Who speaks at FDA drug hearings? Mostly supporters, study finds

When the FDA considers whether to approve a new drug, the public gets a say. Patients, doctors, advocates—anyone can show up to an advisory committee hearing and testify. The catch: the people who show up are overwhelmingly in favor of approval, and many of them have financial ties to the drug companies involved.

Researchers at Harvard Medical School and Brigham and Women's Hospital spent two years analyzing 161 FDA drug-approval hearings between 2015 and 2023. What they found raises a straightforward question: whose voice actually gets heard in this supposedly open process.

The Numbers Tell a Story

Patients and family members made up the largest group of speakers—48% of all testimony. That might sound right; people living with disease should have a voice. But here's where it gets complicated: 99% of patients and family members who had actually used the drugs recommended approval. Meanwhile, 72% of public health advocates—people representing broader community interests rather than personal experience—opposed approval.

The gap matters because it suggests a selection problem. If nearly every patient who speaks loves the drug, where are the people who tried it and thought the side effects weren't worth it. Where are the voices saying "this didn't work for me" or "the risks were too high."

Leah Rand, the study's lead author, put it plainly: "If 99 percent of patients who use the drug or their family members support approval, that raises the question whether there are people who had negative experiences who we're not hearing from."

Then there's the conflict-of-interest piece. Nearly half of all speakers—43%—disclosed some financial or professional tie to the drug company or its interests. And here's the kicker: people with conflicts of interest were 11% more likely to recommend approval than those without them. The FDA encourages disclosure but doesn't require it, which means the actual number of conflicted speakers is probably higher.

What This Means for Drug Approval

The FDA's advisory committees don't make the final decision on whether to approve a drug—that's the agency's call. But these public hearings are supposed to inform that decision. If the voices in the room are skewed toward approval and weighted toward people with financial stakes, the process starts with a tilt built in.

The researchers are now interviewing FDA advisory committee members and former agency employees to understand how much weight they actually give to patient testimony. They're also planning to convene experts to recommend ways to make the process more balanced—maybe finding ways to hear from people who had bad experiences, or making conflict-of-interest disclosure mandatory rather than optional.

It's the kind of unglamorous research that doesn't make headlines but shapes how medicines reach people. The question isn't whether patients should have a voice in drug approval—they absolutely should. The question is whether the current system is actually hearing from all patients, or just the ones most likely to say yes.