One month into the new Trump administration, a whirlwind of executive orders and leadership appointments have slashed jobs, halted R&D funds and limited health agency communications.
Amid the changes, President Donald Trump signed an executive order establishing the Make America Health Again Commission, chaired by HHS Secretary Robert F. Kennedy Jr., to investigate and address the root causes of “America’s escalating health crisis.” The commission includes a number of high-level government officials and is directed to devise a strategy that combats chronic diseases, particularly those that impact children.
But within that broader framework is also language around ensuring “transparency,” restoring the “integrity of science” and “eliminating undue industry influence” in agency data. In particular, the order aims to eliminate “conflicts of interest” related to federally funded health research as one of four main policy directives.
The goals echo policy priorities Kennedy outlined in an op-ed last year.
And while the new executive order doesn’t mention advisory committees specifically, Kennedy expressed a similar plan to bring “radical transparency” to adcomms during his first speech as secretary earlier this month.
What could all these changes mean for the future of FDA adcomms and drug approvals?
The long road to adcomm reform
FDA advisory committees, which provide independent expert opinion on scientific, technical and policy issues and contribute to the decision-making process, already follow membership ethics guidelines. But their role has been scrutinized in the past.
Last year, the FDA was considering potential changes to the committees, such as eliminating their nonbinding voting process.
“Although advisory committees provide recommendations to FDA, FDA makes the final decisions,” the agency states in its adcomm guidance.
Former FDA commissioner Dr. Robert Califf believed adcomm votes create confusion about their role in the decision-making process and advocated for fewer committee votes.
While nonbinding, adcomms have still historically held sway over regulatory decisions, and the FDA has aligned its actions with committee votes about 88% of the time, according to a 2023 NIH study. The goal of strengthening standards for conflicts of interest has been floated for some time, but concerns have also been raised that new requirements could also make finding experts to sit on the committees a challenge.
“Overall, people do believe that it's best that committee members don't have conflicts,” said Jim Dibiasi, co-founder of 3D Communications, which works with biotechs and pharmas on FDA interactions and adcomm meetings. “Where it gets a little tricky is in the areas of orphan diseases, rare diseases, gene therapy, where the pool of experts is incredibly small. So then what do you do? Do you have an advisory committee without experts?”
The answer has been increasing transparency, with adcomm members contributing their expert opinion while also disclosing any pharma-related or financial ties and potentially abstaining from voting.
While it’s unclear what specific actions the MAHA commission could suggest to eliminate conflicts of interest among FDA adcomms, Kennedy’s speech suggests they could be in the line of fire.
The impact on drug approvals
Amid the speculation that changes are in store for adcomms, the FDA is already undergoing shifts. A communications freeze for HHS mandated by Trump led to delayed or canceled adcomm meetings in February because the agency interpreted the freeze to mean they cannot post notices to the Federal Register, as required for advance notice of meetings, DiBiasi said.
HHS has not communicated when the freeze will end and adcomm meetings will be rescheduled, if at all.
“There's a lot of anxiety and frustration over not knowing,” DiBiasi said.
However, adcomm meetings scheduled for later this year are still on, he noted.
“We have a couple of meetings scheduled in April. We've been told the meetings will go forward,” DiBiasi said, adding that he wasn’t sure of the status of March meetings.
A canceled adcomm meeting doesn’t necessarily impact a drug’s PDUFA date and the FDA could still approve new drugs on time.
But the widespread job cuts across health agencies by the Trump administration last week could hamper FDA work in general. Hundreds of jobs were slashed at the FDA, and the agency hasn’t stated if drug review offices were impacted.
With a diminished workforce, the approval process might ultimately include more adcomm meetings, according to DiBiasi.
“Staff reductions at FDA … and stricter conflict of interest rules could lead to more FDA advisory committee meetings if the administration wants more transparency and more public involvement,” he said.
If staffing for drug reviewers gets cut, it’s also possible the FDA wouldn’t be able to accept as many.
“Staff reductions will likely impact how FDA has to prioritize new applications,” he said.
That could mean drugs for larger populations take priority, while new medicines for orphan diseases or small patient populations take a back seat.
“On its face, that sounds like a really good way to prioritize. What are the consequences of that? You have hundreds of orphan diseases that all of a sudden aren't going to be looked at by the FDA, because they don't have the bandwidth to do it,” DiBiasi said.
