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Getting a Jump on PDUFA V: Fast Start on REMS, Patient Input – And Longer Reviews

This article was originally published in RPM Report

Executive Summary

The new Prescription Drug User Fee Act Program doesn’t take effect until October 1, but FDA has been getting moving on some key elements of the program since before the final negotiations began on Capitol Hill. FDA will need to move fast to meet the many policy deadlines set by the agreement negotiated with industry.

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Patient Advocacy And PDUFA VI: Next Steps Could Include Involvement In Reviews, More Scientific Briefings for FDA Staff

Disease advocacy organizations are expanding their “honest broker” function in drug development into the early stages of the regulatory discussions. They are engaging in the patient-focused meetings established by PDUFA V and finding more ways to interact with FDA review staff on general development issues in their specific areas. That may become the model for building on the patient input process in the next user fee agreement.

FDA Looking To Patient Advocates To Answer Benefit-Risk Questions

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.

PhRMA Wades Into FDA Patient-Focused Data Collection: Website Systems for Crowd-Sourced Info

Trade association partners with Genetic Alliance to provide input into FDA drug development initiative. That may be an effective intervention by PhRMA as it experiments with new ways to shape regulatory policy beyond traditional advocacy efforts.

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