Dr. Marty Makary reported on the “early progress we’ve made working to remove all nine petroleum-based food dyes from the US food supply, and eliminating unnecessary animal testing requirements for drugs. We approved a new blood test for Alzheimer’s, which could help enable more early treatment.
Joke Inspections
“For the pharmaceutical manufacturing facilities overseas that the FDA inspects, there has been a routine of using scheduled inspections, which, in my opinion, are no inspections at all. They’re a joke, and we are moving towards surprise inspections. We don’t allow FDA inspectors anymore to accept limo rides from the pharmaceutical manufacturing companies that they are there to inspect. I’m amazed at some of the stuff that I’m learning when I look under the hood.”
Aside from the Foibles, Great Things Are Happening
“We’ve begun taking action against new challenges such as gas station heroin and childhood vaping with illegal Chinese vaping products. Our borders have been far too porous. Working with the Trump administration’s reenergized Customs and Border Protection. “We’re not wasting any time. Today, we are announcing the seizure of nearly two million illegal vaping products from China. Last week, we announced plans to withdraw from the market chewable ingestible fluoride tablets currently prescribed to six-month-old babies.
Regulating COVID Vaccine Boosters
“And this week, we published in the New England Journal of Medicine our framework for COVID vaccine booster regulation, so that developers and companies can see what we’re thinking and have predictability, and we are planning to bring back gold standard science and common sense.
“We also have to modernize on day one of me being on the job. I actively began an effort to organize to use AI for our scientific reviewers to make their jobs easier. Well, two weeks ago, we just announced our first AI Assisted Review with the latest generation AI technology. One reviewer said that what normally took him two to three days, the AI did in six minutes. I’ve set an aggressive goal of June 30 to have alI assisted scientific reviews. Help our reviewers agency wide. And we’re going to be ahead of schedule and under budget on meeting that aggressive goal. The goal is to reduce the paperwork burden of reviewers, which is tremendous, so that we can deliver more cures and meaningful treatments to the American people faster. That’s been the first seven weeks of my job at the FDA.
FDA Goals
“Here are other important goals I have for the FDA, and we’re already hard at work on them, healthier food for children, a universal flu shot, meaningful treatments for ALS Parkinson’s and other neurodegenerative disorders, treatments for rare diseases, cancer therapies that are so powerful a tumor is eliminated without the need for surgery or chemo. That’s not a theoretical that’s something we’ve already seen.
“And one of my highest priorities is to ensure that we are not wasting any time in evaluating novel treatments for PTSD. Many of our brave veterans served in unnecessary wars, and we owe it to them.
“I’ve not yet hit the two month mark, so I’m doing a lot of listening. I appreciate all of your input, but one question we must ask is, why does it take over 10 years for a new drug to come to market? My team and I are working very actively to examine the approval process in all of its details so we can try to figure out how to deliver more cures and meaningful treatments and devices faster and in a more user-friendly way for developers without cutting any corners on the scientific review and independence.
“We’re also committed to President Trump’s promise to lower drug prices at the FDA, we can help by bringing more low cost generics and biosimilars to market, among many other strategies we’re exploring.
“In conclusion, the FDA is filled with an enormously talented and committed group of employees representing in my opinion, one of the greatest brands in the world. It’s my duty to make sure that everybody’s central to the core mission has all the resources they need to do their job well.”
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