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

 
• By Sarah Karlin-Smith
  
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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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