By Agustin Forzani
Milton and Rose Friedman’s lessons about the flaws of the FDA remain strikingly relevant in the 7-OH case.
The Food and Drug Administration (FDA) is leading a campaign to ban 7-hydroxymitragynine (7-OH), a supplement used for pain relief and to help with opioid withdrawal. The agency argues 7-OH has high abuse potential and points to its growing presence in colorful consumer products found online and in gas stations.
A complete ban, however, would be an extraordinary overreaction. Researchers at Johns Hopkins, Harvard, and UCLA have urged the FDA to reconsider, presenting data showing no signs of overdose deaths or dependence. Pre-clinical studies have found no evidence of toxicity, and even the FDA’s own database shows zero deaths linked solely to 7-OH—despite roughly half a billion doses consumed in the United States so far.
Yet the FDA’s instinct to overreact is nothing new. Despite the DOGE agency’s claims that it would reform and cut wasteful jobs in the FDA, not much has changed. The problem lies much deeper than the FDA itself and has little to do with who is in charge of it.
The Institutional Problem
As Milton and Rose Friedman observed in Free to Choose, the FDA could have the best people with the best of intentions, but it will still dampen innovation and block useful drugs. A proper solution would not be limited to simply reforming the FDA from within. Rather, it must also pursue a shift in the social and political institutions involved in the agency’s decision-making process.
To understand this, as the Friedmans suggested, you must put yourself in the shoes of an FDA official charged with the decision to approve or reject the commercialization of 7-OH. Two errors are possible. You might approve it, and it could turn out to be dangerous, creating a public-health disaster which puts your name in every headline. Or you might ban it, depriving patients of what could have been a life-saving alternative, but no one will ever know.
Arguably, if 7-OH is banned, the people who might have benefited from the product—those who relapse into opioids—will probably not complain. More importantly, if they die of an overdose, their families will probably never realize an excess of bureaucratic caution cost their loved ones’ lives. When choosing between potentially causing a national overdose crisis or going unnoticed, even the most dedicated civil servant risks skewing toward banning 7-OH.
Internal Reform Isn’t Enough
The FDA holds immense power over which products are approved or rejected. With great power comes great responsibility. This dynamic creates strong social and political pressures which inevitably shape the behavior of FDA officials, who tend to favor less risky decisions.
The DOGE agency was created to restructure the FDA, but it attempted only an internal reform. Instead, it needs a shift in the balance of power and responsibility, away from the FDA and closer to those who were the ultimate decision-makers before the agency even existed: American consumers. In essence, the FDA should serve as an information provider rather than a gatekeeper, warning consumers about potential risks while allowing them to make informed choices for themselves.
Such structural changes are neither easy nor quick, but they are far more sustainable. Regardless of the outcome of the FDA’s decision on 7-OH, these issues will continue to arise as long as the agency is regarded as the final authority on new drugs. Perhaps this time the public will take it as a wake-up call to stop delegating meaningful decisions to government bureaucrats and act as the free and responsible individuals they are.
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