Crises at the Food and Drug Administration

And a reminder of why we need a functional FDA

We take for granted that the Food and Drug Administration (FDA) will ensure that prescription drugs are safe and do what they claim to do. Unlike most over-the-counter products that are “cleared” for use (I’m looking at you, Nutrafol™ and Prevagen™), an FDA-approved product requires clinical trials to establish efficacy, appropriate dosage, and possible side effects.

Every year, roughly 50 new drugs are FDA-approved, including generic drugs and “novel” drugs that are developed to treat specific conditions. In 2024, ten new drugs were “fast-tracked” to treat cancer, including pediatric brain cancer.

But don’t expect to see that kind of innovation in the next year, given that 3,500 jobs were just cut at the FDA.

While the White House claims that the layoffs did not target product reviewers, that is irrelevant. Scientists who must determine if a drug is safe and effective can't do so without a support staff. No surprise, hundreds of key personnel who were not fired are now quitting or have recused themselves from key projects since they can no longer do their jobs properly.

The FDA does not conduct clinical trials or test new drugs—it just reviews them and, in most cases, requests additional information before final approval. What that means is that many clinical trials (the ones that are still funded) have come to a standstill while they await feedback from the FDA, which they are unlikely to get.

Another role of the FDA is to inspect factories in other countries that manufacture drugs that are exported to the US, to ensure quality control of the product you ultimately pick up from your local pharmacy. Most of the FDA inspectors who investigate drug factories overseas have been fired. The ones that remain are no longer able to travel to those factories. According to NPR, “A March 11 email to FDA staff says the administration lowered government employee credit card limits to $1. Now to book travel, inspectors need prior approval to get the credit limit raised. The drug inspector said the administrator they had emailed for authorization had been laid off. "It's hard to believe the work is actually going to get done," the inspector said.”

Bottom line- the Musk/Trump chainsaw now leaves us without a functional FDA.

It’s not just about the approval of new drugs. There have also been drastic cuts within the Office of Generic Drug Policy, which regulates the availability of safe and effective generic drugs to the public. Between these FDA cuts and the expected unavailability of essential ingredients due to tariffs, which I wrote about here, the consumer can expect drastic reductions in the availability of both brand-name drugs and low-cost generic substitutes.

The current FDA is far from perfect.

Drug approval is an extensive and expensive process that prevents many drugs from getting to the public.

On average, from when the drug is first developed to being available to the patient takes 12-15 years and costs in the neighborhood of 1-2 BILLION dollars. Most drugs never make it to the pharmacy.

FDA warnings that are inaccurate, such as the curent warnings on local vaginal estrogen products, are also highly problematic.

But, as flawed as the current FDA is, things are much better than before it existed.

A Return to the Pre-FDA ERA?

Since it appears we are returning to the 1800s, not just in terms of women’s reproductive rights, but also in terms of drug safety, I think it is worth taking a look at what things were like before there was an FDA.

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The initial Food and Drugs Act, passed by Congress in 1906 and signed by President Theodore Roosevelt, was to control interstate commerce of misbranded and adulterated foods, drinks, and drugs. Unlike today, there were no requirements to establish the safety or efficacy of drugs and products.

Although commonly included in over-the-counter products, labeling did not warn consumers about the presence of alcohol, heroin, cocaine, morphine, or opium.

Clinical trials of medications before release did not exist. There were no studies in which people would take a new drug and compare it to people taking a placebo drug to prove that it worked and that it was safe. New drugs were released to the public by the manufacturer, based on their claims that they would treat an illness or condition. Which sounds a lot like what currently happens in the over-the-counter and compounding world.

There was some informal testing, but it was pretty random. It wasn’t unusual for physicians to try a new drug on themselves first. There is even documentation of male doctors taking estrogen just to make sure nothing bad happened.

No surprise- with minimal or haphazard testing before selling a new drug, bad things did happen.

In 1912, Mrs. Winslow’s “soothing syrup to calm teething babies” was extremely popular. Unfortunately, the active ingredients, morphine and alcohol, made it a little too soothing, resulting in thousands of deaths. Children went to sleep and never woke up. It took years to determine that “The Mother’s Friend” was what was killing their babies.

That disaster prompted the passage of the Sherley Amendment, which prohibited labeling medicines with intentionally false claims. Again, at this time, no testing or proof was required before the release of a product.

In 1937, another disaster occurred. A popular sulfa antibiotic, Elixir Sulfanilamide, laced with diethylene glycol, otherwise known as antifreeze, killed over one hundred people, including many children. Here is one doctor’s account of his experience:

"But to realize that six human beings, all of them my patients, one of them my best friend, are dead because they took medicine that I prescribed for them innocently, and to realize that that medicine which I had used for years in such cases suddenly had become a deadly poison in its newest and most modern form, as recommended by a great and reputable pharmaceutical firm in Tennessee: well, that realization has given me such days and nights of mental and spiritual agony as I did not believe a human being could undergo and survive. I have known hours when death for me would be a welcome relief from this agony." (Letter by Dr. A.S. Calhoun, October 22, 1937)

And then there was “Lash Lure,” an eyebrow and lash dye that, in a major Oops!, dissolved corneas and blinded over a dozen women. Those that were not blinded developed “horrific blisters, and ulcers on the face, eyelids and eyes. ..One woman developed a bacterial infection and died”.

Those kinds of disasters prompted the Food, Drug, and Cosmetic Act of 1938, which required new drugs to be “approved” before marketing. This was the beginning of the modern FDA. For the first time, drugs had to be tested before they were brought to market to make sure they were safe. In addition, drugs had to be labeled with specific directions. We take for granted that when we get a prescription, it tells us how much to take and how often to take it. But before 1938, those kinds of directions did not exist.

This was also the beginning of requiring a prescription for drugs. People could no longer walk into the corner drug store and request any medication they wanted. Notice I didn’t say anything about a drug proving that it worked. At that point, FDA approval did not require that a drug be proved effective, only that it would not cause harm. It was not until 1962 that a drug had to establish efficacy through clinical trials to gain FDA approval.

Today’s FDA is far from perfect, but at least you know that if a drug is FDA approved to help hot flashes, it has demonstrated that it will do so, how well it will work, how much to take, and any possible side effects. And, while the process is slow and expensive, new drugs are hitting the market all the time, which is why survival rates for cardiovascular disease and cancer continue to improve even though there is more cardiovascular disease and cancer than ever before.

It boggles the mind that our government is sabotaging a system that, while not perfect, at least offers protection that new drugs are approved, and equivalent generics are available. The drugs that show up at our pharmacy have been inspected for consistency and purity instead of taking our chances that the dose in the bottle matches the label and our antibiotics are not tainted by rat droppings or antifreeze.

Need more convincing? Check out this video about the 1933 traveling exhibit to educate consumers about dangerous, deceptive, or worthless products that the FDA lacked the authority to remove from the market. And maybe send a copy to your state representatives.