The Blueprint for a Bigger Medical Bureaucracy, Part 2

In Part 1 of my analysis of Unleash Prosperity’s report on reforming the FDA, I took a critical look at the authors’ many calls to expand the agency’s role and payroll while, in the same breath, demanding it move faster. The two goals sit uneasily together.

Now I turn to a different idea running through the report: a “warp speed” push aimed at the nation’s biggest public health threats. The use of the term clearly applies to Operation Warp Speed, the public-private partnership President Trump launched in May 2020, pairing a handful of vaccine developers with federal agencies and a near blank check of federal money. By December, we had both vaccines.

The report wants to run that play again. It calls on the White House to establish a “Cancer Warp Speed Office” with a ten-year authorization and “line-of-sight to FDA, NIH, NCI, CMS, and DoD/VA.” The office would run regulatory review, manufacturing, and insurance-coverage decisions all at once, and hand out “advance market commitments and prize mechanisms” for cures to specific cancers. The report’s lead author has been blunter still, telling Fox News the president should “push an analogous effort to what he did with Operation Warp Speed during COVID.”

Operation Warp Speed did bring two COVID-19 vaccines to market. That is a real accomplishment. But before we make it the template for every hard problem in public health, two questions are worth asking. Did Warp Speed actually cause the result we credit it for? And what did it cost us after the cameras left?

Plenty of evidence suggests the vaccines would have arrived without it. Pfizer, which developed the first authorized vaccine, purposefully used its own laboratories and equipment instead of those OWS provided, and refused to use its designated distributor. The roughly $2 billion in federal money Pfizer accepted was less than 10 percent of its average annual research budget. Moderna’s vaccine was fully developed on January 13, 2020, about a week before COVID-19 reached the United States. We had the vaccine the entire time. AstraZeneca, which failed to become a Warp Speed finalist, was vaccinating patients in the UK by early January. More than 100 other COVID-19 vaccines were in development while the program ran, many of them privately funded.

What happened during the pandemic tends to overshadow what might have happened under different rules. But the record shows private efforts have brought pioneering medicine to market in record time before, without a federal command center.

Take the Asian flu of 1957–58. It infected some 20 million Americans and killed around 116,000. At the time, the FDA didn’t regulate vaccines at all. Scientists developed one before the virus reached the country, and public and private agencies distributed 60 million doses in the first two months. As a report from that era put it, there was “no serious disruption of community life.”

It happened again in between, too. Many forget that government and private industry teamed up on another rushed vaccine long before Warp Speed. That one is a warning, not a model.

In 1976, the Ford administration launched the National Swine Flu Immunization Program. It pushed a vaccine to the public ahead of the FDA’s normal process, aiming to immunize 210 million Americans. About 40 million got the shot. Then came hundreds of cases of Guillain-Barré syndrome, a paralyzing nerve disorder, and dozens of deaths. The pandemic never arrived.

That is the part these proposals tend to skip. As my coauthor and I have argued, public-private partnerships built for a crisis are expensive, in dollars and in something harder to undo. Warp Speed was no exception.

Consider the money first. Warp Speed pledged roughly $10 billion in federal funds, dwarfing the NIH’s entire vaccine budget of about $900 million a year over the previous two decades. But the more lasting cost was power. The partnership handed HHS sole authority to set vaccine standards. In September 2020, the department rescinded the rulemaking authority it had delegated to its sub-agencies, including the FDA. Scott Gottlieb, Trump’s own former FDA chief, called it “exactly the wrong message.”

This is what economists call a ratchet. A crisis lets government expand fast. When the crisis passes, it rarely shrinks back. Warp Speed followed the script. Federal spending on COVID-19 vaccines topped $30 billion by early 2023, even as barely 16 percent of adults kept up with boosters. When monkeypox appeared in 2022, a far milder threat, the government reached for the same playbook of centralized distribution and national stockpiles.

The authority built during Warp Speed didn’t disappear when the pandemic did. It waited. It is the same consolidated power Robert F. Kennedy Jr. now uses to reshape vaccine policy at HHS, an irony worth sitting with, given how loudly he has criticized the program that handed it to him. A tool built to speed medicine to market can just as easily be used to slow it down.

My comments so far have been largely critical. But I think Unleash Prosperity’s research has real merit and a message worth taking seriously. In Part 3, I’ll close the series with the reforms I agree with, the ones that give all of us legitimate hope for a swifter, more effective FDA.