Partial Agreement in PDUFA Talks on Regulatory Science

FDA drug regulators and pharmaceutical industry representatives reached a partial agreement last month on several policy proposals under negotiations for the next reauthorization of the Prescription Drug User Fee Act (PDUFA), while leaving other issues unresolved for further talks.

According to just-released meeting minutes from a 1/8 session of the FDA-Industry Premarket Subgroup, the two sides agreed on draft commitment letter language covering drug development tools, including biomarker qualification, as well as benefit-risk assessment. FDA and industry negotiators said those elements of the industry’s proposal to incorporate regulatory science into decision-making could be closed out and removed from further negotiation.

However, discussions over improving FDA-sponsor interactions and meeting management remained unresolved. Industry representatives emphasized the importance of timely communication during drug development and said sponsors have already provided sufficient staffing and resources under PDUFA to support more frequent and efficient interactions, according to the minutes. FDA and industry failed to align on FDA’s proposed changes to meetings management and agreed instead to revert to the current framework established under the current PDUFA program.

A key area of ongoing debate involves industry’s proposal for multi-division review (MDR) meetings, which sponsors argue could reduce redundant interactions and improve consistency of regulatory advice. FDA acknowledged that sponsors already may request meetings involving multiple review divisions but cautioned that such meetings can require additional subject-matter experts, complicating scheduling and potentially causing the agency to miss performance goals.

Both sides agreed to continue discussions on defining characteristics for MDR requests to ensure consistent decision-making across FDA divisions, while keeping the approach within existing PDUFA meeting types. FDA said it would bring a counterproposal on industry requests related to converting meetings to written-response-only formats at a future session.

The subgroup also discussed industry’s proposal to facilitate first-cycle reviews, including the tracking of performance metrics. According to the minutes, FDA proposed new language to address information requests issued after late-cycle meetings, agreeing to describe the issue triggering such requests for sponsors’ reference. FDA also signaled general agreement with industry’s proposal for a third-party assessment of PDUFA performance, recommending that both sides align on a defined list of assessment topics.

Negotiators said the next meeting will focus on draft commitments related to real-world evidence, model-informed drug development, transparency, and patient experience data, as well as continued discussion of first-cycle review proposals.