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FDA Needs Formal Mechanism To Integrate Patient Input, Groups Say

 
• By Sarah Karlin-Smith

Although FDA says its drug reviewers are benefiting from the patient-focused drug development meetings under PDUFA V, stakeholders say a formal methodology is needed to incorporate patient input into the benefit-risk framework and drug review process.

FDA needs to create a transparent, formal methodology for incorporating information learned from patient engagement, particularly the PDUFA V disease-area meetings, into its drug review process while also alleviating barriers to industry interactions with patients earlier in the drug development process, stakeholders said during a Feb. 19 FasterCures webinar.

The first five patient-focused drug development meetings “have been great,” said Eric Gascho, assistant vice president of government affairs at the National Health Council

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