New Study Shows How Positive Experiences and Conflicts of Interest Shape FDA Drug Advisory Meetings

A new analysis of U.S. Food and Drug Administration (FDA) Human Drug Advisory Committee meetings offers a detailed look at who speaks during these sessions and how their perspectives lean overwhelmingly toward supporting drug approvals. The findings come from researchers at Mass General Brigham, who examined a large dataset of meeting transcripts and minutes to understand who participates, what they say, and whether financial ties might be influencing the tone of public commentary.

Between 2015 and 2023, the team reviewed 161 FDA Human Drug Advisory Committee meetings and identified 1,481 testimonies delivered by 1,217 unique speakers. Public input is a required part of these meetings, and it turns out that 96% of them included at least one public speaker. These speakers generally fall into a handful of categories, and understanding that mix is key to understanding the tone of the conversations.

Across all testimonies, patients and family members accounted for the single largest group, making up 48% of all speakers. Many of these individuals had direct personal experience with the drug under review, often through clinical trials. The next largest group was clinicians, who represented 21% of testimonies. They were followed by public health advocates not aligned with disease-specific organizations (13%), and then patient advocates associated with specific conditions or advocacy groups (10%).

One of the most striking findings from the study is how overwhelmingly positive public testimony tends to be. Overall, 82% of all speakers supported approving the drug under discussion. Only a small portion opposed approval, and a minority were neutral. This support was especially pronounced among patients and family members: an extraordinary 99% of individuals in that category favored approval. This pattern suggests that people who come forward to speak publicly often do so because they have had positive, meaningful, or hopeful experiences with the drug.

However, the distribution of support wasn’t uniform across all speaker types. Public health advocates—specifically those not tied to disease-specific groups—were a notable exception. Among them, 72% of testimonies did not support drug approval. This difference may reflect the role these speakers play: while patient advocates often focus on individual benefit, broad public-health advocates may be more likely to highlight population-level safety, cost, or evidence-quality concerns.

The researchers also examined conflicts of interest (COI) and found that 43% of speakers disclosed some form of COI. These were typically financial relationships, such as personal or organizational funding from a drug manufacturer. It’s important to note that disclosure is not mandatory for public speakers at these meetings, which means the true number of COIs could be even higher. Speakers who reported COIs were 11% more likely to support drug approval than those who did not report one. This association doesn’t prove causation, but it raises reasonable questions about how financial ties may shape the dynamics of public testimony.

The goal of public input is to balance scientific review with the lived experiences of real people, making their voices genuinely valuable. But the authors of the study argue that the current system may unintentionally amplify highly positive experiences or perspectives connected to organizations with financial links to manufacturers. To address this imbalance, they recommend several improvements aimed at increasing transparency and broadening participation.

First, they propose mandatory COI disclosure for all public speakers. This would allow committees, policymakers, and the public to better understand the context behind each testimony. They also suggest that the FDA use independent sources—such as the Open Payments database for clinicians or publicly available organizational financial reports—to help verify potential conflicts.

Second, the researchers believe the FDA should actively pursue input from a more diverse range of stakeholders. This could include neutral clinicians, health economists, independent public-health experts, ethicists, and patient groups not connected to industry. Having a broader collection of viewpoints would provide a more complete window into the potential benefits and drawbacks of proposed treatments.

The study’s authors also highlight an important limitation: their work did not evaluate how much public comments actually influence the committee’s final recommendations or the FDA’s ultimate decisions. Advisory committees are not required to follow the majority sentiment of public speakers, and the FDA is not obligated to follow committee recommendations—though historically it often does. Still, the study helps illuminate the environment in which these discussions take place and the types of voices shaping the narrative around new drug approvals.

Because FDA advisory committees play a central role in reviewing evidence about new therapies, the transparency and balance of public input matter. These meetings are meant to elevate both science and personal experience—two perspectives that are equally real but sometimes in tension. Understanding how speakers are selected, who participates, and what motivates them is a valuable step toward strengthening the process.

To give readers helpful background, it’s worth briefly exploring how FDA advisory committees function. These committees consist of independent experts such as physicians, scientists, statisticians, pharmacologists, and patient representatives. They review data provided by drug sponsors and FDA scientists, weigh potential benefits and risks, discuss uncertainties, and ultimately vote on key questions such as whether the evidence supports approval.

Public testimony happens before committee deliberations begin. This format allows speakers to share real-world stories or concerns that formal trial data might not capture. For example, a patient may describe how a drug improved daily functioning in ways not measured by clinical endpoints. Conversely, a public-health advocate may point out gaps in data or safety concerns overlooked by anecdotal reports.

This structure reflects an ongoing challenge in medicine and regulatory science: while personal experience is deeply meaningful, it may not fully align with population-level evidence. Clinical trials aim to reduce bias and provide reliable data, whereas public testimony often reflects individual stories shaped by personal outcomes, hopes, or hardships.

Balancing these perspectives isn’t easy. When nearly all patient speakers support approval—and when a large portion have financial or organizational ties—the committee may receive a view of the drug that is disproportionately positive. That doesn’t make patients’ stories any less important, but it highlights the need for more systematic inclusion of voices who analyze data from different angles.

In addition to the study’s core findings, this discussion has broader implications for public trust in drug approval. The FDA operates under intense scrutiny, and any perception of imbalance—whether in scientific review, public testimony, or industry influence—can affect how people view new treatments. Strengthening COI transparency and diversifying participation could help reassure the public that decisions about new drugs are grounded in fairness, evidence, and integrity.

Overall, the study paints a clear picture: public testimony is a powerful part of FDA meetings, but the voices heard tend to lean strongly toward approval, especially when they come from individuals with direct positive experiences or potential conflicts of interest. The researchers’ recommendations focus on improving transparency and ensuring the advisory process reflects a more balanced mix of perspectives.

Research Paper:
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2841276