Forward to the past: The FDA commissioner dilemma
As we’ve all undoubtedly noticed, the FDA commissioner’s chair is conspicuously absent a duly deputized occupant, and a number of reasons have been offered to explain that. Some of these, such as the COVID-19 pandemic, will eventually give way, but some of the drag is unrelated to temporary issues, which is the more worrisome part of the problem.
As I wrote in 2019, the FDA commissioner’s post has been difficult to fill for more than two continuous years in recent history, with the six-year term of Peggy Hamburg serving as a statistical outlier. Steve Hahn, an oncologist by training and persuasion, was undercut by circumstances that are much more prominent than his bungled description of relative vs. absolute risk for the use of a drug therapy for COVID-19. One might plausibly assume, however, that burnout would ensue even if you remove that particular episode from Hahn’s time at the FDA.
The dicey ethics of a bioethicist
But here we are with an acting FDA commissioner more than half a year into this new administration, and the latest buzz is that Ezekiel Emanuel is gaining traction as the next FDA commissioner. I would remind the reader that Emanuel is the author of a proposition that medical care be rethought for those older than 75 years. I would also remind everyone that the current holder of the Oval Office celebrated his 75th birthday several years ago. But beyond that, what exactly is Emanuel’s portfolio? Oncology? Bioethics? If stinting on care for those aged 75 or older is his idea of ethics, my response is no thanks.
And yes, we’ve had oncologists in the FDA commissioner’s chair, such as Hahn and Andrew von Eschenbach, but Emanuel is best known for pushing various policy proposals related to health care delivery and payment. Whatever one thinks of these proposals, that’s not the FDA’s turf, any more than the cost of a drug or device is, and there’s enough mission creep going on at the agency as matters stand.
The problem with the status quo isn’t so much the question of day-to-day administration at the FDA as the question of expectations of the agency. Former commissioner Scott Gottlieb demonstrated a stunning mastery of relations with external audiences, including with the media, but that can’t be the standard going forward or we’ll all be sorely disappointed with the next half dozen commissioners.
The problem with the status quo is that an acting commissioner cannot be reasonably expected to have the respect and attention that is required of the job. This is true regardless of whether that acting commissioner possesses the kind of experience and understanding of the agency’s role that is needed for the job. Assuming this is all a decent characterization of the matter, we clearly need a fully empowered (pardon the expression) FDA commissioner, not an acting commissioner, however smart and capable that acting commissioner might be.
Frankly, it’s something of a stretch to imagine that the ongoing pandemic is a legitimate excuse for the Biden administration’s apparent inability to recruit qualified people. Yes, we’ll need more vaccines and diagnostics and so on, but the machinery needed for all that is already in place. Besides, the CDC has apparently anointed itself as the lead agency on pandemic-related policymaking, which is probably appropriate, given that the phrase “disease control” is part of its title.
What we need is a commissioner who “gets it” about the FDA, but we also keep hearing that nobody who gets it about the agency wants the job. Is that because of the sheer demands of the job? The way people on Capitol Hill and in the media treat the commissioner? The fact that you can make at least as much money in the private sector with half the headaches? I suspect they all have at least something to do with it, but maybe we should ask Amy Abernethy, who was at one time rumored to be on the White House’s short list, but who took a job in the private sector despite this glorious opportunity to run the FDA.
The dysfunction of post-mortems for the living
It’s difficult to avoid the conclusion that there’s a cost incurred in dissecting everything the FDA does like the corpse in a murder case, and treating every decision the agency makes as a portent of the end of times. There’s no need to highlight examples of the imbecilic rhetoric surrounding FDA approvals or lack thereof here, whatever one thinks of the Aduhelm controversy. The pressures of the job aren’t difficult to highlight, even if you’re not in the life science trade press or a member of industry. Even Jeff Shuren, director of the agency’s Center for Devices and Radiological Health, confessed that he sometimes felt like a piñata, and this was 10 years ago. Amplify that by an order of magnitude and you get a sense of what the FDA commissioner experiences week to week.
At the risk of coming across as a purveyor of gloom and doom, I have to say that this situation isn’t at all hopeful, especially when one considers the extent to which this is emblematic of our larger national dysfunction. At some point, though, we in the media, the Twitterverse, and on Capitol Hill might – and even patient groups at times – might want to look in the mirror and ask ourselves a simple question: If nobody wants the job, are we at least partly to blame?