FDA commissioner Alexander M. Schmidt

In all of FDA’s history, I am unable to find a single instance where a congressional committee investigated the failure of FDA to approve a new drug. But, the times when hearings have been held to criticize our approval of new drugs have been so frequent that we aren’t able to count them. … The message to FDA staff could not be clearer.

2013-11-26: as usual, the FDA is up to no good.

At the same time that the NSA is secretly and illegally obtaining information about Americans the FDA is making it illegal for Americans to obtain information about themselves.

2014-08-05: the FDA could help by eliminating its onerous rules for diseases with 60% mortality rates. Won’t happen of course, it’s easier to bury lots of innocents than to overcome cover-your-ass (pretty much the reason for the FDA to exist). Or as the onion put it, the Ebola Vaccine is at least 50 white people away.
2016-07-15: Fluoride still not available

American dentists first started using similar silver-based treatments in the early 1900s. The FDA is literally over 100 years behind the times.It seems that the future of dental treatment has been here all along but a combination of dentists wanting to be surgeons, lost knowledge, and FDA cost and delay prevented it from being distributed

Silver diamine fluoride been used for decades in Japan, but it’s been available in the United States, under the brand name Advantage Arrest, for just ~1 year. Toddlers in low-income families sometimes have to wait 1 year for fillings in an operating room. Transporting and treating frail patients, assuming they can afford to see a dentist, can be difficult. But now some patients can be quickly treated where they live.
2020-04-17: Nutrition overregulation

1 reason why food intended for restaurants is not reallocated to supermarkets: Nutrition labeling also frequently doesn’t comply with Agriculture Department and FDA guidelines for consumer sales

2020-12-05: This is nonsense. “Delay to allay” won’t convince anyone, and meanwhile people are dying.

Dr. Fauci said the politicization of the pandemic in his own country had led regulators to move a little more cautiously than the British, to avoid losing public support. There is no plausible reason why this basic analysis cannot be done in 24 hours. The FDA and external scientists have a simple task: confirm or reject the review already conducted by the trial’s independent data safety monitoring board before FDA submission.

2021-02-07: The FDA is unable to make sense.

Think of centers of expertise like the CDC or the IGM Economists Panel as giant systems for disentangling corruption and power. Their job is to produce 1 or 2 people who can get in front of the population and say something which has some resemblance to reality, even though the entire rest of the economy and body politic is trying to corrupt them. They…actually do sort of okay. Anthony Fauci is neither Attila the Hun nor Trofim Lysenko. He’s a kind of bumbling careerist with a decent understanding of epidemiology and a heart that’s more or less in the right place. The whole scientific-technocratic complex is a machine which takes Moloch as input and manages – after spending billions of $ and the careers of 1000s of hard-working public servants – to produce Anthony Fauci as output. This should be astonishing, and we are insufficiently grateful.

2021-02-15: Why isn’t there a reciprocal approval with the EU?

I’ve long argued that if a drug or medical device is approved in another country with a Stringent Regulatory Authority it ought to be approved in the United States. But, of course, the argument is even stronger in the other direction. Drugs and devices approved in the United States ought to be approved elsewhere. Indeed, this is how much of the world actually works because most countries do not have capability to evaluate drugs and devices the way the FDA or the EMA does. Although it’s the way the world works, few will admit it because that would violate pretensions of regulatory nationalism. Moreover, keeping up with pretenses means transaction costs and unnecessary delays. Regulatory nationalism has added months to vaccine delivery and now threatens to put to waste millions of stockpiled doses.

2021-03-02: millions of people die of heart disease every year. there has been no progress in artificial hearts in 50 years due to.. wait for it.. FDA:

The FDA gave Abiomed permission to implant 60 more devices, but it was clear that the heart would need to be updated, and then approved all over again—a lengthy process for which no one had the fortitude. “Abiomed threw in the towel. They were, like, ‘This is too hard!’ ”

2021-03-16: What are FDA inspectors even doing?

Grocery store workers are working, meat packers are working, hell bars and restaurants are open in many parts of the country but FDA inspectors aren’t inspecting. It boggles the mind.

Let’s review. The FDA prevented private firms from offering SARS-Cov2 tests in the crucial early weeks of the pandemic, delayed the approval of vaccines, took weeks to arrange meetings to approve vaccines even as 1000s died daily, failed to approve the AstraZeneca vaccine, failed to quickly approve rapid antigen tests, and failed to perform inspections necessary to keep pharmaceutical supply lines open.

2021-04-14: the FDA is completely insane and is halting the distribution for the J&J vaccine due to very rare side effects. as before, there’s no consequences for acts of omission vs acts of commission. they’re much more worried about their “reputation” than actually saving lives, just like ethicists have been in this crisis. a disgrace.

As the Johnson & Johnson vaccine pauses in the United States, Philip Bump for The Washington Post offers a quick visualization that shows 100 vaccinations per second. A red one appears if there’s a side effect. But because the side effect is rare, currently at 1 in 1.1M, the red dot on the visualization likely never appears as you watch. The blue dots are potential lives saved if the J&J vaccine continues.

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