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

FDA Publishes Guidance on Off-Label Use Communications

The U.S. Food and Drug Administration (FDA) recently released two draft guidance documents and a memorandum related to off-label communications and the FDA’s power to regulate such communications. The publications are the...more

FDA Hardens Its Stance on Intended Use and Off-Label Use and Industry Responds

From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible....more

Beyond the Label: FDA Addresses Permissible Scope of Communications With Payors and Physicians

The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more

The First Amendment Does Not Protect All Off-Label Drug Promotion

FDA is considering making off-label promotion easier, consistent with recent case law. The drug and biologics industry is also proposing an ease up of FDA regulation, which would allow it to “responsibly” promote new drug...more

Guest Post – The FDA’s Two-Day Meeting on Manufacturer Off-Label Communications

Today’s guest post is by Liz Minerd, a Reed Smith associate, who closely followed the online feed of the recent FDA meeting that the Agency called to discuss what changes would be appropriate in its off-label promotion...more

Upcoming FDA Public Meeting on Speech and Medical Products

As a reminder, the Food and Drug Administration (FDA) is holding a two-day public meeting on November 9 and 10, 2016 regarding “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” ...more

Update on Prosecution for Truthful Off-Label Promotion

We have been following issues related to the interplay of off-label use, manufacturer statements about off-label use, the First Amendment, and FDA enforcement for a long time. (Like here, here, and here, among many posts.) ...more

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

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

Another Off-Label Promotion Third Party Payor Case Lacks Causation

July in D.C. is hot and sticky. When scorching day follows scorching day, area residents look forward to evening thunderstorms, not just to water otherwise thirsty lawns and gardens but to cool things down. Lightning can be...more

A Blow Against False Claims Act Liability For Off-Label Promotion

Recently, we noted that one of the first decisions we wrote a post about had been affirmed by the Second Circuit. Of the district court decision, we had penned “It is nice to see a judge with a proper understanding of how...more

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

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

Latest First Amendment Off-Label Notes - Has DoJ Finally Come Around?

As we mentioned before (when we provided a discount) Bexis spoke earlier this week at the ACI Promotional Review Summit on the “Brave New World . . . Post-Amarin” – that is to say, about the First Amendment and off-label...more

Food and Drug Newsletter - December 2015

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Happy Veteran’s Day/In Praise of Free Speech and a SD Fla. Decision

Yesterday was Veteran’s Day. This is a holiday that escapes the attention of too many people – until they stare at their empty mailboxes in puzzlement. It is a federal holiday, but most of us go about our usual business....more

First Amendment Notes: Amicus Briefs In Pacira & Application of IMS v. Sorrell

Here we discuss a couple of developments involving (actually or potentially) the application of the First Amendment to the FDA’s increasingly battered prohibition against truthful promotion of off-label use....more

Going on Offense against State Deceptive Trade Practices AG Actions

We have posted many times about cases where a manufacturer of a regulated product is sued over alleged violations of a state consumer protection or deceptive trade practices act because of something allegedly amiss in the...more

The FDA Tiptoes – and Congress Splashes Into – the 21st Century

Here are a couple of non-litigation related matters that we thought our readers need to know about. First, the FDA. We’ve pointed out before that the FDA’s “intended use” regulations for drugs (21 C.F.R. §201.128) and...more

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

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

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

First Amendment Right to Off-Label Promotion – Has Pandora’s Box Been Opened for FDA?

A handful of recent court decisions, including one issued just last month, seems to have potentially cracked open the door for pharmaceutical manufacturers to have more leeway to promote off-label uses of their products....more

Advertising Law - August 2015 #4

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

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

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

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

Pharmaceutical Companies Get Off-Label Marketing Victory

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

Blog: Significant Court Decision Issued Today re: Off-Label Promotion

A highly anticipated decision was issued today in the U.S. District Court for the Southern District of New York in the case, Amarin Pharma Inc. et al. v. Food and Drug Administration et al. (case no. 1:15-cv-03588). See this...more

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