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?
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. A recent 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 our most recent 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.
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Dr. Marty Makary’s Controversial Article in the BMJ:
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.
If Dr. Marty Makary Becomes FDA Commissioner, What Can We Expect?
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.
Final Words:
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.
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