- Dr. Martin Makary has barred pharmaceutical and regulated industry employees from serving as official voting members on FDA advisory committees to prevent corporate influence on scientific decisions.
- The move aligns with Makary’s promise to prioritize “radical transparency” and restore public trust by ensuring independent evaluations of new products, though industry representatives can still attend meetings as observers.
- The new rules expand roles for patients, caregivers and independent experts in advisory discussions, while limiting industry voting power unless legally mandated.
- The decision responds to years of accusations, including from HHS Secretary Robert F. Kennedy Jr., that the FDA acted as a “puppet” for Big Pharma, particularly regarding fast-tracked approvals and weak conflict-of-interest enforcement.
- Makary’s actions reflect his prior criticisms of FDA practices, such as bypassing advisory panels for COVID-19 boosters and blindly following WHO recommendations. His leadership aims to curb industry influence and uphold stricter ethical standards in regulatory reviews.
U.S. Food and Drug Administration (FDA) Commissioner Martin Makary has restricted employees of pharmaceutical companies and other regulated industries from serving as official voting members on the agency’s advisory committees.
In a post on social media platform X, formerly known as Twitter, Makary acknowledged the longstanding concerns about the perceived closeness of the FDA to the pharmaceutical industry. (Related: HHS and FDA launch groundbreaking chemical contaminants transparency tool.)
“While the FDA should be partnering with industry to ensure a user-friendly review process, the scientific evaluation of new products should be independent,” Makary said. “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 committees represents a cozy relationship that is concerning to many Americans.”
Under the new rules, which will be effective immediately, the FDA will strengthen the role of patients, caregivers and independent medical experts in advisory committee discussions. Industry representatives can still attend meetings and provide testimony, but they will no longer have voting or decision-making authority unless explicitly required by law.
“Public trust in the healthcare-industrial complex is at an all-time low. We need to restore impeccable integrity to the process and avoid potential conflicts of interest,” Makary said.
Makary is fulfilling his promise to curb Big Pharma influence and restore public trust
The decision follows years of criticism from public health advocates, including U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., who has accused the FDA of acting as a “puppet of Big Pharma and Big Food.” The agency has faced scrutiny over regulatory decisions perceived as overly favorable to industry, including fast-tracked drug approvals and lax conflict-of-interest enforcement.
During the confirmation hearing of Makary in March, he already raised concerns about conflicts of interest on FDA advisory panels.
Makary, a British-American surgeon and public health expert from Johns Hopkins University, is known for his work on reducing medical errors and his criticism of certain federal COVID-19 policies, including the dismissal of natural immunity and skepticism toward one-size-fits-all mandates.
In line with this, the Senate asked Makary for his insights about the sudden cancellation of a key FDA advisory committee (VRBPAC) meeting on updated flu vaccine strains. Makary denied involvement, but he criticized the U.S. system for often “rubber-stamping” World Health Organization (WHO) recommendations without independent scrutiny.
Back in 2022, Makary slammed the FDA for not convening VRBPAC before approving COVID-19 boosters, calling it “unconscionable.” He declined to commit to reinstating the canceled flu vaccine meeting but promised future advisory panels will operate under stricter independence standards. Makary also raised concerns about conflicts of interest on FDA advisory panels, echoing Kennedy’s calls for stricter ethics reviews.
“I want life sciences companies to thrive, but we need to call balls and strikes and to keep that independent scientific review process free of any conflicts,” Makary said at the time.
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