The Food and Drug Administration plans to host several advisory committee meetings this summer, including for investigational therapies from Replimune and Capricor Therapeutics, according to a July 27 announcement. The newly announced schedule follows a nine-month period without such meetings and reflects an evolving agency position compared to the previous year.
Industry and regulatory leaders are questioning whether the right experts are in place to ensure high scientific standards during these discussions. Peter Pitts, a former associate commissioner at the FDA responsible for advisory committees, said, “There’s a difference between having every seat on an advisory committee filled vs. having the right people in those seats.”
On July 29, the FDA’s Cellular, Tissue, and Gene Therapies advisory committee will discuss Capricor’s previously rejected Duchenne muscular dystrophy cardiomyopathy cell therapy deramiocel. The following day, the same committee will consider Replimune’s advanced melanoma drug RP1. The agency has until two days before each meeting to name its members. Nicholas Richardson, vice president of clinical development at Precision for Medicine and former FDA deputy director, said it is important to know which subject matter experts have been invited: “It’s hard to gauge in the absence of that, because right now on the [CTGTAC] there are only four standing members.” Richardson also called for continuity among committee membership.
The shift toward more frequent advisory committees comes after changes in FDA leadership. Former commissioner Marty Makary and former Center for Biologics Evaluation and Research director Vinay Prasad had reduced use of such committees after joining in spring 2025. Pitts said they disrespected not just the process but also “the experts who serve on them,” calling them “shills and tools of the industry.” He added, “Shame on the administration for allowing that to happen.” With both officials now departed from their roles earlier this year—and under interim Commissioner Kyle Diamantas—at least three new adcomms have been scheduled.
Capricor CEO Linda Marbán said she was surprised by her company’s meeting being scheduled: “We did hear that [acting FDA Commissioner] Kyle Diamantas . . . said he wanted more adcomms, and so we’re kind of wondering if this is sort of in response to that.” Marbán suggested increased caution around Duchenne muscular dystrophy therapies may follow controversial regulatory decisions involving Sarepta Therapeutics’ gene therapy last year.
Pitts warned against treating advisory committees as procedural formalities: “Treating advisory committees as a box to check is a huge mistake,” he said. Perry Sternberg, CEO of Sydnexis—which received an unexpected rejection for its pediatric myopia treatment—said his company welcomes rigorous discussion at future meetings but wants assurance about expert participation: “Please get people that understand myopia around the table.”
