Few institutions wield as much influence over the trajectory of modern medicine as the U.S. Food and Drug Administration (FDA). Its regulatory decisions determine not only which treatments reach patients but also how quickly they become available and under what conditions they are used. The stakes are immense: every ruling reverberates through health systems, shapes the strategies of global pharmaceutical companies, and affects the lives of millions of people worldwide.
For decades, the agency’s advisory committee model has served as a cornerstone of this decision-making process. These committees, composed of outside experts, have operated with a degree of formality designed to foster transparency, scientific rigor, and public trust. Notices of meetings are published in advance, conflicts of interest are screened, discussions are documented, and recommendations are voted on in the open. Although this structure can be unwieldy and slow, it has historically provided legitimacy to FDA rulings by ensuring that complex scientific debates unfold under public scrutiny.
That longstanding balance is now being tested. Since assuming leadership, Commissioner Marty Makary has introduced the use of so-called “expert panels,” a mechanism intended to streamline deliberations on sensitive or urgent issues. Unlike the formal advisory committees, these panels are convened more informally, often with little public notice or record of deliberation. Supporters see them as a pragmatic response to the need for speed and efficiency in an increasingly complex therapeutic landscape, but critics warn that by sidestepping the safeguards of the traditional model, the agency risks undermining its own credibility, opening the door to selective evidence, and eroding public confidence in its regulatory integrity.
The FDA’s Traditional Advisory Model
The FDA’s advisory committees have historically functioned as formal, structured forums where complex scientific and clinical issues could be evaluated in public view. When a question of safety, efficacy, or labeling requires outside expertise, the agency convenes one of these committees, issuing a notice in the Federal Register and opening a public docket to solicit input. Meetings are scheduled well in advance, with detailed agendas and background materials made available to all stakeholders. Deliberations culminate in a vote, the results of which are documented and shared openly, providing a clear record of the evidence considered and the reasoning behind the outcome.
Safeguards have been built into every stage of this process. Members are screened for conflicts of interest to ensure that financial ties or other affiliations do not unduly influence recommendations. Committees are composed to reflect a balance of scientific disciplines and perspectives, drawing from academia, clinical practice, patient advocacy, and sometimes industry. Public participation is encouraged, often through open comment sessions, reinforcing the idea that regulatory science must be accountable to the communities it serves.
The most common — and fair — critique of this process has always been its slowness. Meetings can be lengthy, debates contentious, and the administrative burden significant. However, this measured pace has always been considered a valid trade-off for the legitimacy the process confers. By exposing scientific disagreements to public scrutiny and insisting on procedural rigor, advisory committees have helped sustain trust in an agency whose authority depends as much on perception of fairness as on technical expertise.
Enter the “Expert Panels”
Commissioner Makary has positioned the creation of new “expert panels,” ostensibly as a means to modernize FDA deliberations. The stated rationale is straightforward: advisory committees are often unwieldy, slow to convene, and heavily scrutinized for potential industry influence. By turning to smaller, more agile panels, the agency seeks to increase flexibility, move faster on urgent or controversial matters, and minimize the risk of capture by pharmaceutical interests. These panels are presented as a leaner, more pragmatic model for engaging external expertise in the context of therapeutic innovation outpacing traditional regulatory mechanisms.
In practice, however, the structure of these panels looks markedly different from that of the established advisory committees. They are typically scheduled ad hoc, assembled with fewer members, and not bound by the same statutory requirements that govern formal committees. They may operate without advance notice in the Federal Register, without open public dockets, and without recorded votes. Transparency is limited, with little assurance that deliberations are documented in a way that can later be scrutinized by stakeholders or the public.
Critics argue that this informality undermines the safeguards that give regulatory science its credibility. By avoiding the procedural checks built into advisory committees, expert panels create opportunities for selective inclusion of participants and evidence. Observers warn that the agency risks cherry-picking voices that align with predetermined outcomes while excluding dissenting perspectives. Without clear rules for membership, conflict-of-interest review, or documentation of proceedings, these panels may sidestep the accountability mechanisms designed to prevent regulatory capture in the first place, creating a rubber-stamp mechanism with only the appearance of rigor.
Transparency and Conflict-of-Interest Concerns
The shift toward expert panels has amplified concerns about transparency and conflicts of interest within the decision-making process under current leadership. Critics point out that the informality of these panels makes them especially vulnerable to being stacked with individuals whose perspectives may reflect fringe scientific views or whose professional affiliations create real or perceived conflicts. Without the rigorous screening processes that accompany formal advisory committees, the risk of biased recommendations increases significantly.
Transparency is also undermined by the lack of procedural safeguards. Traditional advisory committee meetings are announced publicly, with background materials posted in advance and full transcripts and voting records available afterward. By contrast, expert panels often operate with minimal notice, limited documentation of deliberations, and no formal voting structure. This absence of a public record makes it nearly impossible to assess how evidence was weighed, which voices carried influence, or why a particular conclusion was reached — critical elements that make regulatory decisions legitimate.
These challenges are compounded by internal capacity constraints at the agency itself. Recent staffing reductions have weakened the FDA’s ability to conduct thorough conflict-of-interest vetting, making it harder to identify and mitigate problematic relationships among panel participants. In the absence of sufficient oversight, even inadvertent conflicts may slip through, raising further doubts about the independence of recommendations.
By relaxing both procedural and internal safeguards at a time when resources are stretched thin, the FDA risks creating a perception that its new panels are not only less transparent but also more susceptible to undue influence — a perception that may be justified.
Case 1: SSRIs and Pregnancy
One of the most visible examples of the new panel approach has been the review of selective serotonin reuptake inhibitors (SSRIs) in pregnancy. The FDA convened an expert panel to weigh evidence on the safety of antidepressant use during pregnancy and its potential risks to the fetus. This is an especially sensitive area of regulation, as untreated depression can itself lead to serious health risks for both mother and child, while medication safety in pregnancy has historically been difficult to establish with certainty.
The panel’s deliberations raised alarm among many clinicians, including obstetricians and psychiatrists, who argued that the evidence had been selectively interpreted and presented without sufficient nuance. Critics noted that complex questions about dosage, timing of exposure, and patient-specific risk factors were largely flattened into broad recommendations that could discourage treatment even where the benefits might outweigh potential harms. Concerns were also voiced about the absence of diverse expert perspectives that might have ensured a more balanced discussion.
The implications of this panel extend beyond SSRIs themselves. By using an ad hoc structure to evaluate such a consequential issue, the FDA set a precedent for handling pregnancy-related drug safety questions without the rigorous transparency of advisory committees. Given the vulnerability of pregnant patients and the broader implications for maternal and child health, stakeholders warned that regulatory shortcuts in this domain could have lasting public health consequences.
Case 2: Menopausal Hormone Therapy
Another prominent early example of the new model was the FDA’s review of menopausal hormone therapy. The expert panel convened on this topic recommended updates to product labeling and called for expanded physician education on prescribing practices. The panel’s conclusions emphasized risks associated with long-term use, highlighting cardiovascular and oncological concerns, while encouraging clearer communication to patients about potential harms.
While the intent of providing greater clarity is difficult to dispute, the panel’s approach drew criticism for its lack of balance. Observers noted that the recommendations appeared overly simplistic, with limited attention paid to the nuances of individual risk–benefit profiles. For many women, short-term or carefully tailored hormone therapy remains an important tool for managing severe menopausal symptoms, and critics warned that the panel’s guidance risked stigmatizing its use in ways that might discourage physicians from offering appropriate treatment.
The scale of the issue magnifies these concerns. Millions of women in the United States rely on hormone therapy during menopause, and changes in labeling or prescribing culture could shift the standard of care almost overnight. By issuing guidance through a process that lacked the visibility and comprehensive vetting of a formal advisory committee, the FDA left itself vulnerable to charges that it was reshaping medical practice without the level of scrutiny typically sought for such a far-reaching decision.
Case 3: Talc and Other Controversies
The FDA’s use of expert panels has also extended to the contentious debate over the carcinogenic potential of talc-based products. Panels were convened to examine the scientific evidence on whether talc exposure poses risks of ovarian and other cancers. Unlike traditional advisory committees, these meetings unfolded without the established rigor of full transparency, public docketing, or voting procedures. For a topic that has already fueled decades of litigation and public anxiety, the absence of formal safeguards raised serious questions about whether the process could deliver a fair and credible assessment.
One of the most persistent critiques of the expert panel approach is its openness to perspectives considered to be from outliers or the fringe. By structuring panels more loosely, the FDA risks amplifying the voices of individuals whose views may not reflect the scientific consensus. In the talc case, observers warned that giving disproportionate weight to marginal opinions risks distorting public understanding and undermining confidence in the agency’s final stance.
The talc review also illustrates a broader pattern in how these panels are deployed. Rather than being used for routine regulatory decisions, they tend to emerge in areas that are politically charged, socially sensitive, or legally fraught — issues where the stakes are high and trust in the FDA’s objectivity is most critical. When panels are seen as shortcuts in precisely the situations that demand the greatest rigor, their use appears not only procedurally questionable but strategically unwise.
The Policy Dimension
The expert panels cannot be understood in isolation from broader policy shifts under Makary’s leadership. One of his signature reforms has been to limit the presence of industry employees on FDA advisory committees, a move intended to reduce the influence of corporate interests in regulatory decisions. Supporters framed this as a corrective to longstanding concerns about conflicts of interest and the perception that advisory committees were too often dominated by voices tied to the very companies whose products were under review.
However, the irony of this reform is that expert panels may introduce new types of bias and arbitrary influence. By forgoing established procedures for conflict-of-interest vetting, public notice, and balanced representation, the panels open space for selective participation that is harder to detect or challenge. Critics argue that in seeking to shield the agency from corporate sway, the FDA may have inadvertently created processes more vulnerable to other kinds of partiality, whether ideological, political, or tied to individual agendas.
There are also questions about legality. Federal statutes governing advisory committees, including the Federal Advisory Committee Act (FACA), establish clear requirements for public access, transparency, and record-keeping. Legal analysts have suggested that by convening expert panels outside of this framework, the FDA may be operating in a gray zone or even in direct violation of these statutes. If so, the panels not only risk undermining credibility but could also expose the agency to litigation and further political scrutiny.
Broader Implications for Science and Trust
The most significant consequence of the FDA’s reliance on expert panels may be further erosion of credibility. Regulatory authority depends not only on technical expertise but also on the perception that decisions are fair, transparent, and grounded in rigorous science. Once public trust is damaged, it is notoriously difficult to restore. For an agency whose rulings guide global practice, even the appearance of improvised or biased processes risks further undermining confidence.
The potential patient impact is particularly acute. If decisions are made without full transparency or sufficient scientific nuance, patients could face real harm, either through inappropriate discouragement of beneficial treatments or through inadequate warning about genuine risks. The stakes of flawed regulatory processes extend far beyond abstract debates about procedure; they can shape the lives of millions in tangible and lasting ways.
Industry stakeholders also have legitimate reasons for concern. Drug developers rely on the FDA to provide a consistent and predictable regulatory pathway. When processes appear ad hoc or outcomes unpredictable, it introduces uncertainty into development planning and investment decisions. An environment perceived as arbitrary or susceptible to outside influence complicates the already costly and risky task of bringing new therapies to market.
History offers sobering reminders of what happens when confidence in the FDA falters. Past crises, such as the fallout from the Vioxx litigation or ongoing debates over the agency’s handling of opioids, illustrate how lapses in perceived rigor and transparency can damage not only the FDA’s reputation but also public health outcomes. The new expert panels risk adding to this lineage of credibility crises at precisely the moment when regulatory trust is most needed.
Restoring confidence in the agency’s decision-making requires reaffirming the principles that have historically sustained its legitimacy: transparency, rigor, and accountability. Above all, the FDA should reinforce its formal advisory processes rather than weaken them. The traditional committees may be slower, but their structured safeguards provide the credibility that the agency cannot afford to compromise.
A hybrid approach could present an acceptable, pragmatic path forward. Expert panels might have value as supplementary forums, providing early input on emerging science, identifying knowledge gaps, or preparing issues for full advisory committee review. But they should not replace the formal structures that ensure balance, conflict screening, and a public record. Used in this way, panels could help improve efficiency without undermining trust.
Even more critical, there is an acute need to strengthen conflict-of-interest screening, even in the face of staffing constraints. The agency needs to devote sufficient resources to ensure that all participants in its deliberative processes are vetted for financial and ideological conflicts. This is particularly urgent in light of legitimate concerns that reduced oversight capacity has already left gaps in the system.
Transparency must also be non-negotiable. All deliberations — whether conducted through committees or panelsm— should be subject to public notice, accessible dockets, transcripts of discussions, and clear rationales for final decisions. Without these safeguards, even well-intentioned reforms will struggle to overcome skepticism.
Ultimately, rebuilding trust requires the FDA to demonstrate that it values evidence, diversity of input, and transparency over expediency. The credibility of the agency has been carefully built over decades but can be quickly eroded if shortcuts appear to substitute for science. By committing to processes that balance efficiency with rigor, the FDA can navigate the pressures of modern drug development while preserving the public trust that is foundational to its mission and its effectiveness.
Conclusion
The FDA’s embrace of expert panels allegedly reflects a desire to make its decision-making more nimble in the face of scientific and political pressures. However, the appealing promise of efficiency should not come at the expense of science, safety, and public confidence. By bypassing the safeguards that have long defined its advisory processes, the agency risks trading credibility for expediency. This tradeoff could ultimately weaken both public health outcomes and the FDA’s authority.
Efficiency has little value without rigor. Streamlined approaches can play a role, but only if they complement rather than replace the formal structures that provide transparency and accountability. Regulatory shortcuts may appear to solve immediate challenges, but they carry the potential to become credibility catastrophes. If the FDA is to sustain its central role in guiding global medicine, it must reaffirm that scientific integrity and public trust remain its highest priorities.
