
FDA Commissioner Marty Makary last week announced a directive that would limit industry participation in the agency’s advisory committees. But not only do company reps serve only as non-voting members, a 1997 law actually requires industry involvement.
Newly confirmed FDA commissioner Marty Makary wants to “restore impeccable integrity” to the drug review process, and he’s starting by banning pharmaceutical representatives from serving as members on some of the agency’s advisory committees. Reaction to this move, however, has been relatively muted.
“I don’t think [the new directive] will move the needle much,” Genevieve Kanter, an associate professor of public policy at the University of Southern California Price School of Public Policy, told BioSpace in an email. Kanter specifically noted that industry representatives are already non-voting members. “The central and perhaps more difficult conflict of interest issues relate to the industry ties of the scientific members of the committee, and that issue hasn’t been directly addressed yet,” Kanter said.
Steven Grossman, policy and regulatory consultant and author of the FDA Matters blog, concurred. “My advice to stakeholders: put your energies into proposals that make more of a difference than this one,” he told BioSpace in an email.
It’s unclear at this point how comprehensive the new policy will be. The new directive “limits individuals employed at companies regulated by the [FDA], such as pharmaceutical companies, from serving as official members on FDA advisory committees, where statutorily allowed,” according to the agency’s Friday announcement.
This reference to “statutorily allowed” could present a bit of a quagmire for the FDA. A provision in the Food and Drug Administration Modernization Act of 1997 “has been interpreted to mean that newly created advisory committees must include an industry representative,” Kanter said. “My guess is that the FDA may remove industry reps from advisory committees that existed prior to 1997.”
As of April 2024, the FDA had 33 advisory committees. The advisory panel, the Obstetrics and Gynecology Advisory Committee, was established in 1965, largely to track the safety of thalidomide. As of 1967, the Anti-Infective Agents Advisory Committee was also up and running. As of 1997, the Vaccines and Related Biological Products Advisory Committee and Oncologic Drugs Advisory Committee were also active.
But for advisory committees established after that 1997 legislation, it seems that industry representatives cannot, by law, be excluded.
Another interpretation is that the language only applies to advisory committees “regarding a clinical investigation or the approval for market for a drug,” Kanter said. Panels that review, for example, post-market safety or that discuss other regulatory issues, would not be required to have an industry rep.
Makary: ‘Surrounded by Swamp Creatures’
The question of potential industry influence on the FDA has been simmering for years, largely centered around the so-called “revolving door,” through which employees move from industry to FDA and vice versa. In an interview with former Fox News journalist Megyn Kelly last week, Makary referenced the case of Curtis Wright, the FDA examiner who signed off on Purdue’s infamous painkiller OxyContin and later left the agency to work for the now-defunct pharma.
“That’s the kind of thing that breeds distrust and that’s why people perceive that this agency, the FDA, has been captured by industry,” Makary told Kelly.
Newly appointed Health and Human Services Commissioner Robert F. Kennedy Jr. has taken this up, along with other potential “conflicts of interest,” he sees within the FDA. In a tour of the FDA campus earlier this month, Kennedy blasted the agency and its staff, accusing them of being a “sock puppet” to the pharma industry. After ousting Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research, the FDA appointed interim director Scott Steele, who has never worked at a biopharma company.
At another point during the interview, Makary said he was “surrounded by the swamp creatures” after his nomination for FDA commissioner.
“When I got his nomination for the job, I cannot tell you how many lobbyists, former members of Congress, the swamp, reached out to me,” offering to write letters on behalf of their companies to the senators on the confirmation committee. “You know what I said? Don’t talk to the senators. I don’t want your letters. They’re not for free. Those are obligations that then you feel indebted to return once you’re in office.”
The Advisory Committee Debate
Addressing the new policy directive regarding adcomms, Makary said, “The idea is that there should not be a cozy relationship. . . . There should be a user-friendly process for industry, but not a cozy relationship.”
For his part, Grossman offered points on both sides. “Industry representatives on advisory panels do not vote, do not have a professional or monetary interest in the outcome and have little ability to sway the outcome. Yet, they do provide a useful perspective that other panelists often value,” he said. “Nonetheless, the appearance is jarring and it is understandable that questions are being raised.”
Kanter added that industry reps “could present a practical perspective on the feasibility and implications of committee recommendations, as well as important constraints facing the sector—for example, issues with the supply chain or manufacturing.” The sponsor, who would also be in the meeting, “isn’t generally able to raise these concerns without being directly asked by committee members.”
As per Thursday’s announcement, Makary plans to replace the ousted industry representatives with input from patients, caregivers and other community representatives.
“Patient advocates and caregivers know a great deal about the health conditions that are affecting their daily lives, and some of them may be physicians or researchers themselves,” Kanter said. She acknowledged, however, that “in general, they do not go through the same screening process for scientific expertise as the other members and may not know as much about the scientific issues.”
Instead, these panel members play a different role in the conversation, “introducing information about the experience of living with the health condition or caring for someone with the condition, the needs, priorities, and sentiment of the patient community at large, and adding context and perhaps helping interpret the numbers and statistics,” Kanter continued.
Overall, she said, “This move is an important sign that Commissioner Makary will take a second look at the issue of industry influence on FDA activities, and I am generally supportive of that.”