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13:05:39 MARTIN MAKARY, FDA
Now, with that 2002 Women’s Health Initiative study, suggested that there was an association with breast cancer.
Doctors called their panel of patients to tell them to get off of it immediately. The many benefits of hormone therapy were ignored, as it was seen as a carcinogen.
Prescriptions for hormone replacement therapy plummeted in the United States. Women flushed their pills down the toilet.
The amazing thing was that there was no– in that 2002 paper, there was no statistically significant increase in breast cancer mortality. Amazing.
But as a result of the fear of breast cancer, 50 million-plus women have not been offered the incredible potential tealth benefits of hormone replacement therapy, because of medical dogma.
One of those women was my mother, who went through perimenopause around that time. She went on to have a couple bone fractures subsequent to that in the course of her older life.
So I was struck when I learned that hormone replacement therapy, started within 10 years of the onset of menopause, reduces the risk of bone fractures by up to 50%.
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13:08:20 MARTIN MAKARY, FDA
Today, we are interested in learning, and that is why Dr. Brenner and myself have convened incredible experts on this topic, well-published, with impeccable credentials, to separate medical dogma from evidence.
So, I look forward to learning from all of you. I would be very interested in your thoughts on what we discovered when we came to the FDA a few months ago.
Number one, there is a black box warning on vaginal estrogen, even though the North American Menopause Society and the American College of Obstetrics and Gynecology has called for removing it.
We discovered that there is a black box warning on systemic estrogen, even though no clinical trial has ever found an association between hormone replacement therapy and an increase in breast cancer mortality.
So we want to learn from all of you. Update us. Teach us about the latest evidence. And help guide us as we think through what should be done here at the FDA.
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13:12:16 HEATHER HIRSCH
I am a women’s health, fellowship-trained, board-certified internist.
And on behalf of the entire menopause expert panel, I would like to say we are honored and excited to be here for this life-changing conversation.
Our purpose here is clear, to provide concise and logical information in support of the safety of menopausal hormone therapy.
I completed 2 years of advanced women’s health training at the Cleveland Clinic, and during my training, I pored over the research only to find something earth-shattering, that history got it wrong when it comes to menopausal hormone therapy.
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13:14:58 HEATHER HIRSCH
A boxed warning, formerly known as a black box warning, is the highest safety-related warning that can be placed on a medication by the FDA.
By definition, this means that the medication can incur serious and or life-threatening adverse events. This makes patients and clinicians afraid of these medications, and it may be extraordinarily unnecessary, as we’ll see from the evidence today.
With my 2 minutes remaining, I want to make 3 clear and concise points.
Number one, vaginal or local estrogen is categorically safe for all women. Period. Because it does not travel systemically, there, again, are no increased risks of heart attacks, clots, or strokes. And the black box warning is wrong, and should be removed.
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13:17:45 BARBARA LEVY
I want to share with you my sense of doom in July of 2002. I have PTSD from that day, when the NIH press conference occurred.
I can tell you where I was. I can tell you what I was drinking, which was…. Soda water. Um, I was on my way back to Seattle, where I practiced from an ACOG committee meeting.
And I can tell you the devastation of the patients in my practice.The phone calls, the just overwhelming upheaval of everything that happened over the next 20-plus years now.
It has been a huge harm for women.
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13:28:35 JOANN PINKERTON
The boxed warning is not supported by science. It harms women.
It reflects an estrogen class labeling, which was extrapolated from the systemic hormone therapy trial that I just showed you, average age 63. It overstates risk.
There is an absence of randomized clinical trial or consistent observational evidence linking vaginal estrogen to GSM, to cancer, heart disease, dementia, blood clots, or stroke.
And if you look at blood levels for systemic hormone therapy, they are dramatically higher than the levels we see with these local vaginal estrogens, dosed to treat GSM.
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13:30:49 JOANN PINKERTON
So, I am begging the FDA, and all of us are begging, please remove the boxed label. Put a warning, if you bleed, you need to be evaluated for that rare risk of endometrial cancer. If you’ve had an estrogen-sensitive cancer, please include your oncologist.
And please stop harming women.
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14:11:41 RACHEL RUBIN
Here’s the secret. Local vaginal hormones, estrogen and DHEA, are not only similar to, but actually way better than Viagra.
Because not only do they help with sex and urinary symptoms, they prevent urinary tract infections. Big time.
This guideline-supported fact says that we can prevent more than 50% of people’s urinary tract infections with local vaginal hormones. And we have known this for decades. So why haven’t you heard of this before?
Because your doctor doesn’t know this either. And because my friends, women’s health has a marketing problem.
UTIs, by the way, don’t just mess with the quality of your life, they kill the people you love. A lot of people. And it costs us taxpayers a lot of money.
UTIs cost 7 million hospital visits a year, and make up 25% of infections in older adults. Mortality from UTIs is rising, and we all know that chronic antibiotic use is extremely dangerous.
A 2024 publication by our sexual medicine research team showed that if women in Medicare used vaginal estrogen, which the cash price can be as low as $13 a tube, we could save our government billions of dollars per year in reduced UTI costs.
This is why my colleagues and I have spent the last 7 years advocating for the American Neurological Association clinical guidelines on GSM, endorsed across multiple specialties, these guidelines clearly state that local vaginal hormones are safe, effective and essential.
And yet, FDA, your box label that was blanketly placed on all products in 2003, has no data to support its existence when it comes to these local vaginal hormones. And it scares patients and clinicians daily.
Surely, 22 years later, and consensus guidelines later, this deserves another look. There is not a single study in the literature that says local vaginal estrogen causes stroke, blood clots, heart attacks, breast cancer, or probable dementia, which is what your box says. Not a single study.
But FDA, I’m actually here for a personal reason. Honestly, your label tried to kill my mother.
She was in the ICU for 6 months. While in a coma, immunocompromised, and with a catheter, the team refused to start her home dose of local vaginal estrogen. They had never heard of it before. Let alone in the ICU setting.
They justified their answer, their no, by saying the box says stroke, heart attacks and blood clots. I rolled up my sleeves, and I showed them the data, and insisted.
CDC is poised to build on recent progress in reducing overdose deaths and remains committed to supporting the Overdose Data to Action (OD2A) program. OD2A directly aligns with administration priorities by advancing data-driven strategies to prevent overdoses and save lives.
Secretary Kennedy has made a leadership change within the Immediate Office of the Secretary. Effective immediately, Matt Buckham will serve as Acting Chief of Staff.
Mr. Buckham currently serves as the Secretary’s White House Liaison at the U.S. Department of Health and Human Services, where he oversees the recruitment and onboarding of political appointees across the agency. He brings valuable experience in personnel strategy and organizational management to this new role.
Secretary Kennedy thanks the outgoing leadership for their service and looks forward to working closely with Mr. Buckham as the Department continues advancing its mission to Make America Healthy Again.
14:19:48 KENNEDY: I’m particularly happy to be here today because this is relevant to my favorite food, which is ice cream.
Since we’ve– since we came in about five and a half months ago and started talking about eliminating dyes and other bad chemicals from our food, we’ve had this extraordinary response from the industry, from – and Brooke just rattled off this inventory, this extraordinary inventory of national corporate food producers who have all made commitments to remove food dyes from their food.
And with this addition today of the dairymen and the dairy food producers, we now have about 35% of American food industry that has made commitments.
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14:21:53 KENNEDY: I grew up in a world where milk was the healthiest thing that you could eat.
There’s been an attack on whole milk and cheese and yogurt over the past couple of decades.
And Brooke and I, our agencies, are about to release new dietary guidelines in the next several months that will elevate those products to where they ought to be in terms of contributing to the health of our children.
There’s a tremendous amount of emerging science that talks about the need for more protein in our diet. And more fats in our diet.
And there’s no industry that does that better than this industry.
I’m very grateful for this industry for stepping up. Not only on this, but over the past 10 years, they’ve removed 60% of the sugar from milk products in school lunches. They’ve pledged to continue to reduce the amount of sugar in the food.
But this step is an extraordinary step, and I’m very proud to be part of this partnership. I’m very, very grateful to the industry.
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14:32:17 ANDY JACOBS, IDFA: And you may ask, why are we taking this action today? There are 3 good reasons.
First, many of the commercial ice cream manufacturers have already phased out certified artificial colors. And many others are currently working with suppliers to phase them out as quickly as possible.
Second, by taking this step now, ice cream manufacturers are ensuring that ice cream remains a special part of our lives. As consumer preferences change and the nation’s regulatory priorities evolve, as ice cream makers, we want to ensure families continue to enjoy their favorite wholesome ice cream treat.
And third, this is about showing consumers and our communities that we are stepping up.
We know that Americans eat roughly 19 pounds of ice cream a year. Think about that. We also know that ice cream is important to our dairy farmers, our ice cream-making communities and our food retail partners.
U.S. Ice cream contributes almost $12 billion to the U.S. Economy. And supports over 27,000 dairy industry jobs. We want to ensure that we continue these bonds with our consumers.
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14:37:57 KENNEDY: There’s a international measles outbreak right now. We are doing probably better than any– certainly better than any of the other industrialized countries in the world in controlling it.
We’ve had about 1,300 measles cases in this country. In Mexico, just as one example, there’s over 3,000, and they have one-third of our population. There’s about 3,000 in Canada, and they have one-eighth of our population.
In Britain, or in Europe, there are, I think, over 12,000 cases, and so we’ve done a very, very good job at controlling it. We have all the places where there’s outbreaks, the outbreaks are actually declining.
We have CDC teams everywhere where governors have requested it, and we are also taking care of those populations that don’t want to vaccinate. Most of the cases are unvaccinated Americans. There’s some populations that do not want to vaccinate. We’re making sure that their protocols for treating people who actually get measles.
So, if in the individual states, if there are issues, we are there for them.
But I– we don’t at this point consider it a national emergency.
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14:42:19 MARTIN MAKARY, FDA: Look, since Ansel Keyes in the 1960s decided to demonize saturated fat with a hypothesis that was supported with data that was incomplete and methodologically flawed in his seven-country study, the medical establishment started with a robust debate in the New England Journal of Medicine, among academics of the National Academy.
But that debate ended in the 1970s, because there was groupthink. The medical establishment locked arms and walked off a cliff together, insisting that the reason for heart disease in the United States was that people were not eating skim milk and no fat and low-fat foods, ignoring the roles of refined carbohydrates and so many other things that drive general body inflammation, which is the precursor of fat deposition in the arteries.
Well, that dogma still lives large, and it– you see remnants of it in the food guidelines that we are now revising. So we’re going to ensure that the new guidelines are based on science and not medical dogma.
Marty Makary, FDA [00:01:09]
Well, first of all, there’s a thousand chemicals in the U.S. food supply that are not in the food supply of Europe. And so we’re doing an inventory of all of them and these petroleum based food dyes, that is artificial food dyes, have been implicated in attention deficit disorder and other problems in the health of children.
So we’re saying we want to see natural ingredients. We want to see people eat less ultra processed foods. The dyes make these ultra processed foods more attractive to young children.
And so we’ve approved now natural dyes from natural ingredients. We’re going to approve another one on Monday, this coming week. And we want to see a move away from these petroleum based eyes.
We saw already the maker of Skittles announced they’re gonna get rid of titanium dioxide, another chemical that we’d like to see out of candy. And so we’re going to keep going like this.
You know, I don’t believe our childhood diabetes epidemic is a willpower problem. We’ve got to look at what we are doing to children.
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Marty Makary, FDA [00:05:56]
So on Monday here, we’re going to announce a new natural dye that is from natural ingredients. I can’t say what it is now, but we’ve been doing this every few weeks and we’re going to keep going. We want to see people use whole ingredients.
People ask me, what do I need to do to be healthier? And I’d say some basic simple things: drink water instead of these sugary drinks and eat foods that you cook, eat foods that come from the ground or come from farms, and not ultra pre-processed foods.
And these are some basic things we need to incorporate in the new nutrition guidance. The food pyramid has done tremendous damage. It’s come from embarrassingly, the government, and it’s done a tremendous amount of damage.
It was written by the industry, not based on what’s healthy for you, but based on what they wanted you to buy. And we’re redoing that guidance.
There’s nothing wrong with natural saturated fats for the vast majority of Americans.
And so we’ve got to change our focus to the chemicals in the food supply and the ultra processed foods that’s now 70% of the diet of children.
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Marty Makary, FDA [00:08:41]
Hormone replacement therapy, that is estrogen or estrogen plus progesterone, when started within 10 years of the onset of perimenopause can have tremendous health benefits, not just in the short term with relieving hot flashes and difficult sleeping and weight gain and mood swings, but also long term health outcomes, reducing osteoporosis and reducing cognitive decline. Even Alzheimer’s, long term, and reducing the risk of fatal heart attacks.
These are tremendous health benefits, but sadly 50 million women have been denied hormone therapy or not offered it because of a study in 2002 that suggested it increases the risk of dying of breast cancer when that actual study did not show an increase in breast cancer mortality and subsequent studies have not shown an increase in breast cancer mortality.
There’s no clinical trial that shows hormone therapy, when started within 10 years of the onset of premenopause, increases breast cancer mortality. And so, we’re going to convene experts to talk about the latest evidence, address the dogma and ask, what can we be doing about at the FDA regarding the current warning label on the drug that it increases the risk of breast cancer.
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Marty Makary, FDA [00:10:47]
We need to streamline the regulatory process for drugs, for devices, for new technologies.
We want to see more cures and meaningful treatments for the American public and more powerful diagnostics, like the continuous glucose monitors that people wear to understand how their pancreas responses to sugar and what gives them a sugar high and what doesn’t give them a sugar high in their diet.
So we’re going to keep going.
On background to an HHS spokesperson: In April, staff who were identified as part of a reduction in force were placed on paid administrative leave. Consistent with other HHS components, ACF has returned to work status limited personnel to support the effective transition of operations. Last week, ACF contacted a small number of grants management staff to inform them that they may be required to return to a work status to complete such transition activities, however no grants management staff have been returned to a work status at this time.
Marty Makary, FDA [09:37:00]
The promise of Secretary Kennedy is to let people know that vaccines will be available, if people want them. You will be able to get a vaccine if you want them.
So that’s a decision between you and your doctor and each individual insurance company has their own policy.
Look, some insurance companies don’t pay for important cancer treatments that I– for patients that I saw as a cancer surgeon. And so that is another entire issue that’s unrelated to the FDA.
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Marty Makary, FDA [09:42:32]
So it’s a large unmet public health need. It is a priority identified as part of a U.S. domestic national priority, like the domestication of manufacturing, as a national security issue.
And look, the president is very adamant that he would like to see lower drug prices for Americans. And he doesn’t like it, that Americans are getting ripped off with drugs that are two, five, ten times higher in the United States than in London or France or Germany, other OECD countries.
So we are including the affordability of drugs as a national priority.
So we have a committee that’s set up that will determine which products and companies will get these vouchers as a part of a pilot.
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Question [09:49:16]
When can you come back?
Marty Makary, FDA [09:49:19]
I love your show. I’d like to see a fewer direct to consumer drug ads on your show, but I’d love to –
Question [09:49:27]
I was just going to– I was going to say, I want to talk to you about that because I still want this purple pill that that’s on nightly news every night. I don’t know what it does. I have no idea, but they make me want it so much. I’ve been bugging my doctor, give me that purple pill.
I mean, it’s crazy doctor. Why do we– if your doctor need– if you need something, does the doctor need to be sold on something on TV for him to prescribe or her to prescribe the right thing for you? What’s what’s the whole rationale behind all these things? All I know about are– all over my body. That’s all I know from these things. And I see people, overweight people marching along the street, where are they going? What are all these things? And why do we need them?
That’s my rant.
Marty Makary, FDA [09:50:13]
Yeah, they’re always singing and dancing. They’re always singing and dancing.
And we have our regulation at the FDA.
And I know sometimes you’re at home, totally healthy, you just came back from the gym and you’re watching these ads nonstop and you want to say, okay, I give up, I’ll take it. I’ll take it. I don’t know what it is.
Question [09:50:28]
I know. I don’t know what it is, but I don’t want it.
Marty Makary, FDA [09:50:31]
Look, there’s a regulation that says there should not be a misleading impression from these ads. And so we’re taking a hard look at that.
From: A Message from the Office of Human Capital Management
Sent: Wednesday, July 9, 2025 12:37 PM
To: FDA-Wide
Subject: Calendar Year 2024 Performance Management Appraisal Program (PMAP) Award Guidance
Calendar Year 2024 Performance Management Appraisal Program (PMAP) Award Guidance
To: All FDA Employees
ACTION REQUESTED: FDA employees with a 2024 performance rating of 3.1 or higher must select their PMAP award preference (cash, time-off, or combination) within 3 business days of this guidance’s email issuance via the ePMAP Tool (NLT COB Friday, July 11th), or a cash award will be given by default. Only employees who are not scheduled to separate, via voluntary or involuntary program, will be eligible to receive a PMAP Award. Ratings determine eligibility and limits for award types in accordance with FDA guidance below. Detailed instructions on choosing your award type is available here: Employee Award Finalization. If you have already selected your award type, your selection is final and you may not request to change it.
Performance Awards Pools: Employees must have an FDA performance rating to receive a performance award from FDA’s performance award pool. Employees who separate from the FDA (including but not limited to: retirement, resignation, or reassignment), or convert to Executive or Commissioned Corps appointments before the pay period of the awards payout will NOT receive an award. o Employees on administrative leave due to accepting the Deferred Resignation will NOT be eligible to receive a performance award. o Employees who have received notification that their position is impacted by the Reduction in Force will NOT be eligible to receive a performance award. Monetary Award Pool Allocations* 2 AFGE and NTEU Bargaining Unit Employees Non-Bargaining Unit Employees 85% toward Rating-Based Awards (PMAP Awards) 80% toward Rating-Based Awards (PMAP Awards) 15% toward Incentive Awards 20% toward Incentive Awards *Any remaining cash funds after rating-based awards have been proportionately awarded may be reallocated to the incentive award pool. Employees may request their award payout preference of either a cash award, time-off award, or combination award. The selection of “combination” will result in the award being equally split between time-off and cash. Employees may visit the FDA Performance Management Program Performance Award Payout Estimator page to calculate their estimated award at the maximum.
Performance Awards: Employees with a 3.1 annual rating score and above are eligible for a cash award. Employees with a 3.0 annual rating score and above are eligible to elect a time-off award in lieu of cash. Employees with an annual rating score of 3.0-3.09 may receive a time-off award but are not eligible for a cash award. Time off awards will be based on the “cash equivalent value” of the cash award that would have been given as a result of the employee’s annual rating score. If the cash equivalent value exceeds the number of hours available to you, the remainder will be awarded as cash if you are eligible to receive cash. Time-off awards are limited per employee to 80 hours per single accomplishment/contribution and cannot exceed 100 total award hours in a calendar year. Time-off Awards received through the incentive awards program count against the 100-hour maximum an employee may receive in a single leave year; therefore time-off incentive awards already received before performancebased awards are processed may impact the number of hours an employee may receive as a performance award. Please note time-off awards do not pay out in cash if you separate from FDA prior to using them. Employees with a 3.1 annual rating score and above are eligible for a combination award.
Quality Step Increases (QSIs): A QSI is a faster-than-normal within-grade increase (WGI) used to reward General Schedule (GS) employees, including Title 38 Medical Officers, at any grade level who display high-quality performance.* Employees who receive an Achieved Outstanding Results (AO) summary rating may be eligible for a QSI. Management will make the determination which employees will be approved to receive a QSI as their rating-based award. To be eligible for a QSI, employees must: o Be below step 10 of their grade level; o Have received the highest annual rating score of Achieved Outstanding Results (4.5-5.0); 3 o Have demonstrated sustained performance of high quality; and o Have not received a QSI within the preceding 52 consecutive calendar weeks. Quality Increases (QIs): Title 21 employees who display high-quality performance are eligible for Quality Increases with eligibility consistent with the guidance outlined above for QSIs. Performance Award Pool Tier Levels: For each award pool, there will be a consistent percentage used to determine the award value for each tier level. Below are the maximum award percentages for each tier and pool. Please note the payout percentages for both NBUEs and BUEs remain the same as last year. Last year, both AFGE and NTEU decided to allocate more funds towards PMAP awards instead of incentive awards, therefore it was determined the maximum award percentages could increase. If sufficient funds (e.g., for “cash equivalent” purposes) are not available using the maximum award percentages for each tier, then the pool will be balanced by reducing the percent payout for all tiers proportionately.
CY24 PMAP Awards - Tiered Payout PMAP Score Range Non-Bargaining Unit Pool: 80% Bargaining Unit (AFGE and NTEU) – Pool 85% AO-1 Score of 5.0 4.25% 5% AO-2 Score Range of 4.5 – 4.99 3.75% 4.50% AM-1 Score Range of 4.1 – 4.49 3.25% 4.00% AM-2 Score Range of 3.6 – 4.09 2.75% 3.50% AE-1 Score Range of 3.3 – 3.59 1.50% 2.25% AE-2 Score Range of 3.0-3.29 1.25% 2.00%
This guidance is applicable to all FDA non-executive employees, including Title 21, Title 38, and Title 42.
Sincerely,
Performance Management and Awards Staff
Office of Human Capital Management
Hey guys, hope you had a good Fourth of July and a nice break. We had a great workshop today on reducing animal testing and the NAMS, and that’s going great. So that was a great event today. Over 1000 folks also live streamed to the public so everybody can see what we’re thinking and what we’re doing, also on the PMAP performance awards. That has been such a problem, it’s been held up, and we finally figured out what the block was, and we were able to fix it. It was a problem deep in the bureaucracy of government, outside of FDA, we were able to fix it, and so people will be getting their PMAP performance awards in the next couple weeks by the first week of August at the latest, I’m told, sorry for the delay. It shouldn’t have happened, and I’m just glad it’s going to go through. This is for 2024 it’s overdue, but wanted to give you a quick update on that. So that’s it for now. Thanks again for all your hard work and continue to flag anything for us that we can work on on your behalf. We’ll continue to advocate for you.
Robert Malone, ACIP [00:33:22]
This is just for context. I personally lost two jobs, in the past, working in the influenza industry, influenza vaccine industry, for even raising the issue of negative effectiveness of immune imprinting and of original antigenic sin.
The last two being really all three of those being very technical terms that have to do with the issue of whether or not taking this type of product year after year after year is– makes good sense immunologically, or whether doing this year after year after year is somehow imprinting one’s immune system in ways that are, just to simplify it, counterproductive or mounting a effective immune response against a new strain your body may not have encountered in the past.
Basically, it’s as if we’re training the army– you know, you can build a strategy based on the last war and functionally that’s what happens with influenza vaccines, is it’s teaching your immune system to fight the last war largely.
And it– there are data and it’s been a hot subject of debate in the vaccine community now for decades, whether or not, one, this strategy of annual boosting or in the case of the COVID product, much more frequent than annual, is actually counterproductive, that it’s driving the immune system towards categories of responses that are counterproductive.
…
Robert Malone, ACIP [00:35:57]
Now Retsef is going to chair the COVID subcommittee. So this is super important because it means he’s going to be in charge of setting the agenda for what gets discussed about COVID and the various COVID products and how they’ve been evaluated going forward.
He hasn’t had that opportunity in the past, but now he does have that.
And I find myself having been positioned as chair of the influenza vaccine committee.
So I mentioned in the meeting that it’s my intention, that these issues of immune imprinting, original antigenic sin, etcetera, will be discussed and strongly considered in upcoming meetings.
In terms of the decision that we were faced, we were presented with essentially language that was already approved and had to make a decision about whether or not to endorse both those specific virus strains that had been vetted thoroughly and to endorse a universal influenza vaccine recommendation as has been the case for decades.
And the decision was that this was not the time to fight on that hill about the universal influenza vaccine recommendation.
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Robert Malone, ACIP [00:49:30]
There are some that suggests that the COVID products are causing various types of damage to the immune response that’s leading to a susceptibility to one of the most common immunologically controlled diseases that we’re all familiar with, which is cancer.
And so the question came up and I asked it very gently whether the ACIP is tracking these issues, whether they have the data to support or refute these hypotheses. And the answer is no, they don’t.
So I hope that we as the ACIP going forward, frankly, my impression is that a lot of the thinking at the CDC in terms of these monitoring and analyses routines that they get into are a bit antiquated.
They’re kind of old school to use common slang. And, I think personally that the CDC will be well served, and so will the public, to start incorporating in their analyses newer frontline concepts about immune response.
The idea that Dr. Prasad “overruled” FDA scientists is a distortion of the facts. He evaluated the totality of the evidence and made a judgment rooted in gold standard science. That’s not political—it’s what principled leadership looks like.
The reality is that the FDA has never permitted manufacturers to claim COVID-19 vaccines prevent Long Covid, because such a claim is not supported by high-quality evidence. While critics selectively cite fringe fears or speculate, the FDA will continue to follow the science and use evidence-based decision making. No honest scientist can claim that another booster for a healthy young adult meets that standard today.
Dr. Prasad is pursuing a course correction to bring U.S. policy in line with the rest of the developed world. That correction requires thoughtful review and clear documentation, not blind repetition of outdated frameworks. Dismissing this process as “cherry-picking” ignores the obvious: science evolves, and so must our policies.
Dr. Makary’s decision to elevate Dr. Prasad reflects the need for coherent, accountable leadership at the top of FDA. The consolidation of titles isn’t political—it’s a long-overdue response to years of fragmented decision-making that often lacked evidence-based judgment. Dr. Prasad’s leadership marks a return to scientific integrity—not a departure from it.
Let’s also be honest about who the loudest critics are. Many of the same so-called experts being quoted today are the ones who pushed policies that have since collapsed under scrutiny—advising cloth masks for toddlers or insisting that children receive dose after dose of a vaccine with no individualized benefit-risk evaluation. Their record speaks for itself. And if we’re talking about politics in vaccine policy, we should recall the rushed BLA approval under the Biden administration, which triggered mandates for millions—including those who already had COVID—and contributed to unnecessary adverse events like myocarditis. That disastrous move led to the resignation of FDA’s top two vaccine officials and remains one of the most damaging missteps in modern public health history.
Dr. Prasad is correcting course with data, with transparency, and with the courage to say what others won’t. That’s how trust in science is rebuilt.