More FDA drama: Top drug regulator calls it quits after 3 weeks

FDA's Drug Regulator Steps Down After Just Three Weeks Amid Turmoil and Rebellion Against Commissioner Makary's Plans.

Dr. Richard Pazdur, the newly appointed head of the FDA's Center for Drug Evaluation and Research, has decided to leave his position just three weeks after taking the role. His departure comes amidst a backdrop of controversy and rebellion against FDA Commissioner Marty Makary's plans to overhaul and expedite agency operations.

Pazdur, an oncologist who has worked at the FDA since 1999, was seen as a stabilizing force for the agency, which has been plagued by turmoil during the Trump administration. His appointment was viewed positively by agency insiders, industry representatives, and patient advocacy groups, but he quickly clashed with Makary over issues related to the legality and public health risks of his plans.

Pazdur expressed deep concerns about Makary's proposals, including a plan to reduce the number of studies needed for drug-related decisions and shorten review times. He also pushed back on Makary's plan to exclude agency career scientists from certain drug review processes deemed political priorities. These disagreements led Pazdur to consider retirement last month.

According to reports by Stat News and The Washington Post, Pazdur has now filed paperwork to retire at the end of this month. While he may still change his mind, a source told the Post that such a reversal is unlikely. Ellen Sigal, chairperson and founder of advocacy group Friends of Cancer Research, described Pazdur's departure as a "sad day for science and patients" and called him their "guiding light."

This is getting crazy like a real-life soap opera but instead of romances and scandals it's about the FDA . Three weeks in and out already? That's faster than I can down a whole pizza . Makary's plans are like that one aunt who just won't shut up – you know, annoying and making everyone want to scream . Pazdur was trying to keep it chill, but I guess some people just can't handle a little stability . Anyway, back to the soap opera – what's next? More drama or is it going to be a calm and quiet week?

This whole thing is wild, you know? I mean, someone new gets appointed to head up the FDA and they're already clashing with the commissioner over big plans to shake things up. It's like they didn't even do a proper background check or something . And now Dr. Pazdur is out, just three weeks in, and he was trying to be all reasonable about it too? I feel bad for him, but at the same time, I'm kinda glad he's getting out of there before things get any more chaotic .

It's also weird that everyone's making such a big deal about this. Like, we're in a pandemic and we should be focused on finding cures and stuff, not who's running the FDA . I mean, don't get me wrong, I'm all for transparency and accountability, but can't we just have a civil conversation instead of all this backstabbing? It's like, what even is the point of having a regulatory agency if you're just gonna let it descend into chaos .

And what about all the people who are left holding the bag? The patients who need access to new treatments and meds? They're going to be stuck in limbo while we figure out this whole mess . It's like, can't we just slow down for once and think this through before we make any more rash decisions?

I'm soooo disappointed ! Dr Pazdur was like the voice of reason at the FDA, especially after all the chaos during Trump's time . Makary's plans sound super sketchy and I totally get why Pazdur wasn't on board . It's sad that he couldn't make a difference before quitting . The patients and scientists are really gonna miss him ! Maybe Makary should listen to his concerns instead of ignoring them ? Anyway, I hope the FDA gets back on track soon!

omg what just happened? pazdur was like the voice of reason at the fda now he just upped and leaves after only 3 weeks in charge. i dont get why makary pushed him out over his concerns about the new plans. didnt they say they wanted a more efficient process? seems like a bad way to start it off Pazdur was always good with industry reps and patients, he had a rep for being fair. makary's got some serious work to do if hes gonna fix the fda

Ugh this is so frustrating!!! The FDA needs stability and consistency right now and Makary just goes ahead and tries to shake things up without thinking about the consequences . I mean, who does he think he is? Dr. Pazdur was clearly a voice of reason and now he's outta there . And what really gets me is that the people who are opposing Makary's plans are being silenced or pushed aside . The whole thing just feels like a power struggle to me . It's not about patient care or science, it's about politics . Anyway, can't believe I'm writing this post at 2am worrying about the future of our healthcare system

Man, can't believe what's going on with the FDA . One minute Dr Pazdur is all in to help out Commissioner Makary's plans, next he's stepping down . I mean, I get it, you don't wanna be part of something that's gonna hurt people or is just not right, but three weeks? That's like, a blink of an eye in government time . It's a shame, because I thought he was the one guy who could bring some stability to the agency .

And now it's all falling apart again . The commissioner's plans are just so... sketchy . Shorten review times? Reduce studies? That's not how you keep people safe . It's like they're gonna rush through all these new meds without even checking if they work or not .

Anyway, it's just a mess right now . I'm keeping an eye on it, but I don't know what the future holds . Maybe someone else will come along and sort things out .

This is a classic case of a regulator being held hostage by the politics . I mean, you've got a highly respected medical professional stepping down because he can't compromise on his values, and it's not just about the science anymore - it's about who's calling the shots around here . Makary's plan to speed up review times is great for profits but terrible for public health vs . It's like, are we prioritizing profits over people? That's a real question we need to be asking ourselves about our regulatory bodies .

And what's with the career scientists being excluded from certain processes? That's not just a power grab, that's a threat to the very integrity of the agency . It's like, if we can't trust our regulators, who can we trust? This is exactly why we need more transparency and accountability in our government .

Now, I know some people might say Pazdur was being too rigid or inflexible, but let's not forget he's a doctor with decades of experience . He knows what's at stake here, and his departure is a wake-up call for us all to pay attention to the people making these decisions . We need more voices like Pazdur in this discussion .

omg u guys can u believe this?! Dr Pazdur just left his job after only 3 weeks he was literally trying to do his job but the commissioner was being super stubborn about his plans and now the whole fda is all up in arms i feel so bad for dr pazdur tho, he's like a total hero for trying to speak up against the commissioner's plans especially when it comes to patient safety i mean what even is this plan with reducing studies and shortening review times? doesn't that just put people's lives at risk? anywayz i'm just hoping someone else steps in and does a better job than dr pazdur did fingers crossed!

oh no... just when we needed someone to stabilize the FDA, Dr Pazdur is leaving after just 3 weeks . It's like he got pulled back into the drama that Makary was trying to stir up . I can see why Ellen Sigal would call him her "guiding light" - he seemed like a calm and rational voice in all this chaos . But what's going on with Makary's plans? Are they really putting people's health at risk just to speed things up? The fact that Pazdur was the one who expressed those concerns makes me think there's more to this story than meets the eye . Whatever happens next, I hope it's for the good of patients and science .

omg like what just happened at the FDA?? i had no idea the head of the drug regulation center was leaving after only 3 weeks!!! Dr Pazdur seemed like a pretty cool guy too, been there since 1999 lol how long do people really stay in jobs these days? and now Makary's plans are causing all this drama... do you think he's trying to speed up some new meds or something?

I'm totally bummed out about this news . I mean, Dr. Pazdur was the perfect guy to bring some stability to the FDA after all the chaos during the Trump era . He's got tons of experience and knowledge in the oncology field and it seemed like he was gonna be a game changer for the agency . Now, because Commissioner Makary had his own plans and they didn't align with Pazdur's concerns about public health risks , Pazdur is outta there just three weeks in! It's like, what even is going on over at the FDA? Can we trust their decision-making process anymore? I hope he comes back to change his mind but if not, this is a huge loss for patients and science . Makary needs to get his priorities straight .

omg what's going on at the FDA like they just swapped one regulator for another and already they're having major drama it's crazy that someone would leave after 3 weeks, i mean i get it if you don't agree with someone's plans but to make such a big deal out of it...anyway Pazdur sounds like a good dude who actually cared about science and patients he should be commended for his efforts and not just up and leave

I feel bad for Dr Pazdur, he just wanted to do his job but couldn't make it work. It's like when you're trying to build a strong foundation on your personal projects but keep hitting roadblocks. Sometimes, even with the best intentions, things don't work out. This is a reminder that we gotta be realistic about our capabilities and not push ourselves too hard. Just because we have a vision doesn't mean it's gonna come true if it's not meant to be.

And it's also a sad day for science and patients, indeed! Dr Pazdur was seen as a stabilizing force, which is what we need in times of turmoil. It just goes to show that even the best of us can struggle sometimes. Let's take this as an opportunity to learn from each other's mistakes and keep moving forward with kindness and understanding towards one another

.. what's going on with Makary? I mean, I get it, he's trying to shake things up, but come on. Pazdur was like the calm in the storm during Trump's tenure, and now we're right back where we started. Expedite review times without proper oversight is a recipe for disaster . And let's be real, excluding career scientists from processes just because they don't align with politics is a huge red flag . I'm not surprised Pazdur pushed back hard - someone's gotta keep Makary in check .

And can we talk about how fast these plans are moving? Three weeks ago Pazdur's in the job and now he's out . What's happening to all those patients who rely on FDA approval? It's like they're being thrown under the bus . I hope someone's paying attention, 'cause this isn't just about Makary or Pazdur - it's about public health and science .

I'm still trying to wrap my head around why people are okay with shortcuts when it comes to drugs. Like, what if these new reviews are rushed and don't catch all the potential side effects? That could be disastrous . Anyway... I guess we'll just have to wait and see how this plays out .

Can't believe a guy who's been there since 1999 gets the boot just three weeks in. I guess even oncologists can't handle a commissioner's ego trip . Pazdur seemed like a straight shooter, but I guess he didn't want to be part of Makary's "expedite the approval and ignore public health" circus . It's sad that we're losing a voice of reason at the FDA when what we really need is more scrutiny on these new plans . Can't wait for the next head to roll... or in this case, just walk out the door .

I wonder what's going on behind the scenes at the FDA? It seems like they're really struggling to work with each other. Like, shouldn't they be on the same team, you know? The guy who left just started his job three weeks ago! That's crazy talk. And it's not like he was expecting any drama or anything. He even pushed back against the commissioner's plans because he thought they were too hasty? What's so bad about taking more time to make sure something is safe for public use? I'm kinda sad that he had to leave, but at the same time, I can understand why. It sounds like there was some pretty serious disagreement between them... Maybe they just need a fresh start or something?

I wonder if this is what happens when we put too much pressure on institutions to move fast? Like, I get it, timelines matter, but do we really need to rush into things without thinking them through? Pazdur was like the voice of reason in all this chaos, and now he's out. It feels like a lot of people were counting on him to hold the line against Makary's plans. But what does it say about our society when we're so divided that one guy can't even get his footing? I mean, I'm not saying Pazdur is perfect or anything... but isn't this just another example of how hard it is to find common ground and work together towards a common goal?

What's going on at the FDA?! First they got a new head, now he's out already... Like 3 weeks in and he's already over it? I mean I get it, not everyone can handle Makary's plans. But retirement after just 3 weeks? That's like quitting your job after a week and expecting everything to be cool again . Pazdur seems like a pretty level-headed guy, what was he thinking? Wasn't he supposed to be the calm in the storm or something? Guess not

I'm kinda surprised about Dr Pazdur stepping down so soon after joining the FDA. He seemed like a calming influence, especially given how rocky things have been during Makary's tenure . I get why he'd want to leave if he didn't see eye-to-eye with Commissioner Makary's plans, but it's a shame he can't make things work . The fact that patients and advocacy groups are mourning his departure is telling – the FDA needs stability right now . Maybe Makary will take some of Pazdur's concerns to heart?