FDA Politicization Depth and Breadth ‘Unprecedented’: Professor
The current climate at FDA is unprecedented in terms of the depth and breadth of its politicization. That’s the view of University of Southern California economist and associate professor of public policy Genevieve Kanter in an online interview with PharmaVoice. She says that while all presidential administrations use appointed positions to achieve ideological goals at FDA, the complete overhaul of staffing, expert panels, and review processes in the current administration has taken the level of control to a new degree.
One of Kanter’s biggest issues is the new Commissioner’s National Priority Voucher pilot program. She said there are concerns not only about who is making decisions and based on what criteria, but also the lack of transparency in how voucher recipients are chosen. Using regulatory decisions as political currency could deeply affect the short- and long-term relevance of the agency, she said.
“It promises reviews at a speed that we’ve never seen, and the staffing is not up to it,” she explained. “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.”
Asked about short-term impacts that have concerned here the most, Kanter cited the staffing cuts that eliminated a lot of institutional expertise, both how things get done and specific knowledge about drug products and research designs.
She also pointed to the politicization of the review process, with political appointees now filling positions that previously were filled by career staffers. “That’s reflected in the Commissioner’s National Priority Voucher program,” she says, “where we’ve seen voucher recipients who haven’t even applied being chosen. It’s unclear what the standards are, except that they meet certain general criteria.”
Her third concern was the “network of external expertise,” with advisory committees being substituted with panels that don’t have to conform to guidance or regulations around conflict of interest.
Noting that she had seen politicization in the Biden administration, especially with how parts of the Covid vaccine rollout were handled, she said the difference now is the greater depth of political appointees, which can lead to ideological biases.
“All administrations bring change and put their unique stamp on agencies to implement various priorities,” Kanter says, “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.”
Kanter told PharmaVoice that the level of change at FDA is unprecedented, and it’s “too early to tell if appointments like [FDA commissioner] Marty Makary and [CBER director] 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.”
Asked what changes would make her feel more comfortable, Kanter said the biggest would be to rehire or hire staff. “Low-quality decisions come from being short-staffed, especially when you’re up against PDUFA deadlines,” she said. “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 gateway that was proposed. But we need to see the guidance and the criteria so that firms have greater certainty.”