PDUFA Proposal Satisfies Companies by Accelerating Drug Approvals

Trade organizations appear satisfied with the FDA’s proposed goals for the next iteration of PDUFA, citing a bevy of enhancements to drug development.

PhRMA and BIO — two organizations that took lead roles in the PDUFA negotiations — found the agency’s concerted effort to hasten drug approvals to be a significant gain for industry. The planned changes appeared in the proposal for performance goals and procedures to PDUFA when the current five-year cycle ends in September 2017.

Andrew Powaleny of PhRMA explained that the proposal would allow drugmakers to use patient-reported data, such as observing facial melanoma spots in the mirror, in regulatory submissions. This means more meaningful data for patients and drugmakers seeking approvals. He expects this data will specifically accelerate clinical development.