Weeks into his tenure, FDA Commissioner Dr. Marty Makary addresses turbulence described by current and former officials, asserts his independence, and holds hopes for a better agency.
After reading this (and your piece yesterday), I still see no reason to have any hope in Makary making things better at the FDA.
The NYT article that you referenced states "In fact, scientists had been fired from several food and drug safety labs across the country, including in Puerto Rico, and from the veterinary division where bird flu safety work was underway." So he flat out lied.
Also, his claim that there will be no reorganization is unbelieveable. You cannot fire 3,500 people and expect the agency to run efficiently. Support staff is essential.
The NYT article quotes Dr. Robert Califf, the F.D.A. commissioner under President Joseph R. Biden, said the terms “decapitated and eviscerated” seemed fitting to describe the steep loss of expertise at the agency. “Most of it is really at this level of fundamental, day-to-day work that has a huge impact overall, but it’s not very controversial,” he said. “It’s just that it takes work, and they have to have people to do the work.”
Regarding Novavax: Does its EUA have an expiration date? With the current level of population immunity, it may take a tremendously large study to demonstrate efficacy. This may not be feasible, and I’m sure that Makary knows this. This is particularly worrisome when several states are considering banning mRNA vaccines — if Novavax is no longer available, where does that leave us?
I suspect that Dr. Makary will find out, like all of those who have signed on thinking maybe they can make a difference from inside, that his reputation and character will have been permanently damaged. Unlike some few holdovers in Trump 1 (such as Dr. Fauci), he will have no real impact on the overall destruction of our medical and public health establishment - just look at the tap-dancing he had to do with RFKJr looking over his shoulder. The climb is not just uphill, it's Sisyphean.
After reading this (and your piece yesterday), I still see no reason to have any hope in Makary making things better at the FDA.
The NYT article that you referenced states "In fact, scientists had been fired from several food and drug safety labs across the country, including in Puerto Rico, and from the veterinary division where bird flu safety work was underway." So he flat out lied.
Also, his claim that there will be no reorganization is unbelieveable. You cannot fire 3,500 people and expect the agency to run efficiently. Support staff is essential.
The NYT article quotes Dr. Robert Califf, the F.D.A. commissioner under President Joseph R. Biden, said the terms “decapitated and eviscerated” seemed fitting to describe the steep loss of expertise at the agency. “Most of it is really at this level of fundamental, day-to-day work that has a huge impact overall, but it’s not very controversial,” he said. “It’s just that it takes work, and they have to have people to do the work.”
Regarding Novavax: Does its EUA have an expiration date? With the current level of population immunity, it may take a tremendously large study to demonstrate efficacy. This may not be feasible, and I’m sure that Makary knows this. This is particularly worrisome when several states are considering banning mRNA vaccines — if Novavax is no longer available, where does that leave us?
I suspect that Dr. Makary will find out, like all of those who have signed on thinking maybe they can make a difference from inside, that his reputation and character will have been permanently damaged. Unlike some few holdovers in Trump 1 (such as Dr. Fauci), he will have no real impact on the overall destruction of our medical and public health establishment - just look at the tap-dancing he had to do with RFKJr looking over his shoulder. The climb is not just uphill, it's Sisyphean.
STAT news has added your interview to their reporting on the possibility that Covid vaccines will not be available in the fall--Novavax not approved and clinical trials vs strain rule applied that would make new boosters unavailable: https://www.statnews.com/2025/04/30/rfk-jr-vaccine-policy-hhs-changes-mrna-vaccines-novavax-delays-pediatric-covid-shots/
And you're cited on CBS:
https://www.cbsnews.com/news/fda-covid-booster-shots-marty-makary/
So sad!