FDA's Top Drug Regulator Quits After Just Three Weeks Amid Tensions and Scandals.
In a shocking move, the top drug regulator at the Food and Drug Administration (FDA) has resigned just three weeks into his new role, citing irreconcilable differences with the agency's leadership. Richard Pazdur, an oncologist who had been working at the FDA since 1999, took over as head of the Center for Drug Evaluation and Research in November but quickly found himself at odds with FDA Commissioner Marty Makary.
Pazdur expressed deep concerns about Makary's plans to overhaul and expedite agency operations, including a proposal to reduce the number of studies needed to make drug-related decisions. He also pushed back on Makary's plan to shorten drug review times, citing concerns that it could be illegal and lack transparency.
The tensions between Pazdur and Makary led to Pazdur considering retirement just last month, according to sources close to the situation. However, he has since filed paperwork to retire at the end of the month, leaving the FDA without a clear successor.
Pazdur's departure is being hailed as a loss by patient advocacy groups, who had seen him as a stabilizing force in an agency that has been mired in turmoil during the second Trump administration. "This is a very sad day for science and for patients," said Ellen Sigal, chairperson and founder of Friends of Cancer Research. "Rick was our guiding light and this loss is profound."
The FDA's leadership crisis comes amid allegations of petty revenge against former business partners by previous agency officials. One venture capital investor had described the agency as a "clown show" due to its erratic and unpredictable operations.
As Pazdur departs, questions remain about who will lead the FDA's Center for Drug Evaluation and Research next. The situation has highlighted the need for greater stability and expertise at the top of the agency, which plays a critical role in regulating the $1 trillion pharmaceutical industry.
In a shocking move, the top drug regulator at the Food and Drug Administration (FDA) has resigned just three weeks into his new role, citing irreconcilable differences with the agency's leadership. Richard Pazdur, an oncologist who had been working at the FDA since 1999, took over as head of the Center for Drug Evaluation and Research in November but quickly found himself at odds with FDA Commissioner Marty Makary.
Pazdur expressed deep concerns about Makary's plans to overhaul and expedite agency operations, including a proposal to reduce the number of studies needed to make drug-related decisions. He also pushed back on Makary's plan to shorten drug review times, citing concerns that it could be illegal and lack transparency.
The tensions between Pazdur and Makary led to Pazdur considering retirement just last month, according to sources close to the situation. However, he has since filed paperwork to retire at the end of the month, leaving the FDA without a clear successor.
Pazdur's departure is being hailed as a loss by patient advocacy groups, who had seen him as a stabilizing force in an agency that has been mired in turmoil during the second Trump administration. "This is a very sad day for science and for patients," said Ellen Sigal, chairperson and founder of Friends of Cancer Research. "Rick was our guiding light and this loss is profound."
The FDA's leadership crisis comes amid allegations of petty revenge against former business partners by previous agency officials. One venture capital investor had described the agency as a "clown show" due to its erratic and unpredictable operations.
As Pazdur departs, questions remain about who will lead the FDA's Center for Drug Evaluation and Research next. The situation has highlighted the need for greater stability and expertise at the top of the agency, which plays a critical role in regulating the $1 trillion pharmaceutical industry.
This is so concerning. You'd think that having someone with 20+ years of experience would be enough to make them feel settled, but I guess not. 
A guy who's been working at the FDA since '99 just can't get along with the new commissioner? That doesn't seem like leadership to me... 
Not good.
And now we're paying the price because of it. 
Can you believe this? Pazdur quits after 3 weeks because he couldn't get along with Makary, but like, what did he expect? He's been working there since '99 and should've seen some changes coming 
. And honestly, $1 trillion pharmaceutical industry? That's some wild money 
. The FDA needs to get its act together ASAP, not just because of this leadership crisis, but also with all these scandals going on 
. Maybe it's time for a shake-up from the top? 
I don't know what's more concerning, the fact that Pazdur quit or the fact that the agency is so unstable that someone has to leave after just three weeks... it's like they can't even keep a top person for more than 3 months! 
What's going on over there? 
And why do patient advocacy groups sound so... sad? 
Like, is this really a big deal for them? 
This is a big deal! I mean, the head of the FDA just bails after 3 weeks because they can't agree on how to make decisions about new meds? It's like they're playing a game of musical chairs but instead of chairs, it's people's lives 
this is getting crazy 
seriously tho, can't believe Pazdur quit already! 
he's got a point about Makary's plans tho, we should be prioritizing patient safety over expediency 
FDA needs someone who's not going to compromise on those standards 
and honestly, it's sad to see him go 
hope whoever takes over can bring some stability back to the agency 
. Now what's gonna happen to the Center for Drug Evaluation and Research? 
. I'm also super worried about all the patients who are relying on the FDA to make sure their meds are safe. This is just another example of how broken the system can be 
. Can't we just have some stability and competence in charge for once? 
. It sounds like there were some pretty big issues with FDA operations that needed to be addressed. And it's not like Pazdur was a fan of rushing through things without proper testing... I mean, we don't want any more medicine disasters happening 
.
... like, how are we supposed to trust the FDA if they can't even get their own leadership straight 
. I guess only time will tell what's going on behind the scenes 
.
Anyway, hope whoever takes over next can bring some much-needed stability to the agency... and maybe even get rid of some of that toxic office politics 
how can they expect us to trust them when they can't even keep their own leadership stable? 
& honestly, I think the whole 'petty revenge' thing is just another layer of complexity 
The pharmaceutical industry is massive, like $1 trillion massive 
. Pazdur's situation was a perfect example of this... he was stuck in a toxic environment and couldn't shake off the negativity 
.
. It's a great reminder that being good at our jobs doesn't just mean we know what we're doing, but also means we can surround ourselves with talented and capable people who share our vision 
.