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FDA Looking To Patient Advocates To Answer Benefit-Risk Questions

 
• By Kate Rawson

FDA’s clinical review teams are starting to approve novel drugs and biologics using a new structured benefit-risk framework developed under PDUFA V. Those assessments ask reviewers to think more broadly about the disease and how a new treatment might fit into the current treatment model. But many reviewers don’t have that information. And that, FDA says, is where patient advocates come in.

Read over any Food & Drug Administration review document from an office director or division director – the signatory authority that has the final say on whether a drug is cleared for marketing – and you’ll often see a pretty detailed discussion of the disease that a new drug or biologic is intended to treat, and how it fits into the existing armamentarium.

It’s clear that the leadership at each review division in the Office of New Drugs thinks about where a new treatment would fall in the current landscape when making regulatory...

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