While some analysts consider the return of advisory committees a positive sign for the FDA—and the biopharma industry more widely—others are keeping their optimism in check, waiting instead for more foundational changes at the regulator.
On April 30, a nine-month drought at the FDA will come to an end.
For the first time since July 2025, the regulator will convene external experts to deliberate on two cancer drug applications from AstraZeneca. These advisory committees—or adcomms, as they are commonly called—are typically assembled when the FDA needs to sort out certain scientific or technical issues with an investigational product. Ultimately, they provide the agency with independent expertise on whether or not an application is worthy of approval.
“When the agency faces novel trial designs or surrogate endpoints, the adcomm serves as its sounding board,” Paul Romness, CEO of OS Therapies, explained to BioSpace in an email.
The FDA is not required to follow the recommendations of its adcomms, though it often does.
That was the case at the last drug-focused meeting in July 2025, during which advisors discussed mixed late-stage data for Otsuka Pharmaceutical and Lundbeck’s bid to expand their atypical antipsychotic Rexulti into post-traumatic stress disorder (PTSD). The external experts voted 10–1 that the companies had not sufficiently established Rexulti’s efficacy in PTSD. In September, the agency rejected Otsuka and Lundbeck’s application.
Advisory committee meetings have been absent ever since—possibly indicating a move toward more unilateral decision-making at the FDA.
“The emphasis on fiat decision-making over the last year has been a counter and unwelcome change,” Steven Grossman, president of the regulatory consulting firm HPS Group, told BioSpace in an email. Adcomms are a “core component” of how the FDA works and how the agency can keep its decisions transparent to policymakers, the industry and the public more broadly, Grossman said—something currently in high demand from stakeholders, including the Institute for Clinical and Economic Review.
Notably, the FDA has held adcomm meetings since the Otsuka/Lundbeck panel, but their focus hasn’t been on drug applications. The FDA’s vaccines advisors, for instance, met twice—once in October 2025 and again last month—to discuss strain selection for the upcoming immunization seasons.
These meetings are part of the agency’s DNA, Grossman said, which includes a strong commitment to publicly weighing differing viewpoints before reaching a decision—something he noted has been largely absent from the agency for nearly a year now.
A social license
Beyond providing the FDA with independent scientific input, adcomms “provide a vital social license” for the regulator’s decisions, Romness said, particularly when it comes to what he called high-stakes drugs and controversial applications.
Rob Albarano, partner at the management consulting firm Arthur D. Little, agreed. “[Adcomms] establish transparency and credibility,” he told BioSpace in an email, noting that these meetings allow for public deliberations, which in turn provides a platform for stakeholders to see how evidence is weighed and how decisions take shape.
By promoting transparency, adcomms also create accountability, Albarano continued—a point that Grossman doubled down on.
“If you think they got X policy or Y product approval wrong, there is often a public record and many times that is the advisory committee transcript,” he said.
Advisory committee meetings provide a highly visible approach to regulatory decision-making, Grossman continued. This not only minimizes controversies and promotes broad acceptance of the FDA’s verdicts, but also reinforces its reputation as fair and credible, he said.
What does that say, then, about the agency when adcomms have been conspicuously absent over the last nine months?
“The decline in advisory committee activity appears to reflect broader institutional strain at the Food and Drug Administration, while also contributing to that strain,” Kristina Capiak, an associate director at Arthur D. Little, told BioSpace in an email.
“The administration appears to have taken a more restrictive stance on conflicts of interest, particularly by limiting participation from individuals with industry ties,” she said. In April 2025, FDA Commissioner Marty Makary moved to limit participation from pharmaceutical company employees during adcomms.
And while Capiak said that goal is understandable and even admirable in theory, in practice “it may have reduced access to specialized expertise at a time when the agency was already managing staffing constraints.”
Speaking of those constraints, Capiak also pointed to the continued “leadership instability” at the FDA as a potential driver behind the recent lack of adcomms.
“Repeated transitions can disrupt priorities,” Capiak said. “Advisory committees require planning, staffing, and consistent leadership. When those fundamentals are under pressure, these meetings are often among the first functions to contract.”
Indeed, since the start of the second Trump administration in January 2025, several stalwarts have left the agency. At the Center for Biologics Evaluation and Research, for instance, previous chief and cell and gene therapy champion Peter Marks was succeeded by Vinay Prasad, a controversial figure whose tenure as CBER director has been marked by regulatory inconsistencies and intermittent service. Prasad is set to leave the FDA by the end of April.
Meanwhile, the Center for Drugs Evaluation and Research has been even more unstable. Current acting director Tracy Beth Høeg is the fifth person to head the division in the past 16 months.
OS Therapies’ Romness suggested that Makary’s push to modernize the FDA and increase the agency’s focus on efficiency and operational speed through rolling submissions and real-time reviews “often favors internal expertise to avoid the logistical bottlenecks of traditional, resource-intensive public hearings,” he said. “When the FDA’s internal teams leverage these integrated assessment tools, they often reach a definitive yes or no long before a public meeting can be coordinated.”
Adcomms, then, may have gotten lost in the chaos of a White House transition and buried in the FDA’s rush to optimize its operations. In the process, the experts who spoke to BioSpace agree, the FDA has wounded its image in the eyes of the industry and the public—potentially triggering this renewed interest in holding an adcomm. The agency may be coming to this conclusion.
“We are seeing a realization at the highest levels that for controversial or first-in-class therapies, public transparency is one of the most effective ways to safeguard the agency’s reputation,” Romness told BioSpace.
A “narrow” restart
The FDA’s back-to-back adcomm meetings on April 30, scrutinizing two cancer drug applications from AstraZeneca, would seem to be a positive step toward recapturing this transparency.
The first session is focused on camizestrant, an oral SERD being proposed for the first-line treatment of HR-positive, HER2-negative breast cancer in combination with Pfizer’s Ibrance or Novartis’ Kisqali.
Camizestrant is backed by Phase 3 data demonstrating a significant improvement in progression-free survival. In a March 6 note, however, analysts at Leerink Partners flagged remaining doubt that earlier intervention imparts long-term benefit to patients “rather than front-loading a benefit that could have eventually occurred in a later line.”
The second application is for AstraZeneca’s AKT blocker Truqap, which the pharma is hoping to expand into metastatic hormone-sensitive prostate cancer. This bid is backed by the Phase 3 CAPItello-281 study, which showed that when combined with abiraterone, Truqap significantly improved radiographic progression-free survival (rPFS). A separate late-stage trial, however, was terminated after an external data board found that it was likely to fail its dual primary endpoints of rPFS and overall survival.
HPS Group’s Grossman is cautiously optimistic about the meeting and what it could mean for the FDA more broadly, specifically a possible return to “a process- and precedent-based approach to governing,” in which the use of adcomms is an important factor.
Arthur D. Little’s Albarano and Capiak are more skeptical.
“April 30 is a restart in a narrow sense,” Albarano said, in that it represents the first adcomm held in nine months. “That is significant,” he conceded. “On its own, however, it does not yet signal a durable shift.”
The true signal of change at the FDA will be continuity, Albarano said. Several drivers of the slowdown still seem to be in place, he said, “including leadership skepticism toward advisory committees.” The agency’s leadership roster is still far from stable, he added, and its pool of outside, independent experts remains shallow.
“Until those conditions change in a visible way,” Albarano said, “it is premature to call this a return.”
