Account

Sign in to access your account and subscription

Off-Label Promotion and Product Liability Considerations

It is well documented that government bodies are scrutinizing companies' promotional efforts, particularly marketing of products for unapproved uses, commonly referred to as 'off-label promotion.' Of course, it is important for any company to consider the regulatory implications of disseminating off-label information. However, it is shortsighted for companies not to consider potential product liability implications of off-label promotion.

22 minute readSeptember 28, 2007 at 02:10 PM
By
Alan G. Minsk
David Hoffman
Off-Label Promotion and Product Liability Considerations

The Food and Drug Administration ('FDA') prohibits the pharmaceutical industry from promoting products for off-label uses, unless certain prescribed statutory and regulatory requirements are met. A company may choose, although ill advised, to ignore this regulatory prohibition and admonition, but it must consider what happens when unfavorable events occur.

This premium content is locked for LawJournalNewsletters subscribers only

ENJOY UNLIMITED ACCESS TO THE SINGLE SOURCE OF OBJECTIVE LEGAL ANALYSIS, PRACTICAL INSIGHTS, AND NEWS IN LawJournalNewsletters

  • Stay current on the latest information, rulings, regulations, and trends
  • Includes practical, must-have information on copyrights, royalties, AI, and more
  • Tap into expert guidance from top entertainment lawyers and experts

Already have an account? Sign In Now

For enterprise-wide or corporate access, please contact Customer Service at [email protected] or call 1-877-256-2473.

NOT FOR REPRINT

© 2026 ALM Global, LLC, All Rights Reserved. Request academic re-use from www.copyright.com. All other uses, submit a request to [email protected]. For more information visit Asset & Logo Licensing.

Continue Reading

Letter Agreement Between Landlord and Tenant Did Not Extinguish GuarantyTreble Damage Award Upheld; Landlord Failed to Establish Overcharge Was Not WillfulDenying Access to Landlord Constituted Breach Entitling Landlord to PossessionTenant Entitled to Yellowstone Injunction With Respect to Taxes and Sewer Charges

March 01, 2026

New York is one of the first states to adopt laws to regulate artificial intelligence use in advertising and to strengthen post-mortem publicity rights regarding AI-generated replicas and “synthetic performers.” Given the state’s role as a bellwether for consumer-protection and advertising regulation, these new laws, combined with the state’s broader AI legislative framework, represent a shift toward transparency, consent and accountability.

March 01, 2026

State app store age verification regimes do more than reallocate responsibility between platforms and developers. They create a new data supply chain for age knowledge, one that can move COPPA questions from “do we ask age?” to “what do we do when the platform tells us?” The teams that handle this best will treat platform age signals as sensitive compliance inputs: minimize them, tightly control where they flow, and design product behavior so that minors do not trigger unnecessary collection or disclosure.

March 01, 2026

The firms leading right now chose to ask what would become possible if they managed the entire revenue lifecycle — from invoice generation to cash receipt — in one place, and what AI could actually accomplish with complete data instead of partial feeds. That is the Power of One.

March 01, 2026

A recent decision from the U.S. District Court for the Southern District of New York (SDNY), United States v. Heppner, has generated outsized commentary suggesting that the use of generative AI tools may jeopardize attorney-client privilege. A closer reading shows something far less dramatic.

March 01, 2026