if you could input a list of your current symptoms to Google, and quickly be connected with a doctor for a brief consultation? For a limited trial period, Google seems to have set up such a system...more

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