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Addiction Recovery Medications' 'Stigma' Needs To Be Eliminated, Gottlieb Says

 
• By Michael Cipriano

US FDA commissioner tells House committee that culture changes – and label changes – are among the actions the agency is pursuing to address the opioid crisis.

This Is What Recovery Looks Like
• Source: T-shirt provided by Maine Alliance of Addiction Recovery

Hard policy changes by themselves won't be enough to combat the opioid epidemic, US FDA Commissioner Scott Gottlieb says, calling for the agency to facilitate a culture change around medications used for addiction recovery.

Testifying before the House Energy and Commerce Committee Oct. 25 on federal efforts on fighting the opioid crisis, Gottlieb announced...

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More from Legislation

Biktarvy, Trikafta Affected As Medicaid Cuts Could Increase Patient Assistance Demands

 
• By Cathy Kelly

Patient access to mental health drugs also will be challenged by the policies in the new budget reconciliation legislation.

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By Dave Wallace

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

Senate Bill Would Boost Oversight Of US FDA User Fee Program Following Trump Reorganization

 
• By Sarah Karlin-Smith

Senate appropriators also put FDA on notice regarding recent meetings and compliance with the Federal Advisory Committees Act, signal positive news on rare pediatric diseases, and offer hints of other agency areas they have close eyes on.

EU Ups Ante On Stockpiling For Crises

 
• By Francesca Bruce

The European Commission has published two new strategies on stockpiling that will improve the availability of critical medicines in times of crisis and reduce the EU’s dependance on suppliers outside the bloc.

More from Pink Sheet

Sponsors Asked, EMA Delivered: One Handbook To Navigate CTIS

 
• By Vibha Sharma

The European Medicines Agency has revised the sponsor handbook for the Clinical Trials Information System, bringing together guidance that was previously scattered across multiple platforms and documents to help sponsors navigate the trial process more efficiently.

Will Tidmarsh’s Industry Experience Translate As US FDA’s Chief Drug Regulator?

 
• By Sarah Karlin-Smith and Derrick Gingery

The long-time industry executive led several drug approvals but may have a lot to learn about the intimate details of application review and the Center for Drug Evaluation and Research.

Don’t Look Back: US FDA AdComm Offers No Flexibility For Rexulti’s Post Hoc Bid In PTSD

 
• By Bridget Silverman

The US FDA's Psychopharmacology Advisory Committee emphasized high standards over regulatory flexibility while turning down Otsuka's brexpiprazole plus serotonin for post-traumatic stress disorder based on conflicting Phase III trials and post-hoc Phase II analyses.