The US Food and Drug Administration (FDA) is in a state of turmoil after the sudden exit of its top drug regulator, George Tidmarsh. The agency's internal cracks and tensions have been exposed as officials scramble to find a replacement for the now-vacant position.
Tidmarsh's ouster comes after a series of upheavals at the FDA, including his own resignation in early November following accusations of retaliation against a former pharmaceutical business partner. Tidmarsh had also opposed a new form of rapid approval, which promised faster reviews of drugs but raised questions about its legality.
The agency is now facing a power struggle between Tidmarsh's successor, Richard Pazdur, and Vinay Prasad, the agency's chief medical and scientific officer. Prasad was forced to resign in July but returned unexpectedly just days later after reportedly being brought back by FDA chief Marty Makary.
This chaos has led to a degree of discord among top FDA officials that is "very unusual," according to Peter Lurie, president of the Center for Science in the Public Interest and a former associate commissioner at the FDA. The agency's careful processes for evaluating drugs, biologics, and medical devices are now under threat, and its credibility as an independent regulator may be undermined.
The pharmaceutical industry values stability at the FDA more than anything, and a core belief is that review processes should be predictable and reliable. However, with Tidmarsh's departure and Prasad's return, this predictability has been disrupted.
"It's like everything is up for grabs," Lurie said. "Suddenly, we have people who can get their drug reviewed in a one-day meeting." This could undermine the credibility of FDA experts and lead to concerns about the government's ability to be trusted.
The situation at the FDA is "difficult to overestimate" and leaves employees feeling disconcerted, Lurie added. The agency's appointments process has become an "enormous departure from accepted practices," and the use of a large number of applicants may give the impression that leaders struggled to find a suitable candidate.
However, Pazdur does have the right qualifications, and choosing an FDA insider might shore up confidence and morale. Nevertheless, the pharmaceutical industry and the public expect stability at the FDA, and any disruption to this is concerning.
Tidmarsh's ouster comes after a series of upheavals at the FDA, including his own resignation in early November following accusations of retaliation against a former pharmaceutical business partner. Tidmarsh had also opposed a new form of rapid approval, which promised faster reviews of drugs but raised questions about its legality.
The agency is now facing a power struggle between Tidmarsh's successor, Richard Pazdur, and Vinay Prasad, the agency's chief medical and scientific officer. Prasad was forced to resign in July but returned unexpectedly just days later after reportedly being brought back by FDA chief Marty Makary.
This chaos has led to a degree of discord among top FDA officials that is "very unusual," according to Peter Lurie, president of the Center for Science in the Public Interest and a former associate commissioner at the FDA. The agency's careful processes for evaluating drugs, biologics, and medical devices are now under threat, and its credibility as an independent regulator may be undermined.
The pharmaceutical industry values stability at the FDA more than anything, and a core belief is that review processes should be predictable and reliable. However, with Tidmarsh's departure and Prasad's return, this predictability has been disrupted.
"It's like everything is up for grabs," Lurie said. "Suddenly, we have people who can get their drug reviewed in a one-day meeting." This could undermine the credibility of FDA experts and lead to concerns about the government's ability to be trusted.
The situation at the FDA is "difficult to overestimate" and leaves employees feeling disconcerted, Lurie added. The agency's appointments process has become an "enormous departure from accepted practices," and the use of a large number of applicants may give the impression that leaders struggled to find a suitable candidate.
However, Pazdur does have the right qualifications, and choosing an FDA insider might shore up confidence and morale. Nevertheless, the pharmaceutical industry and the public expect stability at the FDA, and any disruption to this is concerning.
. The whole thing just feels so unsteady. First, Tidmarsh drops off the table and now there's all this power struggle between Pazdur and Prasad? It's like they're trying to outmaneuver each other. And let's be real, who wants their medicine reviewed in one day? 
That just doesn't sit right with me. I mean, what's the rush? The whole point of the FDA is to make sure these meds are safe and effective for us. If they can't even do that, then we should be worried.
I just hope they get their act together soon. The public needs stability when it comes to our meds and the FDA is supposed to be the one providing that. Without it, we're left feeling... uncertain 
.
!
, what's going on with the FDA?! 
They can't even keep one of their top regulators without freaking out... like a total power struggle 
! Richard Pazdur thinks he's got the right qualifications but come on, Vinay Prasad being brought back after getting fired is just shady 
. I mean, a one-day meeting for a drug review?! That's just crazy talk 
! The pharmaceutical industry needs stability and consistency, not this drama 
. Can't they just get their act together?! 
and maybe this is exactly what we need to revamp their processes and get that predictability back 
. plus, pazdur's got some solid qualifications, so i'm kinda hopeful about him 
... and let's be real, the pharma industry needs stability more than anyone 
. it's just a chance for them to regroup and come out even stronger 
I don't know what's more shocking, the fact that they're having these power struggles or that they can't even get a new person in without all this fuss 
My friend works in pharmaceuticals and she was like "omg what if this chaos affects our meds?!?" 
Pazdur seems cool tho, maybe he can bring some order to the chaos? 
! This power struggle between Pazdur & Prasad is getting OUT OF HAND 
. And now that Tidmarsh is gone, I'm really worried about the stability of drug approvals 
. One-day reviews? That sounds sketchy 
... it's like they're playing with fire over there. One minute George Tidmarsh is gone, the next Richard Pazdur comes in and then Vinay Prasad returns like nothing happened 
And let's not forget about the pharmaceutical industry - stability is key for them, so this whole situation has me spooked 
It seems like they're more worried about pleasing everyone than doing what's right. I just hope they get their act together soon because this is getting out of hand 
! Richard Pazdur vs Vinay Prasad - it's like two strong-willed characters from Westworld 
, and we're all just waiting to see who'll come out on top 
. The pharmaceutical industry is already freaking out about this, and I don't blame them 
. But seriously, what's going on with Marty Makary bringing Prasad back? Is that some kind of shady move? 
And Peter Lurie is just throwing shade on both sides 
... anyway, fingers crossed they figure it out and get back to making safe meds 
. Now it's just a matter of who'll be the next to get tossed out 
. The thing is, you gotta have some stability in those review processes or the whole system falls apart 
.
. The pharmaceutical industry is all about stability, fam 
and this drama is gonna hurt their rep big time 
.
but now it sounds like there are some major drama going down 
like who gets to make decisions and stuff? i guess it's kinda scary when ppl start making big changes in important things like medicine 
. We need some stability and predictability in the FDA, not this back-and-forth stuff 
and I'm thinking... shouldn't we be worried more about the state of our food industry than who's in charge of regulating meds? 
They just want stability too, you know? It's like, can't we just have a predictable system where meds get reviewed fairly and quickly? 
Without all the drama and backstabbing? 
. And if they're having so much trouble finding someone to lead them, maybe that's a sign that things need to change inside the agency 
.