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FDA Looking To Boost Transparency On How Patient Input Is Used In Drug Reviews

 
• By Sarah Karlin-Smith

Sponsor concerns about commercial confidential information may be a sticking point in getting patient groups the desired data on when and how the FDA uses patient input in regulatory decision making.

close up of gloved hand holding a scalpel
FDA could use a "scalpel" to carefully address commercial confidentiality and share more information with patient groups, an ultra rare disease advocate told the agency. • Source: Shutterstock

The US Food and Drug Administration is considering how to provide the public with more details on the use of patient-focused drug development (PFDD) information during drug reviews, while still navigating sponsors’ commercially confidential information protections.

Nicole Verdun, director of the Office of Therapeutic Products, acknowledged during a recent FDA-Duke Margolis Center for Health Policy public meeting on advancing the development of therapeutics through rare disease patient community

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