Drugs

FDA Considering Industry PDUFA 8 Incentive Proposal

At the 2/26 PDUFA 8 reauthorization meeting, FDA said it would consider an industry counterproposal to the agency’s America First fee incentive proposal. Meeting minutes indicate that industry representatives said FDA’s proposed three-time fee differential would be “extremely punitive rather than an incentive for substantial changes to development decisions.”

The industry representatives said they believed the agency proposal would negatively affect the PDUFA program’s broader financial structure. They proposed that the fee for applications submitted in PDUFA 8 where the eligibility criteria for initiating Phase 1 trials in the U.S. are met, would be half of the full application fee. The representatives said such an approach would be feasible to implement and would provide an incentive while avoiding unnecessary punitive measures for programs in which initiating trials in the U.S. may not be feasible. The representatives also said their approach aligns with the existing fee structure, in which applications without clinical data also pay half of the full application fee.

The industry representatives further proposed that the two sides discuss process improvements that incentivize companies to conduct their clinical trials in the U.S. by streamlining the review of INDs. Agency representatives responded that FDA’s proposal is only related to financial incentives and that the agency is unlikely to consider process improvements beyond the topics already under consideration by the Pre-Market Subgroup. The industry representatives said they would provide specific suggestions for process improvements.

FDA and industry leads from the Pre-Market, CMC (chemistry, manufacturing, and controls), and Finance subgroups and the Steering Committee summarized their accomplishments and plans for next steps.

The Finance subgroup leads acknowledged disagreements in the subgroup about the use of PDUFA funds, and the two sides reiterated their commitment to reach an agreement.

The sides agreed to continue discussing FDA’s America First proposals and the non-orphan indication supplement fee proposal at upcoming meetings.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome