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Puberty Blocker Petition Raises Questions About When FDA Should Weigh In On Off-Label Drug Use

 
• By Sarah Karlin-Smith

FDA is most often thought of as a regulator of off-label communication, but a new citizen petition on a contentious topic highlights the murkiness of the agency’s own obligations to discuss unapproved uses of drugs – particularly when effectiveness comes into play – and the challenges when medicine use becomes politically polarized.

view of an umpire standing behind a batter as pitch comes in during a youth baseball game
Citizen petition wants FDA to act as umpire in political debate over off-label use of puberty blocking drugs in children. • Source: Shutterstock

During the height of COVID it was not uncommon to hear top US Food and Drug Administration officials tell the public its role as a regulator of medical products is to “call the balls and strikes,” deflecting suggestions it operates with political ideology by saying it acts as a neutral arbiter of science.

Key Takeaways

  • FDA is being asked to help settle a contentious political debate with its scientific expertise.

But a new citizen petition related to the off-label use of puberty blocking drugs in children may test the...

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

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Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

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US FDA Skips User Fee Increase For More Staff Amid Exodus, Hiring Difficulties

 
• By Derrick Gingery

A calculation used to determine whether the FDA has the staff to handle its workload also was not included in the description of prescription drug user fee calculations.

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• By Neena Brizmohun

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England: Pharma Firms To Benefit From Parallel HTA And Regulatory Pathway

 
• By Eliza Slawther

The UK drug regulator and England’s health technology assessment agency have joined forces under an information sharing agreement, aimed at accelerating patient access to newly approved medicines by three to six months.