Drug Promotion: Exclusivity Warrants Narrow Exception From Free Speech Protections

AbbVie and Daiichi tell US FDA that manufacturers’ communications should not be considered protected speech if they infringe exclusivity rights of other companies; comments seem aimed at restricting what competitors can say about protected claims for Humira and MorphaBond.

The First Amendment does not protect a drug manufacturer’s communications when the speech at issue could reduce the value of another company’s exclusivity, two pharmaceutical companies say.

In separate comments on an FDA draft guidance about medical product communications that are consistent with labeling, Daiichi Sankyo...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Marketing & Advertising

More from Compliance

‘Sex Pill For Women’: Sprout CEO’s Addyi Instagram Post Draws US FDA Warning Letter

 
• By 

Cindy Eckert’s social media post with a People.com story failed to include any risk information, made misleading representations about benefits and omitted material information about the indication, said the agency, which flagged similar concerns about an Addyi radio ad five years ago.

UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 

Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.

Novo, Lilly Ad Challenges Cause Discontinued Claims For Compounded GLP-1s

 
• By 

Two pharmacies, a medical spa and a telehealth company voluntarily removed efficacy, safety and quality claims for compounded GLP-1 products after innovator companies filed challenges with the National Advertising Division.