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First Amendment › Federal Food Drug and Cosmetic Act (FFDCA) › Off-Label Promotion

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 -
Dechert LLP

FDA Issues Revised Draft Guidance on “Off-Label” Communications to Health Care Providers – Expanded Scope, Yet Limitations Remain

Dechert LLP on

The FDA issued Revised Draft Guidance addressing communications by drug and device manufacturers about “off-label” uses of approved products. The Revised Draft Guidance supersedes FDA’s 2014 Draft Guidance on...more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 5

Mintz - Health Care Viewpoints on

In this post, I will be focusing on the intersection of off-label communications with government enforcement of health care fraud through the False Claims Act. Over the past eight years, the U.S. Department of Justice (“DOJ”)...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

Hogan Lovells

House Subcommittee on Health Opens Floor for Discussion of FDA Regulation of Off-Label Speech

Hogan Lovells on

The House Subcommittee on Health has announced a hearing entitled “Examining Medical Product Manufacturer Communications” for Wednesday, July 12, 2017, at 10:15am EDT, in which it intends to examine two discussion-draft bills...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

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

Skadden, Arps, Slate, Meagher & Flom LLP

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

Skadden, Arps, Slate, Meagher & Flom LLP on

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

Morrison & Foerster LLP

New Settlement Highlights FDA’s Diminishing Power Over Off-Label Promotion

Morrison & Foerster LLP on

In a surprising turn of events, Pacira Pharmaceuticals, Inc. and the Food and Drug Administration (FDA) announced that they have settled their dispute regarding the off-label promotion of Exparel, one of Pacira’s anesthetic...more

Skadden, Arps, Slate, Meagher & Flom LLP

"The Future of Government Regulation, Enforcement of Off-Label Promotion"

Skadden, Arps, Slate, Meagher & Flom LLP on

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

Perkins Coie

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

Perkins Coie on

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

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

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

Arnall Golden Gregory LLP

Life Sciences Companies and Free %$&*@# Speech

Arnall Golden Gregory LLP on

Irish and NI life sciences companies operating in the US likely are familiar with the concept of “off-label” promotion–providing information about drug/device uses that have not been cleared by the FDA (even where the FDA has...more

Ballard Spahr LLP

Pharmaceutical Companies Get Off-Label Marketing Victory

Ballard Spahr LLP on

Last week, a federal judge ruled that the Food and Drug Administration (FDA) cannot prohibit a pharmaceutical company from marketing its drugs for off-label uses if its claims are truthful and not misleading. This ruling,...more

Wilson Sonsini Goodrich & Rosati

District Court Holds That FDCA Does Not Prohibit and Criminalize Truthful Off-Label Promotion of FDA-Approved Prescription Drugs

Wilson Sonsini Goodrich & Rosati on

On August 7, 2015, the U.S. District Court for the Southern District of New York released its Amarin opinion addressing whether truthful, non-misleading off-label promotion of U.S. Food and Drug Administration (FDA)-approved...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

Cadwalader, Wickersham & Taft LLP

First Amendment And Off-Label Promotion – Prosecute What I Do, Not What I Say

Cadwalader, Wickersham & Taft LLP on

On December 3, 2012, the United States Court of Appeals for the Second Circuit vacated the conviction of Alfred Caronia (“Caronia”), who had been tried and convicted of participating in an unlawful conspiracy to introduce a...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

Mintz - Health Care Viewpoints

FDA Will Not Appeal Second Circuit Decision in U.S. v. Caronia

Mintz - Health Care Viewpoints on

After the Second Circuit’s split decision in U.S. v. Caronia, holding that truthful off-label marketing is protected under the First Amendment and thus cannot be prosecuted under the misbranding provisions of the Food Drug...more

Saul Ewing LLP

Second Circuit Jettisons Criminal Conviction for Pharma Rep Convicted for Off-Label Promotion

Saul Ewing LLP on

On December 3, 2012, the United States Court of Appeals for the Second Circuit overturned the conviction of a pharmaceutical sales representative convicted for misbranding in violation of the federal Food, Drug and Cosmetic...more

K&L Gates LLP

Off-Label Marketing Questioned as a Viable Criminal Theory – But Stay Tuned

K&L Gates LLP on

On December 3, 2012, a divided Second Circuit held in United States v. Caronia (“Caronia”) that the misbranding provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”) do not criminalize “the truthful off-label...more

Perkins Coie

In Landmark Decision, Second Circuit Reverses Conviction For Off-Label Promotion

Perkins Coie on

On December 3, 2012, in United States v. Caronia, a three-judge panel of the Second Circuit reversed a drug salesperson’s conviction for conspiracy to introduce a misbranded drug into interstate commerce, a misdemeanor...more

Morgan Lewis

First Amendment Prohibits Criminal Prosecution of Truthful Off-Label Promotion

Morgan Lewis on

Second Circuit holds that the government will be required to prove more than simple off-label promotion for misbranding prosecutions under the FDCA. On December 3, the U.S. Court of Appeals for the Second Circuit ruled...more

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