First Amendment Off-Label Use

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 -
News & Analysis as of

New Reprint Guidance Maintains Bipartisan Status Quo

On February 28, 2014, the FDA issued its most recent unofficial guidance on distribution by manufacturers of research concerning off-label uses. With minor textual revisions, this new Guidance essentially restates the safe...more

Caronia And The First Amendment Defense To Off-Label Marketing: A Six Month Re-Assessment

When the Second Circuit issued its December 3, 2012 decision in United States v. Caronia, the opinion was proclaimed by many to signal a sea change in the prosecution of off-label promotion....more

Business Litigation Report -- April 2013

In This Issue: - Firm News: DoJ Star Healthcare Fraud Prosecutor Joins Washington, D.C. Office; and Quinn Emanuel Wins Top Honors at the Inaugural U.S. Benchmark Annual Awards - Main...more

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

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

Appeals Court Rejects Drug Company Executive’s First Amendment Defense and Upholds Wire Fraud Conviction

A three-judge panel of the U.S. Court of Appeals for the Ninth Circuit, in a recent unpublished opinion, upheld the conviction and sentencing of former InterMune, Inc. executive Scott Harkonen for wire fraud. In 2009, a jury...more

Ninth Circuit Affirms Prosecution for Off-label Marketing

Over the past two years, courts began to recognize that at least some off-label marketing is protected lawful commercial speech under the First Amendment. Specifically, the Second Circuit in New York in a case called United...more

Ninth Circuit Affirms Conviction in Harkonen, Rejects the Defendant’s “Off-Label” First Amendment Challenge

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

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

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

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

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

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

First Amendment Prohibits Criminal Prosecution of Truthful Off-Label Promotion

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

Second Circuit Vacates Misbranding Conviction for Pharmaceutical Representative on First Amendment Grounds

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

Second Circuit Court of Appeals Issues Blow Against Off-Label Promotion Enforcement

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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