Underground tunnels.
That is where the conversation began between Twitter/X CEO Elon Musk and former President Donald Trump before moving to reforming the US Food and Drug Administration.
Musk was discussing the impact of overregulation on drilling underground tunnels to alleviate traffic in congested cities when he deftly turned to another area that he believes needs reform.
“I think there’s room for some reform at the FDA for improving the speed at which we approve drugs that could help save lives and improve people’s lives,” Musk said during the 12 August interview.
“I worked very hard on that,” Trump responded.
Trump broadly claimed that drug review times were the lowest under his administration.
“You know we got that down to the lowest number ever and we got therapeutics approved in the FDA that people can’t believe the speed,” he said. “I took them on, I don’t think they like me too much, but I got things approved.”
Setting aside the argument over review times, the FDA could be a focus of disruption if Trump is elected to a second term in November.
An exodus of senior career FDA review managers is a potential regulatory risk for drug sponsors should Donald Trump win, according to a former high-level FDA official.
Any departure of key medical reviewers could thin out the ranks of already-overwhelmed drug divisions while simultaneously blunting enthusiasm for joining the FDA at a time when the agency is attempting to hire new people as part of the most recent user fee deal.
The potential trickle-down effect could range from a relative nuisance for understaffed drug divisions to an extreme of dysfunctional review teams, fewer sponsor meetings and missed deadlines.
Break The Mold Or Middle Of The Road?
Two key factors that could determine the level of disruption possible at the FDA in a second Trump Administration: whether the commissioner candidate is a deliberate, break-the-mold choice or more middle-of-the-road pick and the degree a Trump White House would view the COVID-19 experience as evidence of an FDA that is hostile to the administration and therefore in need of more hands-on attention.
Based on Trump’s interview with Musk, he would view the agency as hostile to a second administration.
Trump could be emboldened to select a radical candidate to lead the agency after consenting to more conventional commissioner choices in his first term.
Trump flirted with some decidedly unconventional choices to run FDA during his term, including Jim O’Neil, an advocate for “seasteading,” and Bilaji Srinivansan, a bitcoin entrepreneur, before eventually settling on a more conventional and experienced choice in Scott Gottlieb.
Gottlieb largely kept the FDA off Trump’s radar during his two-year tenure, and his successor, Stephen Hahn, also fit the conventional mold of a late-term caretaker leader for the agency, the Covid rollercoaster notwithstanding. (Also see “Gottlieb: FDA Would Be Subject To More White House Control Under A Second Trump Term” – Pink Sheet, 5 Feb, 2024.)
Senior agency officials underscored the sense of relief that Gottlieb was nominated and confirmed to run the agency in those first two years of the Trump Administration, with one calling him “a gift.”
Trump’s ability to name a permanent agency head who departs from the bipartisan consensus around the FDA would be limited in the unlikely scenario that Democrats retain control of the Senate. But a string of acting commissioners could be one workaround if Trump elects to go with a more libertarian, deliberately disruptive approach.
Peter Thiel was viewed as the primary Silicon Valley influencer and supporter of Trump during his first run for president and helped bring the earlier first-term commissioner candidates for Trump. However, Thiel has moved more to the sidelines in 2024, at least publicly. That could change at any time, however.
Trump still has prominent Silicon Valley backers who likely will play a role in recommending candidates for a second administration. Musk has formally endorsed Trump, although he endorsed Florida Gov. Ron DeSantis in the Republican primaries and said he voted for President Biden in 2020.
However, more substantial fundraising support is reportedly coming from venture capitalists Marc Andreesen, of Andreesen Horowitz/a16z, and David Sacks, of Craft Ventures.
Should Andreesen decide to lean into a theoretical second Trump term, he could have more influence in the health care space given the company’s significant investments in life sciences and health care. General Partner Vijay Pande leads a16z’s Bio+Health funds, which are invested in several therapeutics and artificial intelligence companies.
Earlier this year, Pande hosted a podcast with Joe Grogan, who worked in the Trump White House as Domestic Policy Council director and Office of Management and Budget-Health head, indicating at least a burgeoning connection between Silicon Valley and a former official likely to serve in a high-ranking role if Trump is elected.
A radical, or disruptive, FDA leader would not necessarily be a bad thing, according to one current senior agency official, who said the first step to a smoother transition is to be open to working with a second Trump Administration.
The official cited the Hahn’s term as an example of how the agency can work with appointees who do not bring deep familiarity or knowledge of the agency to the job.
The upcoming election is likely already having an impact on the FDA. CBER Director Peter Marks suggested during the Prevision Policy/Friends of Cancer Research Biopharma Congress in February that Presidential elections typically translate into a “slowdown” in hiring in April and May irrespective of politics because “people will start to be concerned about the fact that there is a chance of a change in administration” and hence “a change in policy.”
Marks described his comment as a “non-partisan observation” based on experience. (Also see “US FDA Gene Therapy Staff-Up: Glass Three-Quarters Full?” – Pink Sheet, 29 Feb, 2024.)
Marks himself could become something of a marker for how a second Trump term might play out at FDA. As the public face of vaccine safety and efficacy, Marks is already in the crosshairs for some in the Republican party. (See sidebar.)
The back-and-forth over the timing of the initial COVID-19 vaccine authorizations that occurred in 2020 could occasion some score settling in a second Trump administration. Bucking White House pressure, CBER had found a back door to publish guidance on expectations for EUAs that in effect set a timeline precluding availability prior to Election Day, which some Trump allies believe contributed to his defeat.
Finding Candidates
Former HHS Secretary Alex Azar said as a general rule for incoming Republican administrations, the President-elect will look to past administrations to fill key roles.
“There aren’t a lot of Republicans who do health care, and so it’s going to be the same people, just probably one level up from where they were in the first administration or in a Bush Administration,” Azar said during a 14 August webinar hosted by Avalere.
That may offer some clues as to where a second Trump transition could look to fill the role.
During an 11 August interview on Face The Nation with Margaret Brennan, VP candidate JD Vance was asked whether the abortifacient mifepristone would be a litmus test for a Trump nominee.
“For an FDA Commissioner that you would be part of choosing, where that Commissioner stands on this drug, would that determine whether or not they are chosen to be put in this key role?” Brennan asked.
“I think President Trump has clearly said there are no litmus tests on this particular issue,” Vance responded. “He just wants to make sure that drugs are safe and effective before they’re out there in the market, and, of course, that doctors are properly controlling this stuff so that people don’t get hurt.”
With the election around the corner, the FDA Commissioner search will start to emerge as a focus no matter the winner. Current Commissioner Robert Califf has said he would not serve in the current role beyond 2024.
Harris’ generally more progressive background could mean that she leans towards FDA commissioner candidates more aligned with the critique that the agency is too friendly to industry. (Also see “VP Harris ‘Marches In’ To Presidential Campaign: Will Policy Change?” – Pink Sheet, 1 Aug, 2024.)
But Trump’s choice could be anything but status quo.
