The Blueprint for a Bigger Medical Bureaucracy

A new report from Unleash Prosperity, a free-market policy group, makes a bold and welcome claim: reforming the FDA could unlock trillions of dollars. The authors’ biggest target isn’t safety testing. It’s the years the FDA spends proving a drug actually works. Trim one year off that process, they estimate, and we generate more than $10 trillion in value to patients and producers. Trim six years, and the figure climbs past $60 trillion.

That diagnosis, laid out in The Multi-Trillion Dollar Opportunity in Reforming the FDA, is hard to argue with. It takes roughly a decade for a new drug to clear the agency. Most of that time isn’t spent proving the drug is safe. It’s spent proving it works. Developing one now costs nearly $880 million on average, closer to $1.2 billion for cancer and eye treatments, and about 90 percent of trials fail. Meanwhile, the report notes, China has cut its lab-to-trial timelines by 50 to 70 percent and runs clinical trials 50 to 60 percent cheaper than we do.

The paper is clear, concise, and convincing in its presentation of the problem. The proposal is where it goes wrong. I believe it will cause more harm than good if enacted, and I’m writing a three-part series to explain why. In this first part, I’ll start with an irony. For all its deregulatory language, the plan would leave the FDA bigger than it is today: with more authority, more staff and greater reach.

So what does the report recommend? Reform, of course. And by “reform,” the authors mostly mean giving the FDA more to do. They call on policymakers to “establish a Cancer Warp Speed Office” with “line-of-sight to FDA, NIH, NCI, CMS, and DoD/VA, led by a director reporting to the President, HHS Secretary, and the FDA Commissioner.”

They want the Prescription Drug User Fee Act to fund “a dedicated hiring commitment” for the agency’s oncology, gene-therapy, and rare-disease review teams. They call for its “Title 42 authority for specialized scientific and medical officers” to be “expanded.” They want the Project Orbis review to be “extended beyond oncology products to all serious and life-threatening conditions.” And throughout, they lean on artificial intelligence: more AI to approve drugs, and more AI to watch them afterward.

Read that list again. A new federal office. A dedicated hiring commitment. Expanded statutory authority. A review program stretched across every serious disease. These aren’t the marks of a smaller, faster FDA. They’re the blueprint for a bigger one. The report would deregulate the drug market by expanding the very agency that regulates it.

The FDA has already shown what happens when we ask it to innovate for us. Take nicotine. For years, the agency tried to bring better smoking-cessation products to market. After four years of promotion, revised standards, and public feedback, it approved just three nicotine replacement therapies, each one dependent on additional behavioral interventions to work.

A better solution was sitting in plain sight the whole time. E-cigarettes are cheaper, more reliable, and endorsed as a cessation aid by Harvard Health and the United Kingdom’s National Health Service. The FDA didn’t need a bigger budget to find a better answer.

The report’s faith in artificial intelligence deserves the same skepticism. We’ve watched HHS try this already. The FDA launched an AI assistant named Elsa to help review clinical protocols. Employees quickly found it “was making stuff up,” hallucinating and mischaracterizing findings from clinical trials.

Weeks earlier, an HHS report was caught citing nonexistent studies and at least 21 dead links, likely because someone leaned on ChatGPT to write it. The problem was never AI itself. It’s that the agency keeps reaching for tools it isn’t ready to use. Handing it to more of them won’t fix that.

The report also assumes the FDA can simply hire and keep the right people. History suggests otherwise. FDA commissioners rarely last. Across his two terms, President Trump has now cycled through four: Scott Gottlieb, Stephen Hahn, Robert Califf, and Marty Makary.

Makary resigned in May 2026 after just thirteen months. His acting replacement, Kyle Diamantas, is a lawyer, not a physician. Under Secretary Robert F. Kennedy Jr., turnover has been constant and real reform has been elusive. A “dedicated hiring commitment” is only as good as the agency’s ability to keep the people it hires.

Finally, the report wants the FDA to branch into new territory. New offices. New detection frameworks. New mandates spanning cancer, neurodegeneration, and infectious disease. But every time the agency expands its reach, the story ends the same way. Its six-year war on vaping is the clearest example.

The FDA raided Juul’s headquarters, fined more than 1,300 retailers, banned flavored products, and ran industry leaders out of the market. Teen vaping rates barely moved. The CDC itself credits the eventual decline to price increases and public-awareness campaigns, not agency raids. That war may finally be ending. But only after years of chaos, with no measurable benefit.

Reforms are surely needed. But it’s hard to imagine how these, many of them tried under other names in recent years, could shorten approval times or spread medical innovation. The common thread among them is a larger, busier, more powerful FDA- none of which makes it faster.

Perhaps more concerning is the proposal’s frequent reliance on Operation Warp Speed, the public-private partnership that brought the COVID-19 vaccines to market in late 2020, as the template for fixing other corners of American public health.

While seemingly plausible, the devil is in the details again. I’ll explain why in Part 2.