The Ledger
Every statement that passed quotation and attribution checks. Mix any filter with any other: certainty 1/5, debate potential 5/5, or both at once.
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Makary: FDA halted Biden-era policy allowing CAR-T cell editing in China
“We did find that there was in the Biden administration approval to have the cells of Americans for CAR T therapy shipped to China where the Chinese did the gene editing and then shipped back to the United States. To infuse in Americans. When I found out about …”
FDA Chief Makary: Ignoring COVID natural immunity was 'scientifically dishonest'
“Ignoring natural immunity, one of the most scientifically dishonest things a scientist could possibly say about the virus and the immunity.”
Makary: FDA reduces default drug approval requirement to one pivotal trial
“We announced just last month that we are going to go from a baseline default requirement of two pivotal trials for a drug to one pivotal trial for a drug.”
Makary: The Trump administration has not cut any NIH funding
“In the Trump administration, we have not cut one dollar of NIH funding.”
Makary claims 14% of all NIH grants went to DEI research
“14% of any NIH grants went to DEI research.”
Makary: Federal health officials released reduced core vaccine schedule of 38 doses
“So we gave them a list that constitutes about 38 doses from age zero to 18.”
Makary predicts GLP-1 drug starter pricing will drop to $149
“With the GLP-I example, for example, it's gonna come down to a 149 dollars for the first three months.”
Makary: FDA now makes all drug rejection letters public
“Our rejection letter is public, so that if the FDA does not approve a drug, the public deserves to know why.”
FDA removes nine artificial petroleum-based food dyes from U.S. market
“Within weeks of coming into office, we took action to remove all nine artificial petroleum-based dyes.”
Makary says he has approved 100% of Right to Try requests
“And I have signed 100% of Right to Try requests that come across my desk.”
FDA eliminates select regulatory requirements for cell and gene therapies
“And we announced just this week that we are getting rid of the, some of the regulatory requirements for cell and gene therapy.”
Makary: FDA created a plausible mechanism pathway for bespoke gene therapies
“These bespoke therapies, we created essentially a novel pathway for them. Dr. Vinay Prasad described it in the New England Journal of Medicine. It's called the plausible mechanism pathway, and it's basically combining gold standard science with common sense.”
Makary: 16-year peanut avoidance rule sparked modern peanut allergy epidemic
“Young kids should avoid peanut butter until they turn three. We got that wrong for 16 years. Tragically wrong. Igniting the modern day peanut allergy epidemic because peanut butter exposure in infancy reduces, there's something called immune tolerance, right? …”
Makary: Insulin resistance is at the root of almost every chronic disease
“And it is at the root of almost every chronic disease, insulin resistance, general body inflammation,”
Makary: 40% of American children have a chronic disease
“Well, first of all, we have failed with our food system. Look at the fact that 40% of American kids have a chronic disease.”
Makary: U.S. childhood vaccine schedule was an international outlier at 72 doses
“The United States vaccine schedule was an international outlier with 72 doses recommended between the ages of zero and 18.”
Makary: 60% of US antibiotic prescriptions are unnecessary
“60% of antibiotics prescribed in the United States Are unnecessary.”
Makary: FDA sent zero drug ad enforcement letters in previous year
“The Biden folks in the year before I came to the FDA sent out zero enforcement letters. A department of about 35 people in charge of sending out enforcement letters sent out zero enforcement letters.”
FDA issues 1,500 drug ad enforcement letters under Makary
“I sent out 1500 enforcement letters, including over a hundred cease and desist letters for ads that were creating a misleading impression, including online pharmacies that are advertising drugs without the same, ah side effects that pharma companies list when …”
Makary: FDA deregulating health wearables unless claiming medical-grade accuracy
“They're going to be deregulated, so you can give those results of any physiologic parameter, but if you say that it's a quote unquote medical grade blood pressure, then we are going to want to see the data to make sure that it's validated with the gold standar…”
Makary: U.S. food supply contains over 1,000 chemicals banned elsewhere
“So we have basically said we have a thousand chemicals plus in the U.S. Food supply that do, are not allowed in other food system supplies.”
Makary calls out Froot Loops for using petroleum dyes in U.S.
“Fruit Loops was making cereal for Canada, where the petroleum-based dyes were banned, and a different Fruit Loops for the United States for American kids.”
FDA initiates regulatory process to close GRAS food chemical loophole
“And so we've said, we have to close the loophole on grass. We started the regulatory process to do that.”
Makary: One in 12 boys in California is now diagnosed with autism
“One in 12 boys in California now being diagnosed with autism.”
Makary: Researchers suppressed 1960s Minnesota study showing low-fat diets increased heart attacks
“The Minnesota heart study was supposed to be the end all randomized trial in the 19 sixties. It showed the opposite of what they thought. The low fat diet group. This, these are 9000 Minnesotans randomized. Low fat group had more heart attacks, not less. They …”
FDA Commissioner Makary announces 42 major reforms in first 10 months
“We have announced 42 major reforms in my 10 months in office at the FDA.”
Makary: No FDA scientific reviewers were laid off during administrative cuts
“No scientific reviewer was laid off, but there were significant consolidations in HR, procurement, IT, and the duplicative services that were out there.”
FDA hiring 1,050 new scientists to expand accelerated drug approval pathways
“We are actually hiring 1050 new scientists because we have very ambitious goals on our new pathways, accelerated type pathways, and so we're building up capacity to have a whole new line of pathways so that we can deliver faster for the American people.”
Makary: FDA will use AI to cut application reviews to one day
“It took, and you know, some often still takes, 60 days just for the FDA to tell you that your application is complete. We're going to get that down to one day. We're going to use AI.”
Makary: 90% of drugs passing animal testing fail in human trials
“90% of drugs that pass animal studies do not pass safety and efficacy in humans.”
Makary: FDA granted 18 vouchers for rapid-approval pilot program
“We have, I think, 18 products that have vouchers for this new pilot program.”
FDA to allow Bayesian statistics in clinical trial evaluations
“Which we announced this week. We are now going to allow Bayesian statistics to be used.”
Makary: 38% of American children have prediabetes or diabetes
“38% of kids have prediabetes or diabetes.”
Makary: Refined carbs comprise 60% to 70% of American children's calories
“60 to 70% of the calories of a child in America today are refined carbohydrates.”
Makary: GLP-1 drugs reduce insulin resistance and systemic inflammation
“GLP-I's are mimicking a natural hormone in the body. And so when you get a supplementation of that, it's doing the job of increasing satiety, slowing down GI motility, and it has a profound impact on a number of conditions because you are also reducing insulin…”
Makary: One in six girls today will develop an autoimmune disease
“Where's the research on why one in six girls today will develop an autoimmune disease?”
Makary: Breast ultrasound detects 90% to 95% of lesions mammograms catch
“It picks up 90 to 95% of the lesions that a mammogram would pick up.”
FDA reduces biosimilar approval timeline from up to 8 years to 2.5
“We have changed the requirements so that we use the same principles we use for small molecules If you are structurally the same as a small molecule branded drug, we're going to approve you with some other stipulations. And so we are reducing the cost of R&D of…”
FDA changing regulations to close drug broadcast ad risk loophole
“We're closing that loop. We're changing the regulation to close that loop.”
Makary: FDA is customizing drug manufacturing requirements to specific patient populations
“The announcement that we made on Sunday was that we're going to customize the manufacturing requirements to the drug and the population being treated.”
Makary: Average two-year-old has received over 2.5 antibiotic courses
“The average two-year-old has already received over 2.5 courses of antibiotics.”