Has the FDA ever swung so sharply along political lines in just one year? The U.S. agency has become a lightning rod for widespread partisanship, according to policy experts, who see a foundational shift with huge implications for the regulator’s future.
The current climate at the FDA is unprecedented in terms of the depth and breadth of its politicization, said Genevieve Kanter, economist and associate professor of public policy at the University of Southern California. While every presidential administration uses appointed positions to achieve ideological goals at the agency, the complete overhaul of staffing, expert panels and review processes has taken this level of control to a new degree, she said.
For example, the Commissioner’s National Priority Voucher pilot program revealed last year has raised concerns about not just who is making review decisions and based on what criteria, but the transparency with which health leaders will choose recipients. When Eli Lilly and Novo Nordisk said they planned to lower prices for obesity drugs, both companies received vouchers ahead of a presidential press conference on pricing, according to reports. The FDA has also had to delay two drug reviews that were part of the program due to safety and efficacy concerns.
"I worry about the quality of drugs that are going to be approved in the U.S., and I worry that more efforts are going to be aimed at lobbying or patronage as opposed to development. That’s a poor, inefficient use of resources."
Genevieve Kanter
Associate professor, public policy, USC
Using regulatory decisions as political currency could deeply impact the short- and long-term relevance of the FDA, Kanter said. Here, Kanter breaks down the major concerns after a year of increased agency politicization, the uncertainty it sows among drugmakers and patients, and what course corrections she believes would put the regulator on a better path.
This interview has been edited for brevity and style.
PHARMAVOICE: What short-term impacts at the FDA have been most concerning to you over the last year?
GENEVIEVE KANTER: What comes to mind immediately are the staffing cuts throughout the government and specifically at the FDA — both involuntary separations from DOGE, as well as the early retirements. That’s the first, most proximal effect on institutional expertise, which includes both how things get done and specific knowledge about drug products and research designs.
The second is politicization of the review process, and we see that with political appointments in positions that had previously been filled by career staffers. What we didn’t see in the first Trump administration but we’re seeing now is the politicization of product approvals and reviews, which is very problematic. That’s reflected in the Commissioner’s National Priority Voucher program, where we’ve seen voucher recipients who hadn’t even applied being chosen. It’s unclear what the standards are, except that they meet certain general criteria.
Third is the network of external expertise, where advisory committees are substituted with panels that don’t have to conform to guidance or regulations around conflict of interest.
This air of politicization goes both ways, and what we’re seeing now is, in part, a backlash to Biden administration priorities at the agency. Can you shed some light on how the current political swing stands apart from others?
I’m one of those people who saw politicization during the Biden administration as well, especially during parts of the COVID vaccine rollout and how they handled that. There is politicization just by virtue of the head of the agency and head of HHS being political appointees.
Where it’s different, when I look at it as an academic, is that we’re seeing a greater depth of political appointees, which leads to ideological biases. All administrations bring change and put their unique stamp on agencies to implement various priorities, but most FDA watchers are in agreement that this is to a far greater extent than we’ve seen in the recent past, including during the first Trump administration. These are the positions where you can have it both ways, appointing career staff with expertise. Certainly center directors are one of those.
From a historical perspective, is there a time when changes at the FDA were this ground shaking?
Nothing comes to mind. It’s unprecedented and too early to tell if appointments like [FDA Commissioner Dr.] Marty Makary or [CBER Director Dr.] Vinay Prasad are able to go from being iconoclastic outsiders to essentially effective bureaucrats, and I don’t know if they can. In one year, they’ve done the iconoclastic part and introduced so many changes, which is the MO of this particular administration, and we might only see the impact of that historically.
As a specific example, what concerns you about the voucher program?
I’m certainly not the only one troubled by the CNPV program. It promises reviews at a speed that we’ve never seen, and the staffing is not up to it. It’s hard to see how we can have the same criteria we’ve historically seen but in just one or two months. And then the arbitrary conditions associated with the vouchers aren’t about unmet need, but instead linked to factors like domestic production and promises of lower prices. Not knowing how recipients are chosen is problematic for setting a standard of approval. I’m surprised we haven’t seen litigation coming from this, but I think that’s the only thing that might be a reliable counterweight to these kinds of programs.
What are the course corrections that would make you feel more comfortable with the direction the FDA is heading?
The biggest would be hiring or rehiring staff. Low-quality decisions come from being short-staffed, especially when you’re up against PDUFA deadlines. And what I’d like to see is guidance that follows up after the press releases and the commentaries so people have something to work with. Greater certainty and better codification around programs, which I don’t think are all terrible. The release of complete response letters, for example, is overall a good thing. There’s something interesting also about the plausible mechanism pathway that was proposed. But we need to see the guidance and the criteria so that firms have greater certainty.
Longer term, what effects would you expect these changes will have for both the biopharma industry in the U.S. and its standing in the global arena?
This is a crucial moment that experts like [former FDA Commissioner Dr.] Scott Gottlieb have talked about. How much damage can these hiccups have in the next three years? It could put the U.S. behind as firms pause what they’re doing to see what happens. I worry about the quality of drugs that are going to be approved in the U.S., and I worry that more efforts are going to be aimed at lobbying or patronage as opposed to development. That’s a poor, inefficient use of resources.
What is at stake in terms of public trust in the FDA as an institution, and what would it take to build it back up?
Among the most impactful in terms of long-term impact — permanent impact, unfortunately — is damage to public trust. The damage that takes place in three or four years is so hard to get back, and it’s a big concern for me how political FDA decisions are becoming. What they can do is be very explicit about the criteria of these new plans, some of which are good ideas, like the rare disease pathway. And if patients start seeing expedited approvals for drugs that help the community, that can be a source of increased public trust, even amid instability and uncertainty.
