FDA's top drug regulator, Richard Pazdur, Quits Just Three Weeks After Taking Job Amid Criticism and Tensions.
The Food and Drug Administration (FDA) has lost its lead agency for regulating prescription drugs just three weeks into the new role after an extremely tumultuous tenure. The decision of Richard Pazdur to leave his position comes amid a multitude of issues including allegations of petty revenge, public health risks, and accusations of erratic behavior by former officials.
Pazdur, who took over as head of the Center for Drug Evaluation and Research in late November, was seen as a stabilizing force during the chaotic Trump administration's final stretch. However, his tenure quickly turned sour after he expressed deep concerns about FDA Commissioner Marty Makary's plans to overhaul agency operations, citing significant public health risks.
According to multiple sources, Pazdur took issue with Makary's proposal to shorten the length of time spent reviewing labels for pharmaceuticals, which could have serious implications for patients. Additionally, Pazdur disputed the commissioner's decision to reduce the number of studies needed before making decisions related to medication labeling changes.
These disagreements between Pazdur and Makary were seen as a significant blow to the agency's credibility by industry representatives and patient advocacy groups. One prominent venture capital investor described the FDA as a "clown show" due to the instability caused by internal power struggles and controversy surrounding former officials.
Pazdur's abrupt decision to leave his position, reportedly filed with paperwork to retire in late December, has left many feeling sad for the loss of guidance from an agency insider who was well-respected by peers across the pharmaceutical industry. Ellen Sigal, chairperson of Friends of Cancer Research, expressed profound sadness at Pazdur's departure, calling him "our guiding light" and labeling his loss as "profound."
It remains to be seen how this sudden change will impact the FDA's operations and its ability to effectively regulate the pharmaceutical sector.
The Food and Drug Administration (FDA) has lost its lead agency for regulating prescription drugs just three weeks into the new role after an extremely tumultuous tenure. The decision of Richard Pazdur to leave his position comes amid a multitude of issues including allegations of petty revenge, public health risks, and accusations of erratic behavior by former officials.
Pazdur, who took over as head of the Center for Drug Evaluation and Research in late November, was seen as a stabilizing force during the chaotic Trump administration's final stretch. However, his tenure quickly turned sour after he expressed deep concerns about FDA Commissioner Marty Makary's plans to overhaul agency operations, citing significant public health risks.
According to multiple sources, Pazdur took issue with Makary's proposal to shorten the length of time spent reviewing labels for pharmaceuticals, which could have serious implications for patients. Additionally, Pazdur disputed the commissioner's decision to reduce the number of studies needed before making decisions related to medication labeling changes.
These disagreements between Pazdur and Makary were seen as a significant blow to the agency's credibility by industry representatives and patient advocacy groups. One prominent venture capital investor described the FDA as a "clown show" due to the instability caused by internal power struggles and controversy surrounding former officials.
Pazdur's abrupt decision to leave his position, reportedly filed with paperwork to retire in late December, has left many feeling sad for the loss of guidance from an agency insider who was well-respected by peers across the pharmaceutical industry. Ellen Sigal, chairperson of Friends of Cancer Research, expressed profound sadness at Pazdur's departure, calling him "our guiding light" and labeling his loss as "profound."
It remains to be seen how this sudden change will impact the FDA's operations and its ability to effectively regulate the pharmaceutical sector.
. This is like when you're trying to lead a team, and someone on the same team is trying to undermine your vision... what do you do? 
. It's not just about being the leader, but also taking responsibility for your own emotions and actions.
. Lesson learned: sometimes you gotta know when to fold 'em, and step aside before things get outta hand 
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It's like, you gotta wonder what went down behind closed doors. Was it really just about the labels or was there more to it? 
I'm kinda glad we won't have to deal with this drama anymore but at the same time, who's gonna fill his shoes now? 
but still kinda sad that they lost a reputable guy from within. hope whoever takes his place can keep things stable and focus on keeping meds safe for patients 
just heard that Richard Pazdur, the new head of the FDA's Center for Drug Evaluation and Research, is out after only 3 weeks in the job 
The whole thing just reeks of internal drama and power struggles. I don't get why Makary proposed those changes in the first place - is he trying to speed up the process or something? 
And seriously, who calls the FDA a "clown show"? That's just embarrassing for the industry. I guess we can expect some major disruptions now that Pazdur's out of the way... not good news for patients and pharmaceutical companies alike 
like what even happened? I feel bad for him, he was supposed to bring some stability after that crazy Trump era but it sounds like he got caught in a war between Makary and other officials 
anyway i guess this is gonna be a wild ride for the agency now... will they just sorta wing it or try to regroup? 
hopefully whoever steps in can do better than that clown show 
It's crazy how quickly things can go from bad to worse, especially when it comes to public health. The whole label review thing sounded super important... I'm guessing now the FDA will be in for a bumpy ride with these changes 
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... anyway, I guess that's what happens when you can't work together as a team 
...
now who's gonna step in & save the day? 
it's all about accountability, but is the fda really ready for that? 
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It's like they're playing a game of "who can mess with the pharmaceutical industry" and it's getting out of hand! I'm not saying Pazdur was perfect or anything, but this whole thing just stinks. I've got a feeling there's more to it than meets the eye... 
. Poor guy must've been driven mad by all the drama going on behind the scenes. It's a disaster for the FDA, if you ask me 
. Guess we'll just have to wait and see how things play out now 
. And now we're stuck without a lead agency and all this drama. The pharmaceutical industry's gonna have to wait and see how the FDA recovers from this 
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and now the FDA is left with a big void 
