COVID-19

The COVID Reckoning Doesn't Go Far Enough

Real medical freedom will require something greater than replacing the public health establishment: ending the FDA's monopoly.

Zach Weissmueller | 4.21.2026 10:45 AM

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The public health establishment lost America's trust during the COVID-19 pandemic with its bureaucratic incompetence, "noble lies," and authoritarian mandates. 

It was about time. Agencies like the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) have been failing the American public for decades. But the agency with the worst track record is the Food and Drug Administration (FDA), which, long before COVID, caused Americans to lose hundreds of thousands of life years by slowing down drug development. After COVID, the American public had finally started to catch on.

President Donald Trump put a new team in charge of the federal health apparatus, some of them truth-telling contrarians who risked their careers to expose the sins of the old guard. But it's also a messy picture because the man in charge of Health and Human Services has controversial theories about the dangers of vaccination with little factual basis.

So where does that leave things? Is the public health apparatus finally being upended? Or are the inmates running the asylum?

Nobody, no matter their integrity or political persuasion, should have the power to decide what you or I put in our bodies. The only way to fix America's regulatory health care apparatus is to dismantle it. A new guard has replaced the old. The COVID reckoning is here. But it hasn't gone far enough.

The FDA Power Play

The story of an overreaching public health state doesn't begin with Robert F. Kennedy Jr. or Dr. Anthony Fauci. It begins with a law passed in 1962.

The FDA didn't always throw up as much red tape as it does today. In its early days, its only job was to sign off on safety. Drug makers would submit safety evidence, and if the agency didn't object within 60 days, the drug could go to market and be sold right over the counter. Back then, it was the drug company that decided whether to require a doctor's prescription or not based on liability concerns.

This voluntary arrangement between drug manufacturers, patients, and doctors worked fairly well, says Jeffrey Singer, a practicing surgeon and senior fellow in the Department of Health Policy Studies at the Cato Institute. 

"If [the drug manufacturer] thought that their drug was a little too risky and some people could have problems and they'll get sued, they would say to the pharmacist, we only want our product to be sold to people who have a prescription," he says.

It was a system based on informed consent and voluntary exchange.

But federal control over pharmaceuticals started expanding in 1951, when Congress passed the Durham-Humphrey Amendment, which limited which drugs could be sold over the counter and empowered the FDA to enforce the rule.

That was just the beginning. About a decade later, a sedative called thalidomide was on the market in Europe to help pregnant women alleviate their nausea. The drug turned out to cause severe birth defects. Many fetuses died in utero or shortly after birth.

FDA medical officer Frances Kelsey had blocked thalidomide's approval in the U.S., earning her the President's Award for Distinguished Federal Civilian Service.

Congress reacted by passing a new law that vastly increased the FDA's power. The Kefauver-Harris Amendments empowered the agency to hold drugs off the market until it deemed them not only safe but also effective.

Why did thalidomide lead to this vast expansion of FDA power? After all, thalidomide was quite effective, just not at all safe for pregnant mothers. The FDA already had the power to regulate drugs on safety grounds. What happened is that the thalidomide episode created a new political reality, with federal health regulators like Kelsey cast as benevolent guardians of our health and well-being.

The Kefauver Amendment, which had been languishing in Congress, suddenly had broad support. Scientists would have to use randomized controlled trials to ensure that pharmaceuticals do what they say they do.

That all sounds reasonable. But, in practice, the law had some catastrophic unintended consequences.

Roadblocks to Medical Progress

In the 1960s, healthcare was primitive by today's standards, but as drug innovation accelerated, the FDA became a major bottleneck in the development process, with regulatory compliance adding billions to the cost of bringing new drugs to market.

One researcher coined the phrase "Eroom's Law" to describe the dramatically falling return on investment for pharma research over time—a backwards spelling of Moore's Law that describes the exponentially improving efficiency of computing power.

The time it takes to move a drug from discovery to sale increased from eight years in 1960 to between 12 and 15 years by 2010. Research and development costs exploded from about $100 million per drug in 1975 to $1.3 billion by 2005. Pharmaceutical innovation stagnated.

The political incentive problem the FDA faces is that the public is outraged when a harmful drug slips through but tends not to notice when a life-saving drug is blocked.

The economist Milton Friedman described this phenomenon in a 1999 interview with the Hoover Institution. "The pressure on the FDA is always to be late in approving," Friedman said, "and there is enormous evidence that they have caused more deaths by their late approvals than they have saved by their........

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