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FDA blindsided as Trump Admin cripples agency on its way out: It's “a full-frontal assault on public health," one official said.

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It's “a full-frontal assault on public health," one official said.

Last week, HHS said it had finalized a rule that would cause all FDA regulations to expire after 10 years unless they are reviewed. Critics of the rule, called Securing Updated and Necessary Statutory Evaluations Timely or “SUNSET,” noted that the FDA already has mechanisms to sunset outdated regulations, making automatic expiration dates unnecessary. But in a statement announcing the rule, HHS Secretary Alex Azar said that “finalizing our SUNSET rule will deliver for the American people better, smarter, less burdensome regulations in the years to come.”


Next, the HHS moved to permanently waive FDA’s review requirements of medical devices before they hit the market. Seven types of medical gloves have already been permanently exempted, and the HHS has proposed exempting 84 other medical devices, including ventilators, fetal heart monitors, infusion pumps, pediatric facemasks, and medical imaging equipment.


The HHS also moved to force the FDA to publish on its website the time it takes to review new drug applications, claiming that the agency’s current reviews are often too slow.


According to reporting by Politico on Tuesday, the FDA is now fighting to keep the HHS from stripping the agency of its oversight of genetically modified organisms—oversight that would instead be transferred to the US Department of Agriculture. The industry-backed plan to transfer oversight is reportedly being pushed by the White House.


In yet another strike, Politico reported Thursday that the Trump Administration is working to ram through term limits on top career scientists at the FDA, Centers for Disease Control and Prevention, and other health agencies. The regulation would mandate job reviews every five years, in which scientists would either be renewed or reassigned.


  • Guillotine 2
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Just now, CitizenVectron said:

Are these things that can be undone by Biden quickly?


Congressional Review Act might be able to move on some of it but someone still has to dig through and find things to use the CRA on. It's probably not day one stuff due to rules about how quickly you can flip enacted regulations. 

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Just now, BloodyHell said:

Nor does congress. Im sure its written on an arrow Pelosi is scared to shoot.

Honestly time in the Senate is the bigger issue. Between confirmations and the impeachment trial and the stimulus and the covid relief act, it's insane how busy they're actually going to have to be

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