News & Analysis as of September 19, 2024

First Amendment › Federal Food Drug and Cosmetic Act (FFDCA) › Commercial 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... more +

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 -

Healthcare Law Update: July 2019

Holland & Knight LLP on 7/10/2019

CMS Regulation - District Court Strikes Down Rule Mandating Price Disclosure in DTC Pharmaceutical Advertisements - The U.S. Department of Health and Human Services (HHS), together with the Centers for Medicare &...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 Future of Government Regulation, Enforcement of Off-Label Promotion"

Skadden, Arps, Slate, Meagher & Flom LLP on 9/29/2015

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

Pharma and Medical Device Industry Victory in Off-Label Marketing Decision

Perkins Coie on 9/23/2015

The U.S. District Court for the Southern District of New York recently held that the FDA may not constitutionally bring a misbranding action based on truthful and non-misleading off-label promotion of an FDA-approved drug,...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

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

Arnall Golden Gregory LLP on 8/20/2015

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

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 Vacates Misbranding Conviction for Pharmaceutical Representative on First Amendment Grounds

Holland & Knight LLP on 12/6/2012

In United States v. Caronia, No. 09-5006-cr, slip op. (2d Cir. Dec. 3, 2012), the U.S. Court of Appeals for the Second Circuit held that "the government cannot prosecute pharmaceutical manufacturers and their representatives...more

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