If you want to get a sense a sense of how vast and concerning the problem with the U.S. Food and Drug Administration is, where do you start?
A 2022 investigation by the journal The BMJ declared that FDA oversight of clinical trials, including those for Pfizer and Moderna's mRNA Covid-19 vaccines, was "grossly inadequate," from not conducting enough inspections to failing to alert scientific journals or the public when violations were flagged.
In December, the results of an 18-month congressional investigation into the FDA's conduct, allegedly "rife with irregularities" approving the Biogen costly Alzheimer's drug Aduhelm were released. The report assessed that the agency's actions "raise serious concerns about FDA's lapses in protocol" in its "atypical collaboration" with the drug maker and advised that the FDA "must take swift action to ensure that its processes for reviewing future Alzheimer's disease treatments do not lead to the same doubts about the integrity of FDA.'s review."
The efficacy of the drug is still debated, and it is not approved in Europe.
But the issues here are not confined to behind the pharmacy counter. In February, the FDA announced a voluntary recall from Global Pharma Healthcare on their Artificial Tears Lubricant Eye Drops "due to possible contamination." In a confusingly worded statement, the agency warned of "the risk of eye infections that could result in blindness," but also noted there had been "a death with a bloodstream infection." In the weeks that followed, other eye drop brands were added to the list of potentially contained products, and the toll rose to "14 patients with vision loss, an additional 4 patients with enucleation (surgical removal of eyeball), and 4 deaths."
And as Peter Robison and Priyanka Pulla explained recently for Bloomberg, these were drops that "were made in India and sold by two US distributors in boxes stamped with the drug inventory numbers that the Food and Drug Administration issued."
There's more. In April, a research letter published in JAMA raised issues over the "Quantity of Melatonin and CBD in Melatonin Gummies Sold in the US." Examining 25 readily available brands of melatonin gummies, researchers found "nearly all of the products had more than 10% more melatonin than advertised." One product contained 347% more. Another contained none, but did contain cannabidiol, also known as CBD, a drug derived from cannabis, yet another medication that the FDA has been pushed by lawmakers to regulate.
"The regulatory framework for supplements is broken," study coauthor Dr. Pieter Cohen told CNN at the time. "The manufacturers are not complying with the law, and the FDA is not enforcing the law. So what that means is that we have a lot of poor-quality products out there."
You get the idea. How did we get here? Why is the system that's supposed to protect us from unsafe prescription and over the counter medications seemingly so broken? There is no single, simple answer, but you can see the cracks more clearly in a few places.
Dr. John Abramson, author of the recent book "Sickening: How Big Pharma Broke American Health Care and How We Can Repair It," traces the roots of issue back decades. "In 1992, when what turned out to be effective HIV drugs were stuck in the bottleneck of the FDA, they didn't have enough staff to get them through quickly enough. Many people were dying, and it was a real crisis," he explains. "The solution was that the Prescription Drug User Fee Agreement was passed. The drug companies started to pay a user fee with that was due upon application for new drug approval. And now roughly 65% of the FDA budget for overseeing human products comes from the drug and device companies. This comes with rigid timelines, and as I see from the outside, some degree of influence and obligation to the drug companies that derives from this agreement."
The numbers here vary — Forbes puts that budget figure as high as 75%. But the question, as C. Michael White asked for UConn Today in 2021, remains, "Why is the FDA funded in part by the companies it regulates?"
Another similar conflict of interest that concerns Abramson is what he calls "the revolving door that goes between FDA and the drug industry." For example, he says, there's the agency's former commissioner, Stephen Hahn. "He was calling the shots through Trump's presidency," Abramson notes. And then, "Five months after leaving government, Hahn went to work in a high position at Flagship Pioneering, a biotech private investment firm. They actually own a significant chunk of Moderna. Hahn going from the FDA to Flagship Pioneering is a perfect example of the revolving door that is likely to give Flagship Pioneering a leg up as it goes forward in its investments in new biotech products."
But Arthur Caplan, PhD, NYU Grossman School of Medicine's Department of Population Health, thinks that consumer and patient demand have also led us down this path.
"The FDA is getting told more and more by Congress to speed up approvals, to listen harder to what I'll call weaker evidence," he says. "They're trying to swim upstream against a movement that began with the Right to Try movement, which basically said, 'We want to have less worry about risk, less worry about safety and more right to access what we, as patients or patient families, want to do.'"
Caplan thinks "The culture has shifted so that there's much more emphasis on personal choice and autonomy. You see it all over our politics, but it's cascading over the FDA too to say, 'Stop trying to be protecting us. Your job is to let us get access to what we want, because we as citizens should have the right to take the risks we want to take to pursue the options we want to pursue.'"
There's a certain circularity to Abramson's and Caplan's perspective. Thirty years ago, public demand spurred a major shift in drug development and in the FDA. Now, it seems to be a factor in its current controversies and concerns over its competence. And Arthur Caplan is not optimistic the situation is going to get any better.
"It used to be the FDA's job was watch closely on safety, to listen hard to panels of experts about their opinions, based on best available evidence," he says. "Now, the message is clear from politicians, from patient advocacy groups, even the general public, 'We don't want paternalism; we want individual choice. We want liberty. We are less interested in what experts tell us. I don't think this is anything to do much with the pharmaceutical industry, or positions that are being taken by scientists. I think," says Caplan, "it's about much bigger cultural change in America."
