The Food and Drug Administration will aim to limit the participation of industry experts in the advisory committees that the agency consults for some regulatory decisions, Martin Makary, the FDA’s new commissioner, announced Thursday.
Advisory committees, which the FDA typically convenes for additional input on high-profile reviews or thorny clinical and regulatory issues, regularly include an industry representative alongside a dozen or so independent experts.
These representatives don’t vote on questions put to the committee. They are meant to share the perspective of their industry broadly, rather than of the specific company that employs them. There are also usually patient or consumer representatives on the panels.
Now, when not explicitly required by statute, the FDA will restrict industry representatives from taking part as a committee member.
“Industry employees are welcome to attend FDA advisory committee meetings, along with the rest of the American public, but having industry employees serve as official members of FDA advisory committee members represents a cozy relationship that is concerning to many Americans,” said Makary. “In fact, the FDA has a history of being influenced unduly by corporate interests.”
The FDA’s statement said its new policy won’t prevent company employees from attending or presenting their views at advisory committee meetings, and noted that exceptions could be made in “rare circumstances.”
While advisory committee meetings offer a public window into the FDA’s regulatory processes, their input is not binding. The FDA can go against their recommendations, although in practice the agency and its committees often align.
Generally, the FDA shapes advisory committee discussions by posing specific questions to the panel and guiding the conversation. If the committee is asked for input on a specific drug review, the developer of that drug will usually give an overview of its data, followed by presentations from an FDA review team that scrutinized those results. Committee members ask follow-up questions and then later vote.
As non-voting members, industry representatives don’t typically drive the conversation, although they share their thoughts alongside other panelists.
Makary announced the new policy alongside his first interview as FDA commissioner, conducted at the agency’s offices with former Fox News host Megyn Kelly and posted to the social media site X.
“I was shocked when I learned that employees of big pharma companies sit on FDA advisory committees as members,” Makary told Kelly. “We’re going to be replacing them whenever statutorily possible with patients and family caregivers.”
It’s not clear whether Makary would try to add an additional patient representative in the many instances where existing advisory committees already have one. It’s also unclear which advisory committees could be stripped of their industry representative.
The Food and Drug Administration Modernization Act of 1997 amended existing law to direct the Health and Human Services Secretary, or their delegate, to establish expert panels that include “a representative of interests of the drug manufacturing industry not directly affected by the matter to be brought before the panel.”
Makary has made common cause with his boss, HHS Secretary Robert F. Kennedy Jr., in targeting perceived industry influence over regulators like the FDA. A Johns Hopkins surgeon and author, Makary built a reputation as a contrarian, challenging medical consensus on several issues, including the need for children to receive COVID-19 boosters.
He was sworn in as FDA commissioner on April 1 and has kept a relatively low profile as Kennedy has ordered a drastic downsizing of the federal health workforce, including layoffs for several thousand FDA employees.
