Account

Sign in to access your account and subscription

Off-Label Marketing and the First Amendment

Pharmaceutical and medical device manufacturers have argued that FDA restrictions on off-label promotion infringe their First Amendments rights. While First Amendment defenses are difficult, two recent cases have placed this issue back in the spotlight.

18 minute read May 27, 2010 at 10:17 AM
By
Jonathan S. Feld and Laura Brake
Off-Label Marketing and the First Amendment

Prosecutions for “off-label marketing” by manufacturers have become an important component of the government's health care initiative. “Off-label” usage of prescription drugs and medical devices refers to using a product for a purpose that is not specified in the labeling approved by the Food and Drug Administration (FDA).

This premium content is locked for Business Crimes Bulletin subscribers only

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

  • 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

The combination of increasing operating costs and uncertain government reimbursement funding continues to place health care providers under financial pressure, and in many cases, financial distress. Given the importance of Medicare/Medicaid funding of claims under provider agreements with the federal government, how courts interpret and apply the interplay between the Bankruptcy Code and Medicare Program Act determines the disposition of hundreds of millions of dollars of claims for reimbursement that support the health care system.

April 30, 2026

As AI becomes embedded in everyday business and legal operations, organizations are confronting a new expectation: simply disclosing AI use is no longer enough. A critical shift is taking place in the legal industry: transparency is no longer just about disclosure; it’s about comprehension.

April 30, 2026