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Maximum Chaos: Latest Top FDA Regulator Peaces Out After Only 3 Weeks

from the measuring-time-in-scaramuccis dept

In mid-November, we talked about yet more chaos occurring under RFK Jr., this time at the FDA. At issue was George Tidmarsh, who joined the FDA in July as the agency’s chief drug regulator. Tidmarsh had been accused of using his position to exact a vendetta campaign against a former business partner, Kevin Tang, and companies related to him. Tang had pushed Tidmarsh to resign from three companies years back and Tang recently sued Tidmarsh, claiming he’d dangled the approval of a drug ingredient over his head unless he made monetary payments to an organization associated with Tidmarsh for decades.

Tidmarsh resigned amidst the accusations, putting his tenure at the FDA at less than half a year. In his place came Richard Pazdur, an FDA veteran of over 25 years. His appointment was received well by many in the medical community, seen as a consummate professional stepping into the role. For example:

Cancer Nation applauds the choice of Dr. Richard Pazdur as the Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). We can think of no better person than Dr. Pazdur for this position, as he will bring scientific rigor, evidence-based regulatory review, and a commitment to patients to his work as CDER head.

“We are grateful that someone with both scientific rigor and lived compassion will be leading CDER, and we look forward to continuing our shared work to make sure every survivor gets the care they need to live well,” said Shelley Fuld Nasso, Cancer Nation CEO.

Unfortunately for all those feeling the warm fuzzies about Pazdur’s appointment, Padzur decided last week to retire entirely from the FDA. While he will serve in the role through December, his resignation comes a mere two-and-a-half Scaramucci’s after his appointment. (For the uninitiated, a Scaramucci is 11 days, termed due to the length of time Anthony Scaramucci served as White House Communications Director in Trump’s first administration.)

Why is Pazdur retiring so soon after his appointment to be the top drug regulator for the FDA? Simple: his professionalism is at complete odds with the Kennedy-appointed assclowns with whom he’d have to work.

Just days on the job, Pazdur expressed deep concerns about the legality and public health risks of FDA Commissioner Marty Makary’s plans to overhaul and expedite agency operations. On November 21, the Post reported that Pazdur disagreed with Makary’s plans to reduce the number of studies needed to make drug-related decisions, such as label changes. Pazdur was further concerned that Makary’s plan to shorten drug review times was not sufficiently transparent and could be illegal. Pazdur also pushed back on Makary’s plan to exclude agency career scientists from some drug review processes deemed political priorities.

The immediate tensions led Pazdur to first consider retirement last month, according to the Post’s sources. He has now filed paperwork to retire at the end of this month, according to Stat News, which was first to report his planned departure. The outlet noted that he could still change his mind as the retirement plan is not finalized. But a source for the Post said such a reversal is unlikely.

“This is a very sad day for science and for patients,” Ellen Sigal, chairperson and founder of advocacy group Friends of Cancer Research, told the Post. “Rick was our guiding light and this loss is profound.”

The retention of talent is typically a primary metric by which those in management are judged. And during Kennedy’s time at DHS, retention is best used as a word for delivering a punchline. Susan Monarez was also CDC Director for a mere three weeks, or two-and-a-half Scaramuccis, before being fired by Kennedy, reportedly over her refusal to rubber stamp Kennedy’s anti-vaxxer nonsense.

Whatever you think of RFK Jr., even if you’re a huge fan, this draining of talent over his management style and his anti-scientific bullshit is having a deleterious effect on American health. And that’s sort of the opposite of what a Secretary of HHS should be hoping to achieve.

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Comments on “Maximum Chaos: Latest Top FDA Regulator Peaces Out After Only 3 Weeks”

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3 Comments
This comment has been deemed insightful by the community.
That One Guy (profile) says:

Those who refuse to learn from history condemn others to repeat it

As the saying roughly goes ‘Safety regulations are written in blood’. As it turns out if the blood is dry enough people start to forget why they’re there and start thinking that they’re just in the way of progress(or more likely profits) and a new swath of people are condemned to suffer and die before it becomes clear yet again why those regulations were important and put into place the last time.

Anonymous Coward says:

Sad Irony

There’s a case to be made that the FDA’s process sometimes kills more people than it saves by delaying the approval of life-saving drugs. A recent partial vindication of is when Operation Warp Speed saved countless lives by ensuring people were vaccinated sooner than later by speeding up the approval process.

But the insufferable irony here is that this instance of truly life-saving deregulation is something today’s conservatives think was so damn terrible because they don’t understand basic epidemiology.

As for RFK, he seems to base almost all his thinking around putting the “naturalistic fallacy” into practice anywhere he can.

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