Structured Risk-Benefit Framework Strikes Back: FDA Suvorexant Reviewer Cites Need for Real World Predictions

 
• By Cole Werble

A predictable risk-benefit framework for FDA drug approval decisions has been a long-term objective of many drug developers. A big step in that direction was adopted as part of the PDUFA V agreement last July. However, FDA's briefing documents for a review of a Merck insomnia therapy suggest that step may not be heading in quite the way that industry hoped.

The FDA team leader on the review of an important new Merck & Co. Inc. product (the insomnia drug suvorexant) has an interesting take on the agency’s developing framework for structured risk-benefit assessments in drug approval decisions.

To Division of Neurology Products' Ronald Farkas, the new instructions from Center for Drug Evaluation & Research management to reviewers...

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