1. Pink Sheet
  2. >>Agency Leadership
  3. >>US FDA

First Amendment Does Not Block Off-Label Enforcement Actions, FDA Reiterates

 
• By Brenda Sandburg

Agency memo on manufacturer communications about unapproved uses says new court rulings and studies on off-label uses and adverse reactions support restrictions; whether agency’s new leadership has the same view remains to be seen.

FDAEntrance_1200x675

Responding to industry pleas for FDA to allow companies to share information about unapproved uses of their approved products, the agency issued a 60-page memo summing up its regulatory history and case law but offering no changes in its approach.

The memo, “Public Health Interests and First Amendment Considerations Related To Manufacturer Communications Regarding Unapproved Uses of Approved...

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
Start Free Trial

Already a subscriber?

More from US FDA

Hope For Stability, Credibility As US FDA Vet Pazdur Takes Over CDER

 
• By Sarah Karlin-Smith

The appointment of longtime FDA oncology leader Richard Pazdur to lead FDA's Center for Drug Evaluation and Research is being well received.

Makary’s Expert Panel Sparks Regulatory Action For Menopause Hormonal Therapy

 
• By Sarah Karlin-Smith

The requested changes to the class-wide warnings for hormone replacement therapies mark the first time one of Makary’s expert panels sparked regulatory action and could lead to broader scrutiny of their use.

Proposed Shutdown-Ending Agreement Would Cut US FDA Non-User Fee Funding

 
• By Derrick Gingery

But the Senate’s reduction would not be as much as the House of Representatives and President Trump proposed earlier this year, which is likely a win for the agency.

US FDA ANDA Priority Pilot ‘Practically Unusable’ Without Tweaks, AAM CEO Says

 
• By Sarah Karlin-Smith

Association for Accessible Medicines CEO John Murphy told the Pink Sheet that the FDA may need to consider phasing in the requirements for the new ANDA priority voucher incentive program if it wants sponsors to apply in the near-term.

More from Agency Leadership