On November 28, 2024, I was pleased to announce that: “President-elect Trump has nominated a Johns Hopkins surgeon, Dr. Martin Makary, to lead the Food and Drug Administration. Can he create a new era of transparency and innovation at the FDA and possibly even transform medicine in the process?” A year and a half later, Dr. Marty Makary resigned/was fired by President Donald Trump!
Which was it? Resigned or was fired? That’s somewhat confusing. A May 8 New York Times headline was titled:
“Trump Plans to Fire F.D.A. Commissioner Marty Makary”
A May 12, New York Times headline offered a different perspective:
“The agency’s top food official will step in to the role after Dr. Makary privately said he opposed the administration decision to approve flavored vapes.”
“Dr. Marty Makary, the commissioner of the Food and Drug Administration, resigned on Tuesday after weeks of pressure and rumors that President Trump was planning to fire him.
“Dr. Makary ultimately left over concerns about the administration’s decision to authorize fruit-flavored e-cigarettes, an action he opposed, according to four people familiar with the matter. Dr. Makary told those close to him that he could not in good conscience approve flavored vapes, given their appeal to young people, and would not do something he did not believe in.”
The FDA Under Dr. Marty Makary
I was hoping FDA Commissioner Marty Makary would turn out to be one of the great FDA commissioners. That was partly because we had a chance to interact with him on a couple of occasions. He was a guest on our nationally syndicated public radio show/podcast, The People’s Pharmacy. Initially, we interviewed him for Show 934: What Are Hospitals Trying to Hide? Several years later, he appeared in Show 1250: Antimicrobial Resistant Infections Could Be the Next Pandemic. More recently, we spoke to him about his book in Show 1400: Exposing Blind Spots: Unmasking the Myths of Modern Medicine.
Dr. Makary vs. Food Dyes and Drug Commercials
We were excited to read that the Food and Drug Administration was getting rid of Red Dye No. 3. Under Dr. Makary’s leadership, the agency was finally taking action against FD&C Red No. 3 in foods and pharmaceuticals. The FDA was also going after petroleum-based dyes:
- FD&C Red No. 40 (Red 40)
- Blue No. 1
- Blue No. 2
- Green No. 3
- Yellow No. 5
- Yellow No. 6
We wrote in this article that:
“These artificial colors are found in thousands of products. Unless you have been extremely careful and have read every label, I am fairly certain you have been consuming these colors for years. They can be found in sports drinks, cereals, cheese dip, ice cream, hot sauce, salad dressings, mashed potatoes, relish, pickles, candy, mouthwash, cookies, toaster pastries, icings, soft drinks, baby foods and frozen desserts.
“Here are just a few brands that have used such colors in their products:
- Skittles
- M&M’s
- Gatorade
- Froot Loops
- Twizzlers
- Mountain Dew”
Dr. Marty Makary Takes on Drug Commercials!
We were thrilled to learn that the FDA was taking on both the food industry and the pharmaceutical industry over the issue of artificial food dyes. That had been a pet peeve of mine for decades. But even more important was the issue of direct-to-consumer prescription drug commercials on television. Terry and I have written countless articles about these TV ads, to the point that readers were getting exhausted. But most readers shared our frustration with these commercials. So did many health professions.
To see Dr. Makary taking on this industry was refreshing to say the least. At long last it seemed as if the FDA Commissioner was on our side. On September 13, 2025, Dr. Makary wrote a Guest Essay for the New York Times titled:
“I Run the F.D.A. Pharma Ads Are Hurting Americans.”
He started his essay this way:
“American drug advertisements are filled with dancing patients, glowing smiles and catchy jingles that drown out the fine print. It’s not education — it’s distraction by design. This is not how the practice of medicine is supposed to be.
“This week, President Trump and the Food and Drug Administration took action to rein in misleading pharmaceutical ads targeted at consumers. An existing F.D.A. regulation states that ads must not create a ‘misleading impression,’ and that ads must offer a ‘fair balance’ between a drug’s benefits and risks. But many ads today do not abide by these standards. In fact, the most common message seems to be that a drug will instantly transform you into singing and dancing endlessly.”
I was jubilant! At last someone at the FDA shared our concerns about misleading drug commercials. I could hardly contain my excitement…but nothing seemed to change.
My guess is that big Pharma made a lot of phone calls to key players. To this day it seems as if prescription drug ads are as prevalent as ever. With Dr. Makary gone, I am guessing that nothing much will change. I will be amazed if the FDA follows through on its promise to crack down on those drug commercials that most of our readers despise almost as much as we do.
Here is my perspective on the FDA’s lack of action:
Drug Ads’ Death Watch: What Happened to the FDA’s Crackdown?
The FDA Then
I used to be one of the biggest cheerleaders for the Food and Drug Administration. That was decades ago when Dr. Jere Goyan was the FDA Commissioner between October 21, 1979 and January 20, 1981. Dr. Goyan spearheaded initiatives to improve the testing of pharmaceuticals and medical devices.
In those days, patient protection and transparency were high priorities. He led a proposal to provide PPIs (patient package inserts) for prescription drugs so that consumers could have accurate information about their medicines and make better drug decisions. Back then, health care professionals did not make it easy for patients to access such material.
That is why Dr. Goyan and I became good friends. He appreciated my first book, The People’s Pharmacy (St. Martin’s Press, 1976) because it let the cat out of the bag when it came to drug safety. When Terry became a postdoctoral fellow in medical anthropology at the University of California, San Francisco, Jere invited me to lecture at the UCSF School of Pharmacy.
I also became one of the country’s leading advocates for generic drugs. In those days, most affordable generic medications were made in the US. Believe it or not, a great many physicians and pharmacists were skeptical of generic drug quality and promoted pricey brand name pharmaceuticals. I debated a pharmaceutical company representative on Good Morning America and insisted that generic drugs were absolutely equivalent to brand name medicines at a fraction of the cost.
The FDA Now
The Food and Drug Administration has changed dramatically over the decades. Anyone who has been reading our newsletter knows that we have been very critical of the agency because of lack of transparency and uncritical support of generic drug quality.
Over 90% of the generic drugs purchased in the US originate abroad. An analysis from USP Medicine Supply Map (Nov. 6, 2024) reveals that only 4% of our active pharmaceutical ingredients (APIs) come from manufacturing facilities in the US. Most of our medications come from India and China. More details here.
The FDA is supposed to inspect these facilities in a timely fashion. It’s way behind! More alarming, the agency notifies the companies in many foreign countries that it’s planning an inspection long in advance.
Then there are all the drug recalls because of fabricated data, carcinogen contamination, mistakes and poor quality control. We were shocked to learn that a number of clinical testing companies submitted fraudulent data to gain FDA approval for large numbers of generic drugs. Even worse, the FDA would not release the names of the questionable medications on the grounds that the data were “proprietary.” Whatever happened to transparency?
The FDA has an annual budget of more than $7 billion. This year the agency will collect over $3 billion in “user fees” from the drug and device industries it is supposed to oversee and regulate. That’s about 45% of the total FDA budget.
Have you ever heard the expression
“He who pays the piper calls the tune”?
The FDA maintains that user fees:
“…help the agency fulfill its mission of protecting public health and enabling the agency to strengthen its efficiency and increase the speed at which products are available to the public.”
Can you think of any regulatory agency that is entrusted to protect the public health taking money from the very industry it is overseeing? Imagine if building inspectors were receiving nearly half their income from construction firms. Even if the inspectors were absolutely honest, the appearance of such a conflict of interest would be intolerable.
We are less concerned about “efficiency and speed” and more concerned about safety and transparency. We want to see more drug manufacturing in the US. Drug shortages must end! We think that independent drug testing for quality needs to be mandatory. And we want to see “direct to consumer” prescription drug advertising on television curtailed, or better yet, eliminated.
Who Is Dr. Marty Makary?
Dr. Makary has been a guest on The People’s Pharmacy. His latest book is Blind Spots: When Medicine Gets it Wrong and What It Means for Our Health. You can listen to this interview and podcast (Show # 1400, September 19, 2024 titled Exposing Blind Spots) at this link.
You can also listen to another interview with Dr. Marty Makary (Show 1250: Antimicrobial Resistant Infections Could Be the Next Pandemic, May 7, 2024). Dr. Makary also participated in Show 934: What Are Hospitals Trying to Hide? If you scroll to the bottom of the show notes you will find a link to our podcast including the interview with Dr. Makary.
The People’s Pharmacy is reader supported. When you buy through links in this post, we may earn a small affiliate commission (at no cost to you).
Dr. Marty Makary’s Controversial Article in the
Dr. Makary has been an advocate for patient safety, helping to create a surgery checklist to reduce medical mistakes. He has also been critical of the medical establishment and the FDA. In May 2016, he published a powerful analysis with a colleague in the prestigious BMJ (formerly the British Medical Journal). It was titled:
You can read our take on Dr. Marty Makary’s article at this link.
Back before the Secretary of Health and Human Services, RFK, Jr, was confirmed, we asked:
If Dr. Marty Makary Becomes FDA Commissioner, What Can We Expect?
As we explained at that time, we had both hopes and concerns:
Dr. Makary has served as editor of MedPage Today. He is also an executive of a telehealth company called Sesame. One of its main projects has been providing patients with compounded GLP-1 weight-loss drugs. Decisions currently pending at the FDA could well affect the business prospects of the company.
If Mr. Trump’s pick for Secretary of Health and Human Services, Robert F. Kennedy, Jr., is confirmed, the FDA could be in for some substantial changes. For one thing, user fees from the industries it regulates might no longer be such a large part of the Agency’s budget. There is also talk that direct-to-consumer prescription drug advertising might be curtailed. Here is our perspective on drug commercials:
Getting Television Drug Commercials Under Control!
We won’t know if there will be more transparency at the FDA, but we certainly hope so. We also hope that Dr. Marty Makary will push for greater patient safety. For example, we have been strong advocates for alerting patients to boxed warnings.
We asked this question a little while ago:
The FDA has a designation for drug reactions it considers especially worrisome: BOXED WARNING. Do prescribers warn patients? Not always!
We asked high-level executives at the FDA about this issue. The response was lukewarm at best. The agency does not seem terribly interested in requiring health care professionals to alert patients to dangerous medications that carry what is now described as a “boxed warning” rather than the somewhat scarier “black box warning.”
We hope new leadership will take our suggestion seriously to require physicians, nurse practitioners, physician associates and pharmacists to alert patients to this kind of essential information.
Our Hopes for FDA from 2024
Before Dr. Makary was appointed FDA Commissioner, we wrote:
“We hope that if Dr. Marty Makary is approved as FDA Commissioner, he will lead an initiative for greater patient safety, transparency and collaboration with organizations like The People’s Pharmacy. That last suggestion is, of course, unlikely. Although there are many dedicated public servants and smart people working at the agency, the culture at the FDA has been created over decades. It will be challenging to change the course of this massive ship.
“We also hope new leadership will end the revolving door that exists between the FDA and the pharmaceutical industry. You can read about our long-term battle with Gary Buehler, past director of the Office of Generic Drugs at this link. When he left the agency it was announced that he had taken a job as vice president of global regulatory intelligence and policy at Teva, one of the world’s largest generic drug manufacturers.”
The FDA Today
Dr. Marty Makary is gone from the FDA as of this week. He clearly annoyed some powerful people within the food, tobacco and pharmaceutical industries.
The straw that apparently broke the poor camel’s back seems to have been Dr. Makary’s opposition to fruity flavors (mango and blueberry) in e-cigarettes (vapes) that were likely to appeal to youngsters. The administration decided that these flavors were essential and insisted that the FDA approve these products. Not long after, Makary was gone!
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Citations
- Makary, M.A. and Daniel, M., "Medical error—the third leading cause of death in the US," BMJ, May 3, 2016, doi: https://doi.org/10.1136/bmj.i2139
