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Free Speech › Federal Food Drug and Cosmetic Act (FFDCA) › First Amendment

Womble Bond Dickinson

Six Things You Need to Know About CBD and Other Hemp-containing Pet Products

Womble Bond Dickinson on

The trend toward state-level legalization of cannabis has led to a surge in cannabis-derived products and a continually evolving market with many types of cannabis products for people as well as their pets. Analysts predict...more

Troutman Pepper

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

Troutman Pepper on

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

Mintz - Health Care Viewpoints

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

Mintz - Health Care Viewpoints on

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

Skadden, Arps, Slate, Meagher & Flom LLP

"FDA Publications Double Down on Agency’s Ability to Prohibit Off-Label Communications, but Narrow Scope of Debate"

Skadden, Arps, Slate, Meagher & Flom LLP on

On the eve of a change in administration, the U.S. Food and Drug Administration (FDA or the Agency) released a flurry of documents regarding off-label communications and FDA’s ability to regulate such communications within...more

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

Arnall Golden Gregory LLP

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

Arnall Golden Gregory LLP on

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

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

King & Spalding

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

King & Spalding on

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

Holland & Knight LLP

Second Circuit Vacates Pharmaceutical Misbranding Conviction on Free Speech Grounds

Holland & Knight LLP on

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

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