By Bek Shackelford-Nwanganga, Kansas/Missouri Fellowship
In a 15-minute lightning talk, Suzanne Robotti discussed some of the surprising ways FDA Advisory Board committee meetings work and lifted the curtain on how committee members vote to approve or disapprove drugs.
Most committee members are researchers, professors, clinicians or pharmacists. In addition to medical professionals, every committee is required to have at least one consumer representative like Robotti, who has served on the FDA Advisory Committee on Drug Safety and Risk Management as a consumer representative since 2017.
“The consumer rep. is not supposed to be a medical person but instead is an advocate for patients, families and consumer interests,” she said. “The consumer rep is a generalist who is able to evaluate clinical trials but is not an expert on any one drug, issue or disease.”
The consumer representative is supposed to have relationships with consumer and patient-oriented advocacy groups but is not supposed to have any connections to pharmaceutical companies. Robotti said this rule is often broken indirectly, as many advocacy groups are funded by pharmaceutical companies.
“The FDA manages to ignore that way too often,” she said.
According to Robotti, the advisory meetings typically last one day. She said there are no public guidelines for when the FDA will call on an advisory committee, and about half the drugs they approve are OK’d without input from a committee.
“The assumption is that the FDA will call in an advisory committee when they’re not clear on the risk and safety profile,” Robotti said. “Or maybe they just want a committee vote to rely on.”
She noted that the meetings are open to the public and encouraged journalists to attend them. Here’s how they work:
In the morning at advisory committee meetings, the sponsoring pharmaceutical company presents two clinical trials. Next, the FDA discusses the clinical trials with the committee, explaining what they asked the drug company to do and how they responded. The FDA provides the committee with questions they’d like them to ask of the pharmaceutical company and tells the committee if they want them to vote to approve or disapprove the drug.
Between the morning and afternoon sessions, Robotti said there is public testimony about the drug being reviewed. Committee members are not allowed to ask if the person testifying has any financial ties to the drug company. Robotti said this is “insane.”
Robotti said there are other key questions committee members are not allowed to raise during these meetings. They are:
- How much the drug will cost
- If it will be covered by insurance
- If the drug will be available to those who need it
- What the risk is of off-label prescribing
There are 26 advisory committees in total, each comprising about seven to 20 members.
Bek Shackelford-Nwanganga is a health equity reporter for the Kansas News Service, an NPR collaboration. She was a 2024 AHCJ-Kansas-Missouri Health Journalism Fellow. Shackelford-Nwanganga is based in Kansas City.
