BioCentury
ARTICLE | Politics & Policy

BIO urges early risk-benefit collaboration

June 18, 2015 12:56 AM UTC

The Biotechnology Industry Organization released recommendations on Wednesday for drug sponsors to engage with patients and FDA early in drug development to reach consensus on benefit-risk frameworks for new drugs. BIO described the recommendations in a white paper entitled "A Lifecycle Approach to FDA's Structured Benefit-Risk Assessment Framework."

Under the terms of the PDUFA V agreement, FDA is implementing a framework that will attempt to standardize and make explicit its assessments of benefits and risks. The agency plans to provide copies of the framework to drug sponsors and the public only at advisory committee meetings and after approvals. But patient advocates and drug developers have told BioCentury they feel the framework would be much more valuable if they have opportunities to comment on it during drug development (see BioCentury, March 25, 2013). ...