What the Actual F?
Vinay Prasad, #2 at FDA, Gets Pushed Out
First, I apologize for my use (and implied use) of profanity. Swearing is my love language, so take it as a compliment.
What Happened?
Vinay Prasad, a top FDA official, resigned after fights with industry and harangues from right-wing activists. Prasad was the head of CBER, which regulates vaccines. He also was FDA’s chief medical and scientific officer, making him a top adviser to FDA Commissioner Marty Makary.
There’s speculation about why Prasad left, but some things are clear:
He alienated industry – Prasad tussled with Sarepta Therapeutics, which makes a gene therapy for Duchenne muscular dystrophy. FDA forced Sarepta to halt shipments of the treatment after patient deaths, but on Monday FDA reversed itself, allowing Sarepta to sell the treatment for some patients. It’s unclear if the reversal came over Prasad’s objection.
He alienated Trump – nobody works in this administration without passing a loyalty test and Prasad failed. The Wall Street Journal cast Prasad as “a Bernie Sanders Acolyte in MAHA Drag.” Plus, he got Loomered – the fate of anyone targeted by MAGA influencer (and Trump fan-girl) Laura Loomer. She called Prasad a “leftist saboteur” and said his regulatory philosophy was “fundamentally anti-Trump.” Over objections from Makary and HHS Secretary Kennedy, Trump ordered Prasad’s ouster.
A quick sidenote: HHS claims that Prasad left to spend more time with his family. No one on earth believes this. “Spending more time with family” is the first fake explanation in Getting Fired for Dummies.
What does this mean for MedTech firms?
More FDA chaos. The blowback probably won’t derail CDRH daily operations, but anything that requires Commissioner-level engagement will be slow and uncertain. This applies to novel technologies, regulatory shifts, new science, and congressional engagement. Bandwidth for this work will be depleted by time spent course-correcting CBER.
Fortunately, FDA has a secret weapon: George Tidmarsh (just kidding). Tidmarsh joined FDA as the new CDER (drug-center) director and he was immediately tapped as CBER’s acting director. For anyone keeping score, Tidmarsh comes to FDA with no prior government experience to head one of its most complex product centers. In his first week, Tidmarsh is told, “Congratulations, you’re now responsible for a second wildly complex product center.” Can he effectively run both centers? No way. Tidmarsh will keep the lights on at CDER and CBER, but real impact will wait until he sheds his second job. And that may take a while. CBER needs a permanent director, but what sane person would take that job when there’s no insulation from attack and they can be kicked out whenever the political winds change.
One more thing: Marty Makary doesn’t have the “juice” to help. He loved Prasad, telling Politico last week that “he’s an impeccable scientist. I think one of the greatest scientific minds of our generation.” Word has it that Makary was considering moving his FDA office to be closer to Prasad’s. They were also building pillow forts and having sleepovers (that last one’s a rumor I’m trying to start). Despite this favor, and the obvious harm to FDA, Makary hasn’t made a peep about Prasad’s ejection.
What should MedTech firms do?
Nothing (probably). Prasad’s ouster is nasty and likely bad for FDA, but this isn’t the hill for MedTech firms to die on. If CDRH runs business as usual, device firms can stay on the sidelines. Given the controversy and damage from Prasad’s ouster, that’s the wise move.
Still, MedTech firms must be extra vigilant. What happened to Prasad easily could happen to CDRH leaders. In that case, industry must oppose Trump’s “you’re fired” bent. No doubt, device firms and FDA will face problems going forward. But burning a house down because the toilet’s broken makes no sense. The right response is to fix the problem, and that happen best when FDA and industry collaborate.
Unfortunately, collaboration is now tricky. As I’ve written, HHS leadership appears to distrust industry, forcing device firms to work through proxies: “non-industry bodies that share industry’s priorities and objectives. . . . Proxies that support MAHA priorities are especially helpful because they’re less vulnerable to Kennedy criticism and derailing.”
Steve,
This piece holds up a mirror to the regulatory machinery and captures the bewilderment so many of us encounter when logic feels outpaced by its own design. Having served in leadership across industry and spoken in public–private arenas where science, policy, and public trust converge, I don’t see this as a regulatory failure, but a moment to reframe our approach. We need voices like yours, Steve: unflinching, deeply informed, and unafraid to surface uncomfortable truths. The goal isn’t just to decode dysfunction. It’s to redesign the dialogue and restore alignment between intention and impact.
Remember long ago, 1980s more or less CDER and CBER were one organization. The more things change, the more they stay the same? Next week’s history lesson will be on transitional devices once upon a time regulated as drugs.