The Blueprint for a Bigger Medical Bureaucracy, Part 3

This article concludes my assessment of Unleash Prosperity’s report on reforming the FDA. In Part 1, I argued that much of what the authors recommend would expand the agency’s power even as they try to reform it, a dangerous way to pursue speed. In Part 2, I criticized their push to extend Operation Warp Speed–style partnerships into other corners of public health.

Both parts were largely critical. But there is a great deal to praise here, and the report’s central instinct is right.

The problem isn’t that the FDA checks whether drugs are safe. It’s that the FDA also insists on proving they are effective before anyone can use them. That second demand came later. In its early years, the agency policed safety on its own. The efficacy requirement arrived only with the 1962 Kefauver-Harris Amendments, and as Daniel Klein has explained, it added years and enormous cost to approval without a clear payoff for patients.

The report is also right that off-label prescribing shows the way. Once the FDA approves a drug as safe, doctors can prescribe it for other uses for which it was never formally approved. This happens constantly. Alex Tabarrok has documented that most cancer patients receive at least one off-label drug, and that a majority of antidepressant use, 56 percent in one survey, is for conditions the FDA never approved.

The examples write themselves. Minoxidil was approved to lower blood pressure; when doctors noticed it also promoted hair growth, it became Rogaine. Viagra started life as a heart drug. As Tabarrok and I have both documented, the market keeps finding a drug’s best use long after the FDA has approved it for something else, and the agency has nothing to do with the discovery.

This is the deeper point the report gestures at but never quite says. The reason the FDA’s efficacy testing should shrink is that markets find effective uses faster and cheaper than any agency can. We saw it during COVID-19. When the FDA finally stepped back and used an “umbrella” approach to authorize privately developed tests, testing capacity expanded almost overnight. The bottleneck was never the science. It was the regulation.

Markets are also quicker to recognize what doesn’t work. Take the decongestant phenylephrine, found in Sudafed and dozens of other products. Studies showed it didn’t relieve congestion more than a decade before an FDA panel finally admitted the same. The agency began asking the question in 2008 and spent fifteen years reaching an answer that the evidence had already given.

The report’s call to expand right-to-try legislation is just as welcome. These laws let terminally ill patients try experimental treatments before the FDA signs off. But there’s a wrinkle worth noting. Federal right-to-try has underperformed. At the state level, it has been a tremendous success.

The idea started in the states, with people like Ted Harada. Diagnosed with ALS and told an experimental procedure wouldn’t help, he tried it anyway under Georgia’s right-to-try law. His symptoms reversed. Before treatment, he couldn’t open a Ziploc bag; afterward, he could hike and play with his children. 41 states passed their own right-to-try laws before Congress enacted a federal law in 2018.

Here again, the pattern holds. Local legislation, with less bureaucracy and fewer complications, proved better suited to real, potentially life-saving reform than the federal version that followed.

Some states haven’t stopped there. After right-to-try went federal, Arizona expanded its law to cover individualized, patient-specific treatments, a “Right to Try 2.0” that reaches beyond what Washington authorized. Colorado and more than a dozen other states have followed. The states are still innovating. The federal government passed one law and moved on.

A faster FDA will not come from a bigger FDA, a new federal office, or another Warp Speed. Unleash Prosperity has correctly diagnosed a real and costly problem, and some of its instincts, on efficacy, on off-label use, on right-to-try, point in exactly the right direction. My worry is the cure. Speed will come from letting markets, doctors, patients, and the states do what they already do well, and asking the agency to do less. That is the reform worth fighting for.