AdComms matter. They play an important role during the evaluation and approval of new treatments with impact across public health, public policy, engagement, participation, trust, media openness, governmental transparency, scientific discourse, and evidence-based medical decision-making. They also matter to a wide range of stakeholders and communities—patients, families, healthcare professionals, drug developers, researchers, regulators, public watchdogs, advocates, and activists [1,2].

Beyond providing transparency into the evaluation of benefits and risks of potential new treatments, they offer a unique opportunity to inform and contribute to FDA’s decision-making process.

FDA’s Stated Position on AdComms

AdComms serve multiple purposes. According to FDA’s website, they use AdComms to:

• Get advice from experts who work outside the agency.
• Work toward an open and transparent government.
• Encourage patients, healthcare providers, and other interested people to share their views during the open public hearing or by submitting comments to the open docket. [1]

FDA has emphasized the importance of public engagement and confidence in its decision-making:

The committees’ discussions are designed to help ensure that the public is clear about FDA’s expectations for data supporting safety and effectiveness, so that regulatory standards are well understood. This process is transparent, independent, and open to the public. Members of the public have the opportunity to address the committee and share their perspectives. [1]

FDA has also highlighted the role AdComms play in evaluating new therapies:

Part of the FDA mission is to evaluate new therapies and determine which are safe and effective for their intended use. This complex responsibility often involves many areas of expertise, and sometimes FDA turns to outside experts for counsel.

The primary role of the FDA Advisory Committee is to:

• Provide independent expert advice to the Agency in its evaluation of these regulated products.
• Help the agency move toward making sound decisions based upon reasonable application of sound scientific principles. [2]

Recent Trend toward Fewer AdComms

While FDA’s website indicates that AdComms bring value to their evaluation of new therapies and promote transparency and public participation, recent trends have been toward fewer AdComms. In 2025, there were fewer than half as many AdComms for drugs and biologics, and a lower percentage were focused on new products compared to prior years. As of publication, in 2026, both the number of meetings and the percentage focused on new products are lower still. In recent years, as well, FDA decisions have more often gone against Committee recommendations. [3, 4, 5, 6]

The Value of AdComms

The central value of an AdComm is the opportunity for the sponsor, the public, and stakeholder communities to contribute to FDA’s considerations and decisions. An AdComm can make the difference for the approval of a treatment, for who can receive it, and for the strength of its claims. Historically, there has been a striking correlation between the voting results of AdComms and subsequent FDA decisions. While the strength of the association was highest for positive votes, many of the approvals following negative votes have occurred after a substantial delay, suggesting that the sponsor may have been able to provide additional evidence to support approval. [7]

Having a standing committee and temporary members provide independent expert input, discussion, and voting can give FDA crucial support for difficult regulatory decisions. These meetings can increase the rigor of the regulatory science, elevating the entire decision-making process. The open public hearing and the public docket allow participation for patients, advocacy groups, family members, healthcare professionals, and other stakeholders. The meeting enables the public to see the government and the outside experts at work. This transparency can help stakeholders understand the data and have confidence in the ultimate decision. This confidence can arise from directly watching or participating in the meeting and through reporting from respected news outlets, other experts, advocacy groups, and a patient’s own care team. Beyond the live meeting, FDA’s website provides public access to the minutes, transcript, video, briefing documents, and slides from every AdComm. These materials are often the best and most complete representation of the efficacy and safety data that the public can readily access. [8, 9, 10, 11]

The Importance of AdComms for Rare Diseases

For rare diseases, AdComms may have particular importance. In these situations, external experts can provide important insight into the pathophysiology, the burden of symptoms and care, and the wider clinical context. Input from external experts, including FDA and sponsor invited speakers as well as temporary voting members, can provide important context for evaluating a treatment for a rare disease. The lived experience of patients and caregivers can also play a critical role because they are often best positioned to convey the disease burden and potential value of a new treatment. The open public hearing and the public docket provide important avenues for these and other stakeholders to contribute to the discussion.

Conclusions

AdComms matter. They contribute meaningfully to public health, public confidence, and regulatory decision-making. They enhance transparency, support scientific rigor, and create opportunities for stakeholder engagement in the evaluation of new therapies. They can take on even greater importance in the evaluation of treatments for rare diseases as well as in the first-in-class therapies and other novel therapeutic approaches.

To deliver on the full potential of an AdComm, it’s crucial to understand the perspectives and backgrounds of the Committee, to build content for clarity and impact. Being ready to handle questions effectively is essential to optimizing participation. Given the importance of effective engagement in this setting, developing and implementing an effective communication strategy is critical.

References

1. FDA. Advisory committees give FDA critical advice and the public a voice. Accessed May 5, 2026. https://www.fda.gov/consumers/consumer-updates/advisory-committees-give-fda-critical-advice-and-public-voice

2. FDA. Learn about FDA advisory committees. Accessed May 5, 2026. https://www.fda.gov/patients/learn-about-fda-advisory-committees

3. McKenzie H. FDA went against adcomm votes more, held fewer meetings in 2025. BioSpace. Published January 6, 2026. Accessed May 5, 2026. https://www.biospace.com/fda/fda-went-against-adcomm-votes-more-held-fewer-adcomms-in-2025

4. Ellis L. FDA increasingly diverged from advisory panel advice while holding fewer meetings in 2025. Patient Daily. Published January 6, 2026. Accessed May 5, 2026. https://patientdaily.com/stories/678233151-fda-increasingly-diverged-from-advisory-panel-advice-while-holding-fewer-meetings-in-2025

5. Lim D, Gardner L. The shrinking number of advisory committee meetings. POLITICO Prescription Pulse. Published August 8, 2025. Accessed May 5, 2026. https://www.politico.com/newsletters/prescription-pulse/2025/08/08/the-shrinking-number-of-advisory-committee-meetings-00499116

6. Lawrence L. As controversial decisions mount, FDA shuns public advisory meetings: Drugmakers and advocates want more insight into agency’s decision-making under Trump. STAT. Published March 9, 2026. Accessed May 5, 2026. https://www.statnews.com/2026/03/09/fda-cuts-back-advisory-meetings-controversial-decisions-grow/

7. Daval, C. J. R., Teng, T. W., Russo, M., Kesselheim, A. S. Association of advisory committee votes with US Food and Drug Administration decision-making on prescription drugs, 2010–2021. JAMA Health Forum. 2023;4(7):e231718. https://doi.org/10.1001/jamahealthforum.2023.1718

8. FAS. Improving public understanding of advisory committees. Accessed May 5, 2026. https://fas.org/publication/adcomm-public-awareness/

9. McCarthy K. Why advisory committees remain essential in an era of complex medicines. Pharmaceutical Executive. 2026;46(3).

10. Baden L. R., Solomon C.G., Greene M.F., D’Agostino R.B., Harrington D. The FDA and the importance of trust. N Engl J Med. 2020;383(27):e148. doi:10.1056/NEJMe2030687

11. Smith, J.F., Townsend, S.A., Singh, N., Ma P. FDA advisory committee meeting outcomes. Nat Rev Drug Discov. 2012;11(7):513–514. https://doi.org/10.1038/nrd3747