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The FDA's slow road to full vaccine approval shouldn't surprise anyone

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WASHINGTON — Warren Buffett famously remarked that “Only when the tide goes out do you discover who’s been swimming naked.” Of course, Buffett was talking about his industry — the quacks and frauds who surf the surging boom market, only to get beached when the waves of easy money recede. But his adage could easily be applied to the Food and Drug Administration and the Centers for Disease Control and Prevention, whose bureaucratic procedures looked fine right up to the point when the pandemic showed them to be disastrous.

By now, most people paying attention to the agencies seem to have conceded there is something very wrong with the CDC — recall the early coronavirus testing debacles, its slowness in embracing masks or acknowledging airborne transmission, the apparent politicization of guidance surrounding schools, the decision to stop tracking breakthrough Covid cases, the inability to provide real-time data on infections.

Yet, in the long run, the FDA issues are probably more consequential. While we don’t expect a pandemic to hit every year, most of us might eventually get some life-threatening illness that we’d really rather cure. And the Covid-19 pandemic has made clear how FDA procedure can hamper the United States’ progress in the fight against disease.

It isn’t just the way the FDA helped exacerbate the CDC’s testing problems early on. The agency has also been slow on approving vaccines — perhaps only by a matter of weeks but, in this pandemic, weeks kill. The Pfizer-BioNTech vaccine finally got full approval this week, though some had been calling for it since early July. In early August, the American Academy of Pediatrics urged the FDA to speed up trials of vaccines in younger children, to little apparent effect.

On Tuesday, David Leonhardt of the New York Times pointed out that FDA officials have been urging people to get vaccinated against Covid at the same time the agency insisted further review was needed before it moved beyond emergency authorization.

“The wait for full approval, then, was more about process than science,” Leonhardt writes.

He concludes: “During normal times, taking the cautious route and following procedural precedent tends to make sense. It minimizes chaos and mistakes.”

“But a national emergency can change the equation.”

This is a persuasive argument, as far as it goes — but shouldn’t it go further? Any life-threatening condition is an emergency for the people who have it. They will be no less dead if they die waiting for a treatment for cancer or heart disease that has gotten bogged down in FDA review.

But as economist Milton Friedman pointed out in 1973, FDA incentives inevitably tend toward the risk-averse in ordinary times. If regulators approve a drug that turns out to be unsafe, there will be endless blowback, while if they refuse to approve one that actually works, most people will never know about it. For that matter, the FDA recently took quite a lot of flack over approving Aduhelm, an Alzheimer’s drug that doesn’t seem particularly unsafe and doesn’t seem to help much either.

As we can now plainly see, those incentives have helped shape a too-cautious culture. Not that FDA officials are necessarily deliberately slowing things to protect themselves; rather, they probably think they are husbanding institutional credibility for altruistic reasons. After all, FDA certification of drugs as safe and effective would do the public little good if no one trusts it.

Yet this sort of pop-psychologizing wouldn’t pass the rigorous cost-benefit test that the FDA imposes on pharmaceuticals. Most people are not avid FDA watchers, masters of the minutiae of bureaucratic process. Most adults, in fact, had already gotten vaccinated before the Pfizer vaccine was fully approved. For some people, adding extra months of scrutiny before full approval may make a difference — but are those people more or less numerous than the folks who died in the interim, while businesses and government agencies were waiting for that approval in order to implement their vaccine mandates?

It would be better if our public health agencies stopped trying to manipulate public perceptions and focused on giving us the truth as expeditiously as possible. And the truth is, the FDA believed in the safety and efficacy of the coronavirus vaccine months ago. It should have said so the clearest way possible, as quickly as possible: with an official approval.

But we can’t expect the FDA to adopt that kind of thinking only for emergencies. Saying you want the FDA mostly as it is, except that it should behave differently in a pandemic is, in Friedman’s words, like saying “I would like to have a cat, provided it barked.” An agency with a mandate to be ultra fussy about procedure will have an institutional culture that supports such fussiness, and personnel who thrive in that kind of environment. When the emergency comes, that agency will be ill-equipped for a sudden switch to high-speed lifeboat ethics.

If we want an FDA that actually can perform as fast as possible during a pandemic, when American lives are on the line, then we should remember that American lives have always hinged on FDA decisions, and build an agency that acts accordingly every day of every year.

Distributed by The Washington Post Writers Group.

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