Graham: PDUFA VIII reflects ‘America First’ principles
Officials from the US Food and Drug Administration (FDA) reaffirmed the administration's priorities in the proposed commitment letter for the Prescription Drug User Fee Act (PDUFA VIII) program during a public meeting on Wednesday.
With PDUFA VII ending at the end of FY 2027, the PDUFA VIII agreement, which was negotiated by FDA and industry over the last year, will shape FDA’s drug and biologics review programs from FY 2028-2032.
At the start of the meeting, FDA Deputy Commissioner Grace Graham discussed the some of the key policies mentioned in the commitment letter and the PDUFA VIII proposal the agency plans to submit to Congress by the January deadline.
She said that “America First is a top priority for this administration and a guiding principle. The recommendations before you today reflect that.”
FDA will review public comments from the meeting, make revisions, and submit the PDUFA commitment letter to Congress as part of the process to reauthorize the agreement. Comments must be submitted to the docket by 16 October 2026.
The Trump Administration has proposed various “America First” policies in its current term, and the PDUFA VIII agreement includes fee incentives to encourage drugmakers to conduct early-stage clinical trials in the US. Sponsors who include clinical trial data from at least one Phase 1 trial based in the US would only pay half of the premarket application fee for that submission. (RELATED: PDUFA VIII: FDA outlines goals, program enhancements in commitment letter, Regulatory Focus 13 August 2026)
Graham said the commitment letter also places a high priority on manufacturing readiness. “We want to make sure that the CMC [chemistry, manufacturing and controls] portion of the application is not a lagging indicator. It is heartbreaking for us and for sponsors when the clinical part looks good and we're ready to approve an application, and then an issue comes up on the quality side. We have to be confident that the product that is going to be approved and manufactured will deliver the results that the clinical data promises,” she said.
During the public meeting, regulators outlined the performance goals and program enhancements contained in the PDUFA VIII proposal spanning premarket drug review, postmarket safety, and chemistry, manufacturing, and controls (CMC) enhancements. Representatives from industry supported many of the changes proposed in the commitment letter.
“At a time when scientific innovation is rapidly advancing and international competition is intensifying, we believe that PDUFA VIII will continue to help facilitate and sustain a predictable, efficient, transparent, and science-based FDA regulatory review process that patients, industry and the broader healthcare ecosystem depend upon,” said Kristy Lupejkis, vice president and chief of staff at the Pharmaceutical Research and Manufacturers of America (PhRMA).
