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Posting Preapproval Access Policies Could Help Prevent ‘Blame And Shame’ Under Right To Try

 
• By Sue Sutter

Many biopharmas have not publicly posted their policies for evaluating and responding to expanded access requests as required under the 21st Century Cures Act. Putting this information out will help set patient community expectations, but will not viewed by US FDA as off-label promotion, experts say at BIO annual meeting.

Biopharma companies that elect not to provide access to their investigational medicines under the new right-to-try law should publicly post their policies to help protect themselves from “naming and shaming” by unhappy patients, experts say.

Since the right-to-try law has removed FDA as a gatekeeper to preapproval access, companies will now bear all the blame...

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