A month ago, the Food and Drug Administration was hit with large reductions in force (RIFs). Even though about half of the agency’s budget now comes from user fees paid by the pharmaceutical industry, probationary employees were dismissed. Food safety staff and workers in medical device oversight were especially hard hit. There were even questions about water safety at some facilities. Should you care about all the FDA fumbles and firings?
We have been hard on the Food and Drug Administration, as you will shortly read. But without the FDA looking at food safety, drug and device safety and so many other critical health activities, we would quickly return to the days of the snake oil salesmen. The FDA stops some of the worst abuses by big Pharma. But many visitors to this website have advocated for the elimination of the agency. They have no idea what would happen if that were to occur.
Just imagine if health hucksters could sell anything they wanted to whomever they wanted whenever they wanted. What if drug companies were given even more freedom to advertise prescription drugs? This giant industry would quickly take over television, radio and the Internet. Manufacturers could use any type of material to make implants for knees, breasts or hips, with no oversight. They would very likely downplay or omit mention of medication side effects.
When Oversight Vanishes, Danger Takes the Wheel:
Without stoplights, speed limits or traffic cops, imagine what driving would be like. Now imagine the safety of your food and medications without FDA oversight. Side effects? No one would collect such information or make it available to prescribers or patients.
If your chicken were to be contaminated with salmonella, no federal organization would alert you or require the manufacturer to recall the contaminated packages. If an unscrupulous pet food maker included ingredients that harmed dogs and cats, no one would have the ability to detect the problem or recall the poisonous products.
You are about to read about our problems with the FDA, but hamstringing the agency, firing employees and relocating them to unusable offices is hardly the solution to our ongoing challenges.
My Relationship with the FDA:
I have been writing about the U.S. Food and Drug Administration for more than 50 years. In my second book, The People’s Pharmacy-2 (Avon Book, 1980) I acknowledged that the inspiration for the book was in part thanks to:
“Dr. Jere Goyan, the best damn Commissioner of the Food and Drug Administration this country has ever had!”
In those days I was an admirer of the agency because it was dedicated to proving that medications were both safe and effective for the American public. Dr. Goyan had been dean of the University of California, San Francisco (UCSF) School of pharmacy before leading the FDA.
The New York Times described him this way on November 7, 1979:
“The first pharmacist ever to head the Food and Drug Administration believes that Americans use too many prescription drugs and says he is determined to use his new post to persuade them to cut down.
“‘Too many people in this country are taking too many drugs without proper understanding of their potential harmful effects,’ the new Commissioner of Food and Drugs, Dr. Jere E. Goyan, told a breakfast gathering of reporters today at the National Press Club. ‘Our society has become overmedicated.’”
“He indicated that he planned to push ahead strongly with a controversial agency proposal to require easy‐to‐read package inserts for hundreds of prescription drugs to tell consumers about what they are taking.”
“‘I would not want to swallow a pill about which I knew nothing, and I would not expect anyone else to do so either.’”
“‘Americans must learn there is not a pill for every ill, and that they need not get a prescription every time they visit their doctors.’”
Jere Goyan and Joe Graedon Became Friends:
You can understand why I appreciated Dr. Goyan. We shared a strong belief that Americans deserved objective and complete information about the medications they took. That was why The People’s Pharmacy books resonated so profoundly with the public.
Until those books, drug information was kept a deep, dark secret. The PDR (Physicians’ Desk Reference) was not sold in bookstores. People could not easily get their hands on this drug reference. There was no internet and no way that people could learn about drug side effects or interactions.
Despite tremendous resistance from health professionals, Jere Goyan began opening the window to drug information. We were allies in an effort to provide the public with objective pharmaceutical facts. There were no prescription drug ads on television! Jere would be turning over in his grave if he saw the commercials for pharmaceuticals that populate television and the Internet today.
Fast Forward Several Decades to FDA Fumbles:
The Food and Drug Administration has changed dramatically since the days of Dr. Goyan. Terry and I have become fierce critics of the Food and Drug Administration.
Nowadays many of the leaders of the agency have come from the pharmaceutical industry or go to work for the pharmaceutical industry once their FDA tenure is over. It’s called the revolving door between Big Pharma and the FDA. Want details? Here is a link to a recent article titled:
Do You Have Confidence in the FDA? Has This Watchdog Lost Its Bite?
A revolving FDA door allows leaders from Big Pharma to head the FDA and then return to industry. Does that give you confidence in the FDA?
A HUGE FDA Fumble on Prescription Drug Ads:
We have written way too many articles about what we think is one of the FDA’s biggest boondoggles: opening the floodgates to prescription drug commercials. Here is just a smattering of our outrage:
Are Prescription Drug Ads on TV Driving You Crazy?
If you are fed up with drug commercials, you are not alone. Even doctors have reached their limits.
People Are Having Too Much Fun on Drug Commercials!
We find drug commercials incredibly misleading? So do many readers. They’re hard to avoid! Will the FDA finally clamp down on distorted ads?
Getting Television Drug Commercials Under Control!
The FDA just published a “guidance” for the makers of television drug commercials. Can the FDA put the Big PHARMA genie back in the bottle?
I told you that I had written too much about prescription drug advertising. Sorry, but it makes my blood boil!
The Greatest Con of All: FDA Fumbles Drug Effectiveness & Safety
We have challenged the Food and Drug Administration on its claim that it only approves drugs that are safe and effective. All you have to do is watch a drug commercial that lists heart attacks, strokes, cancer, kidney damage and death as potential adverse drug reactions to realize that the word “safe” is a lot like this interchange between Alice and Humpty Dumpty in Lewis Carroll’s book, Through the Looking Glass:
“When I use a word,” Humpty Dumpty said in rather a scornful tone, “it means just what I choose it to mean—neither more nor less.”
“The question is,” said Alice, “whether you can make words mean so many different things.”
“The question is,” said Humpty Dumpty, “which is to be master—that’s all.”
The World of “Evidence-Based Medicine”
Modern medicine has embraced the concept of EBM (evidence-based medicine). The FDA stands at the top of this pyramid. It seems so scientific and so reassuring. Doctors only prescribe “proven” medications. What the FDA is not very good at is explaining actual effectiveness that people care about
The agency can tell you that drug X is statistically superior to placebo and therefore worthy of FDA approval. What it does not wish to tell you in understandable language is whether drug X will help you in any meaningful way.
Just take a few minutes to read my recent article on antidepressants to understand why this is important:
Trapped in Treatment: How Antidepressant Research Ignores Withdrawal
Is there an antidepressant trap? Antidepressant research rarely lasts for more than 8 to 12 weeks, yet patients take such drugs for years.
It is estimated that 44 million Americans take antidepressant drugs, but how effective are these medications?
Even more alarming is FDA’s approval of anti-amyloid medications for Alzheimer’s disease:
The Evolving Scandal Surrounding Anti-Amyloid Alzheimer’s Drugs
An expose from the New York Times reveals that drug companies making anti-amyloid Alzheimer’s drugs did NOT reveal a risk for brain bleeds.
Drug Safety Is a Myth:
The FDA is supposed to protect us from pharmaceutical harm. It has failed! Here are just a few examples:
How Safe and Effective Are Your Medicines? You Might Be Surprised!
Is your medicine safe and effective? How would you know? The FDA says a drug is “safe” even if it can cause cancer, heart attacks or death.
Is Drug Side Effect Information Trustworthy?
How reliable is drug side effect information? Learn about flaws in how the data are collected. The FDA & drug companies “miss” an awful lot!
Final Words:
If We Are So Critical of FDA Fumbles, Why Are We Worried About FDA Chaos and Cutbacks?
We have criticized the Food and Drug Administration for lots of shortcomings. And that doesn’t even take into account our concerns about generic drug quality. Far too many critical medications are made in factories abroad where quality takes a back seat to the bottom line and FDA inspections are inadequate.
All that said, most of the people who work at the Food and Drug administration are dedicated to public safety. They work hard for less money than private sector employees. There have been firings and rehirings that have created chaos. When working conditions become so challenging, key people leave for industry where salaries are better and working conditions are less daunting.
Return to Work Confusion:
Thousands of FDA employees returned to work this week. Many of the workers who had been fired were reinstated. They found chaos because parking lots were filled over capacity, while offices were scrambled and under-equipped. Many FDA employees had to scrounge chairs, desks and computers.
STAT+ reports on a wide range of topics, especially biotech, Pharma and public health.
An article by Lizzy Lawrence (March 17, 2025) describes return-to-work at the agency:
“Morale at the agency is already low, eight agency sources said.
“FDA needs to make some kind of exception if we want to retain the talent,” one agency source said. “People are not going to be able to tolerate being in a conference room with 20 people for your job all day. That’s not feasible. I won’t be surprised if people start dropping like flies.”
“Finding a spot to discuss medical product applications, which sometimes contain trade secrets or other proprietary information, will be difficult.”
We do not need to force cutbacks at the Food and Drug Administration. If anything, Americans need to spend more on this critical agency.
Are you not outraged that over 90% of our generic drugs come from abroad? Only 4% of the active pharmaceutical ingredients in such medicines are made in the United States. And because the FDA does not have the resources or personnel to investigate all foreign manufacturers in a timely manner, there have been far too many mistakes and fraudulent behavior at foreign drug companies.
The FDA’s budget is somewhere in excess of $7 billion. Over $3 billion of that (~45%) will come from the drug and device industry the agency is supposed to regulate. I find that outrageous. The American public should pay for the regulation of an industry that rakes in over $600 billion!
Crippling the FDA:
Why FDA Fumbles Are No Excuse to Weaken the Agency
You clearly recognize that I have been highly critical of the Food and Drug Administration. FDA fumbles are disappointing. But making working conditions difficult and stripping the watchdog of its power would not improve our health. If anything, we need a bigger and better watchdog with teeth that bite.
Instead of taking money from the industry it regulates, the FDA should be fully funded by American taxpayers. Prescription drug commercials should be eliminated from television and the Internet. Drug companies should be incentivized to make medicines in the US instead of rewarded for outsourcing medication manufacturing. I could go on and on, but you get the idea.
The Risks of Sabotaging the FDA:
I would like to return to my driving metaphor for just a moment. Would you drive a car on roads where there were no rules? What if anyone could get a driver’s license without passing a test? If there were no speed limits, you could be passed by cars going 120 mph. If there were no stop lights, imagine trying to get through an intersection.
Would you feel safe driving in a country where car manufacturers were not accountable for faulty brakes? What if your car caught fire and you could not sue the company that caused the chaos?
Most people do not realize that they cannot sue a drug company if they are warned that its medication could cause heart attacks, strokes, cancer or death. That’s because medications are usually categorized as “unavoidably unsafe products.” If the official prescribing information or a TV commercial warns that a medicine can cause a long list of horrible side effects or death, forget about litigation. More about this here.
We need to fix the FDA, not cripple it. Please share your thoughts in the comment section below. If you think this article is worthy, please pass it along to friends and family. Thanks for your support.
