News & Analysis as of September 21, 2024

Free Speech

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The First Amendment to the United States Constitution prohibits the government from making laws respecting the establishment of religion, prohibiting the free exercise of religion, abridging the freedom of speech or the press, preventing citizens from peacefully assembling, or interfering with citizens' ability to petition the government for redress of their grievances. The First Amendment is one of the most sacred aspects of the American legal tradition and has spawned a vast body of jurisprudence and commentary. less -

Did Congress Intend to Criminalize Off-Label Promotion? One District Judge Suggests the Issue Is Ripe for Review

Troutman Pepper on 9/17/2020

A judge in the District of Massachusetts recently questioned whether Congress intended to criminalize off-label promotion through misbranding and adulteration statutes. In an order denying a Rule 29 motion brought by two...more

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

Mintz - Health Care Viewpoints on 8/14/2017

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

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 3

Mintz - Health Care Viewpoints on 6/22/2017

This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In this installment, I continue...more

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

Mintz - Health Care Viewpoints on 9/2/2016

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

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

Saul Ewing LLP on 10/2/2015

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

It’s Déjà Vu All Over Again: FDA Sued Again in Off-Label Promotion Case

Arnall Golden Gregory LLP on 9/22/2015

To quote the late Yogi Berra, it must feel like déjà vu all over again for the Food and Drug Administration (FDA) (or, if you prefer, Crosby, Stills, Nash & Young’s song, “Déjà Vu” (“We have all been here before”)). Fresh off...more

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

Jackson Walker on 8/27/2015

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

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

King & Spalding on 3/14/2013

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

Dechert LLP on 3/13/2013

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

Second Circuit Vacates Pharmaceutical Misbranding Conviction on Free Speech Grounds

Holland & Knight LLP on 2/1/2013

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 Court of Appeals Issues Blow Against Off-Label Promotion Enforcement

Dechert LLP on 12/4/2012

In a split decision today, a panel of the Second Circuit Court of Appeals overturned ? on First Amendment grounds ? the criminal conviction of a pharmaceutical sales representative who had promoted Jazz Pharmaceutical’s Xyrem...more

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First Amendment › Off-Label Use › Free Speech

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