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Accelerated Approval Drug Promotions Run Risk Of Overstating Efficacy, Understating Safety

 
• By Sue Sutter

Sponsors needs to think carefully about what to say in product promotions when clinical benefit has not yet been demonstrated, legal and regulatory experts said; such communications may or may not be able to leverage US FDA guidances on ‘consistent with labeling’ (CFL) and scientific information on unapproved uses (SIUU).  

Skunk
By promoting data from a confirmatory trial that was not conducted with due diligence, are sponsors poking the skunk of a new prohibited act under the FDCA? • Source: Shutterstock

Accelerated approval product sponsors need to take care that promotional materials neither overstate efficacy nor skimp on safety, and the US Food and Drug Administration’s new guidance governing scientific information on unapproved uses potentially creates both opportunities and risks when it comes to communicating about such products, experts said.

Key Takeaways

  • Accelerated approval on the basis of a surrogate or intermediate clinical endpoint, in the absence of a confirmed clinical benefit, creates special considerations for advertising and promotion, including requirements to submit promotional materials to the FDA before use.

At the Food and Drug Law Institute’s recent advertising and promotion conference, legal and regulatory experts discussed the unique promotional...

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