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Pharmaceutical Industry › First Amendment › Preliminary Injunctions

Mintz - Health Care Viewpoints

FDA Announces Dates for Long-Awaited Public Hearing on Its Regulation of Off-Label Communications

Mintz - Health Care Viewpoints on

Times, They Are A-Changin’ - On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including...more

Jackson Walker

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

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

Arnall Golden Gregory LLP

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

Arnall Golden Gregory LLP on

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

Latham & Watkins LLP

Amarin Settles Off-Label Promotion Case Against the FDA

Latham & Watkins LLP on

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

Mintz - Health Care Viewpoints

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

Mintz - Health Care Viewpoints on

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

Saul Ewing LLP

Southern District of New York Finds Amarin Pharma, Inc.’s Off-Label Promotion Is Protected Speech; Company Cannot Be Prosecuted...

Saul Ewing LLP on

Pharmaceutical industry and constitutional buffs have been closely watching Amarin Pharma Inc. v. U.S. Food and Drug Administration. The case presented the (not wholly novel) question whether the First Amendment protects...more

Cooley LLP

Blog: Trend Watch: First Amendment Challenges To FDA Promotional Requirements Continue

Cooley LLP on

In the wake of Amarin Pharma’s victory in securing a preliminary injunction against the Food and Drug Administration’s (FDA) prohibition of off-label communication of Vacepa , Pacira Pharmaceuticals has filed a First...more

Manatt, Phelps & Phillips, LLP

Advertising Law - August 2015 #4

Manatt, Phelps & Phillips, LLP on

In Case You Missed It: Possible Jail Time for TCPA Violations, Microsoft Gets Slammed With Solicitation Scam Class Action, and 'Do Not Disturb' Technology Gets Pushed on FCC - The world of the Telephone Consumer...more

Jackson Walker

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

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

Morgan Lewis

Practical Implications from Amarin

Morgan Lewis on

Amarin is an important US district court opinion affirming the importance of the Second Circuit’s Caronia decision and finding that pharmaceutical and medical device companies have a constitutionally protected right to...more

Cooley LLP

Blog: Significant Court Decision Issued Today re: Off-Label Promotion

Cooley LLP on

A highly anticipated decision was issued today in the U.S. District Court for the Southern District of New York in the case, Amarin Pharma Inc. et al. v. Food and Drug Administration et al. (case no. 1:15-cv-03588). See this...more

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