Pharmaceutical Industry First Amendment

News & Analysis as of

Off-Label Marketing – Industry Groups Step into the Breach

We have been waiting, literally for years, for the FDA to revise, clarify, update, or simply pay attention to, its off-label promotion regulatory position in light of repeated governmental First Amendment losses in Sorrell v....more

Business Litigation Report - July 2016

Article: Increase in Vertical Price Restraint Enforcement in China - In recent months, Chinese anti-monopoly enforcement actions scrutinizing and penalizing pricing-related issues have noticeably increased. A growing...more

A One-Two Punch Case With An Off-Label Twist

When we were young(er), we had a pretty good memory. It is not bad now, as far as we recall, particularly when it comes to pulling up bits of esoteric nonsense. For more important stuff, we find qualifiers like “vague” and...more

Another Off-Label Promotion Third Party Payor Case Lacks Causation

July in D.C. is hot and sticky. When scorching day follows scorching day, area residents look forward to evening thunderstorms, not just to water otherwise thirsty lawns and gardens but to cool things down. Lightning can be...more

In Limine Gag Orders – Can We Play, Too?

Lately, we’ve seen some plaintiffs add gag order requests to their complement of in limine motions in advance of significant trials. Those of us who participated in the Bone Screw litigation remember plaintiffs attempting –...more

Universal Health Services v. Escobar

On Thursday of last week, the Supreme Court for the first time addressed the “implied certification” theory of liability under the False Claims Act. The Court ruled unanimously that the theory is valid in certain...more

A Blow Against False Claims Act Liability For Off-Label Promotion

Recently, we noted that one of the first decisions we wrote a post about had been affirmed by the Second Circuit. Of the district court decision, we had penned “It is nice to see a judge with a proper understanding of how...more

Amarin Pharma Comes Out on Top in Federal Case Involving Freedom of Speech

The U.S. Food and Drug Administration (FDA) received another blow to its ability to regulate pharmaceutical product marketing that was dealt via a court order stating it is not in the agency’s purview to control promotional...more

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

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

Will Big Pharma’s free speech rights trump FDA, regulatory safety?

Recent developments in the law may have opened a new path for drug makers to exercise corporate free speech rights in ways that don’t look healthy for consumers. The case that concerns health watchdogs started when...more

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

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

AGG Food and Drug Newsletter - March 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Examining The Amarin/FDA Off-Label Promotion Settlement

A lot of firms have already expended a lot of ink discussing the proposed memorandum of settlement filed on March 8, 2016 in Amarin Pharma’s First Amendment litigation against the FDA We’ll try not to be repetitive of what...more

Fight the Good Fight Every Moment: Do Recent First Amendment Court Developments Deal a Blow to the Government?

In the last month, the Food and Drug Administration has suffered setbacks relating to off-label promotion oversight. In both cases, one involving a pharmaceutical company and the other a medical device firm and its Chief...more

Off-Label Enforcement Developments (Vascular Solutions, Inc. Acquittal and Amarin Settlement)

Two important cases involving the permissible scope of speech regarding off-label marketing recently resolved in ways that should bolster efforts by drug and device manufacturers to secure their First Amendment rights to make...more

Amarin Settles Off-Label Promotion Case Against the FDA

The Amarin settlement represents another important development in the FDA’s enforcement of off-label promotion. On March 8, 2016, US District Court Judge Paul A. Engelmayer entered a Stipulation & Order of Settlement in...more

Amarin/FDA Settlement: A Significant First Amendment Victory for Off-Label Marketing

On March 8, 2016, Amarin Pharma, Inc. and FDA entered into a formal settlement, close to a year after the U.S. District Court for the Southern District of New York granted a preliminary injunction against FDA’s threats to...more

Amarin Pharma Settles First Amendment Claims Against FDA: Potential Implications

Irish drug company Amarin Pharma, Inc. (Amarin) and the U.S. Food and Drug Administration (FDA) agreed, on March 8, 2016, to settle claims that FDA regulations barring Amarin from making “truthful” and “non-misleading”...more

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

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 Proposed End to “Amarin Pharm v. FDA” has FDA Agreeing to Abide by District Court’s Order

We have been closely following Amarin Pharm, Inc. v. FDA with respect to the preliminary injunction granted by the Southern District of New York that prohibited the FDA from taking action against Amarin over truthful,...more

"One-Two Punch: Amarin Settlement Order and Vascular Solutions Acquittal Further Erode Off-Label Promotion Enforcement Regime"

In an apparent first, the U.S. Food and Drug Administration (FDA) has conceded that a pharmaceutical company may engage in truthful and nonmisleading speech promoting the off-label use of a prescription drug. This concession...more

"Financial Relationships Likely to Be a Focus in Life Sciences Enforcement and Litigation"

For more than a decade, the Department of Justice (DOJ) has zealously pursued enforcement actions against the health care industry. Given the continued growth in government spending on health care and the billions of dollars...more

Ropes & Gray Advises Pacira Pharmaceuticals in Reaching Landmark Settlement Agreement with FDA

A cross-disciplinary team of Ropes & Gray attorneys advised Pacira Pharmaceuticals on its December 14 settlement agreement with FDA. On behalf of Pacira, Ropes & Gray had filed suit against FDA in September 2015 in the U.S...more

Food and Drug Newsletter - December 2015

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

First Amendment Notes: Amicus Briefs In Pacira & Application of IMS v. Sorrell

Here we discuss a couple of developments involving (actually or potentially) the application of the First Amendment to the FDA’s increasingly battered prohibition against truthful promotion of off-label use....more

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