Most Speakers at FDA Advisory Committee Meetings Support Drug Approval

FRIDAY, Dec. 5, 2025 (HealthDay News) — Most speakers attending U.S. Food and Drug Administration (FDA) Human Drug Advisory Committee meetings about new drugs or indications support approval, according to a research letter published online Nov. 24 in JAMA Internal Medicine.

Leah Z. Rand, D.Phil., from Brigham and Women’s Hospital and Harvard Medical School in Boston, and colleagues analyzed nine years of meeting transcripts to identify speaker characteristics from U.S. FDA Human Drug Advisory Committee meetings from 2015 to 2023. Included meetings were those during which committees voted on new drug approvals or new indications for marketed products; of 161 meetings, 155 included public speakers.

The researchers found that there were 1,481 speaker testimonies given by 1,217 unique individuals: 48, 21, 13, and 10 percent were patients and family members, clinicians, public health advocates from organizations not representing specific diseases, and patient advocates, respectively. Forty-three percent of speakers disclosed conflict of interest (COI). Overall, 82, 11, and 7 percent of speakers supported drug approval, opposed approval, and were neutral, respectively. Except for public health advocates (72 percent opposed), more than 60 percent of each speaker type supported approval. Patients and family members with drug experience had the highest support for approval (99 percent), 12 percentage points higher than clinicians. Speakers disclosing COI were 11 percent more likely to recommend approval than those who did not.

“The voices of patients and advocates are vital, but to ensure more balanced input, the FDA should seek contributions from a broader range of perspectives and strengthen efforts to monitor and mitigate conflicts of interest among public participants,” Rand said in a statement.

Two authors disclosed ties to Alosa Health.

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