FDA Advisory Committees Decline & Biosimilar Rule Changes
FDA faces scrutiny over a 63% drop in advisory committee meetings in 2025 and new moves to ease biosimilar development requirements in 2026.
The U.S. Food and Drug Administration faces mounting scrutiny over two divergent regulatory signals emerging from the agency in early 2026: a marked reduction in advisory committee meetings that has drawn concern from physicians, researchers, and patient advocates, and a concurrent move to ease development requirements for biosimilar medications in an effort to reduce drug costs. Taken together, the two shifts illustrate the uneven terrain of federal drug regulation under Commissioner Marty Makary.
Advisory Committee Meetings in Decline
The FDA convened 14 advisory committee meetings in 2025, a figure that represents a decline of more than 63% from the 38 meetings held in 2024 and a notable drop from the 29 held in 2023. Meetings specifically related to drug approvals fell by 72% over the same period. The reduction has generated substantial concern among those who view advisory committees as a structural safeguard within the drug approval process.
Advisory committees serve a defined function within the FDA’s regulatory architecture. Composed of independent physicians, scientists, statisticians, and patient representatives, these panels convene publicly to evaluate evidence for investigational drugs, devices, and biologics, and to issue nonbinding recommendations to agency leadership. Their proceedings are open to the public, providing a forum in which drug developers, clinicians, and patients may address agency staff directly and on the record. The committees do not hold final decision-making authority, but their recommendations carry considerable weight and their public deliberations provide a layer of external review that many regulatory observers regard as essential.
The contraction in advisory committee activity has occurred against a backdrop of considerable institutional disruption at the FDA. The agency has experienced substantial staff turnover over the past year, and political leadership has assumed a more direct role in scientific determinations than has been customary in recent administrations. Commissioner Makary, who took office earlier this year, has publicly committed to what he has described as “radical transparency,” citing initiatives such as the public release of rejection letters as evidence of that orientation. Critics have noted, however, that reduced reliance on advisory committees cuts against that stated objective. The meetings represent one of the few mechanisms by which the FDA’s deliberative process is rendered visible to the medical community and the public.
The consequences of this shift extend beyond procedural concerns. Advisory committee meetings serve as a locus of scientific debate for contested or novel therapies, providing an opportunity for independent experts to scrutinize efficacy data, raise questions about study design, and articulate minority views that might otherwise remain outside the public record. When the FDA proceeds to approval or rejection without convening such panels, that layer of external deliberation is absent. For clinicians and researchers who rely on the transparency of the regulatory process to inform prescribing decisions and research priorities, the reduction in committee activity represents a meaningful narrowing of available information.
The FDA has not offered a comprehensive public explanation for the decline. The agency has discretion over when to convene advisory committees and is not required to do so for every drug application. Some FDA officials have suggested in the past that committees are most valuable for products with genuinely contested evidence bases or novel mechanisms, and that not every application warrants the expenditure of time and resources that a full public meeting entails. That position, while defensible in principle, does not by itself account for a 72% reduction in drug-related advisory activity within a single calendar year.
The pattern merits close attention from the medical community in Hawaii and nationally. Physicians and researchers who engage with the FDA’s regulatory outputs—whether as investigators in clinical trials, as authors of prescribing guidelines, or as participants in drug approval proceedings—have a professional interest in the integrity and openness of the agency’s review process. A sustained reduction in public deliberation, coinciding with elevated political involvement in scientific decisions and high institutional turnover, constitutes a combination of conditions that warrants scrutiny.
Biosimilar Development: Reduced Requirements, Anticipated Savings
On a separate regulatory front, the FDA has announced plans to ease certain development requirements for biosimilar medications, a move the agency estimates could reduce the cost of bringing a new biosimilar to market by approximately $20 million per product. The agency indicated it expects to issue draft guidance as soon as the week of March 9, 2026.
Biosimilars are biological medications developed to be highly similar to—though not identical copies of—existing brand-name biologic drugs, which are produced from living cells and tend to be substantially more complex in molecular structure than conventional small-molecule pharmaceuticals. Because of that complexity, biosimilar development requires a more elaborate demonstration of equivalence than generic drug development does. The FDA’s current regulatory framework requires sponsors to conduct a range of studies—analytical, nonclinical, and clinical—to establish that a proposed biosimilar has no clinically meaningful differences from its reference product in terms of safety, purity, and potency.
The planned guidance would reduce the requirement for certain of those studies, streamlining the development pathway without, according to the agency, compromising the scientific standard for approval. The FDA has not publicly specified which study requirements would be modified, though the draft guidance, once issued, will be open for comment from the medical and scientific communities.
The rationale for the policy is grounded in a longstanding observation about the U.S. biosimilar market: the United States lags considerably behind the European Union in the number of approved biosimilar products. The European Medicines Agency approved its first biosimilar in 2006, and the EU has since built a substantially larger biosimilar market relative to population than the United States has achieved. U.S. policymakers across multiple administrations have identified the development cost and regulatory complexity of the biosimilar pathway as contributing factors to that gap.
Biologic drugs are among the most expensive medications in clinical use. Products in categories such as monoclonal antibodies, colony-stimulating factors, and insulin analogs account for a disproportionate share of pharmaceutical spending in the United States. The introduction of biosimilar competition has the potential to reduce prices in those categories, as has been observed in European markets and, to a more modest degree, in the United States since the Biologics Price Competition and Innovation Act of 2009 established the domestic biosimilar approval pathway.
The proposed reduction in development requirements is part of what the FDA describes as a broader strategy to increase the competitiveness of the biosimilar market. If the estimated $20 million reduction in per-product development cost is realized at scale, and if it translates into increased market entry by biosimilar manufacturers, the downstream effect on drug pricing could be of consequence for patients, health systems, and payers. The magnitude of any such effect would depend on multiple factors beyond development costs, including patent litigation timelines, manufacturer pricing decisions, and pharmacy benefit structures—variables the FDA’s guidance cannot directly address.
For clinicians in Hawaii, where geographic isolation and a health system with distinctive demographic and payer characteristics create particular sensitivities to pharmaceutical pricing, the availability of biosimilar alternatives to high-cost biologics carries direct clinical relevance. Rheumatologists, oncologists, gastroenterologists, and other specialists who prescribe biologic therapies on a regular basis would benefit from an expanded range of approved biosimilar options, provided that the regulatory standard for demonstrating equivalence remains scientifically sound.
The tension between streamlining development pathways and preserving the rigor of equivalence standards is not trivial. Critics of biosimilar deregulation have consistently raised the concern that reducing clinical study requirements increases the risk that subtle differences in immunogenicity or efficacy between a biosimilar and its reference product may not be detected prior to approval. The FDA’s position is that advances in analytical characterization techniques have reduced the need for certain clinical studies that were required in earlier phases of biosimilar regulation, making the planned guidance a scientifically justified update rather than a lowering of the evidentiary bar. Whether that characterization withstands scrutiny will depend in part on the specifics of the draft guidance, which the medical community will have the opportunity to evaluate once it is published.
Two Signals, One Agency
The simultaneous emergence of these two regulatory developments—reduced advisory committee activity and eased biosimilar requirements—does not reflect a simple or coherent policy direction. One development raises concerns about transparency and external oversight; the other represents a specific, cost-motivated effort to expand market competition. Both, however, reflect the degree to which federal drug regulation remains in a period of active reconfiguration, with consequences for clinical practice, drug development, and public health that will unfold over the coming years.
The medical community’s role in this period is to engage directly with the regulatory process: submitting comments on draft guidance, participating in the public proceedings that remain available, and maintaining the analytical rigor necessary to evaluate regulatory claims on their scientific merits. The FDA’s decisions on biosimilar pathways and advisory committee utilization are not abstract policy questions. They bear directly on which treatments reach patients, at what cost, and on what evidentiary basis. That is a matter of clinical consequence, and it merits the sustained attention of physicians, researchers, and public health professionals alike.