Dr. Marty Makary: The FDA needs new leadership

The FDA urgently needs a change in culture

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COVID has given us a clear-eyed look at a broken Food and Drug Administration that’s mired in politics and red tape. 

Americans can now see why medical advances often move at turtle speed. We need fresh leadership at the FDA to change the culture at the agency and promote scientific advancement, not hinder it.

This starts at the top. Our public health leaders have become too be accepting of the bureaucratic processes that would outrage a fresh eye. For example, last week the antiviral pill Molnupiravir was found to cut COVID hospitalizations in half and, remarkably, no one who got the drug died. 

The irony is that Molnupiravir was developed a year ago. Do the math on the number of lives that could have been saved if health officials would have moved fast, allowing rolling trials with an evaluation of each infection and adverse event in real-time. Instead, we have a process that resembles a 7-part college application for each of the phase 1, 2, and 3 clinical trials. 

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The FDA is now in receipt of Molnupiravir’ application for an EUA, which the agency will ponder for the next two to three months. Authorization of this life-saving drug is expected just when the last Covid wave will be over. We can’t use peacetime processes in a time of war.

For too long, FDA leaders have acted like a crusty librarian who gets annoyed when someone wants to borrow a book. But then give preference to people they like. 

For example, why hasn’t the FDA granted an emergency use authorization for the Oxford/AstraZeneca vaccine? The U.K. approved it last year and more than a billion doses have been delivered worldwide. We badly needed that life-saving vaccine back when American seniors were dying by the thousands each day and we were rationing our limited supply.

The FDA needs a change in culture. The status quo is defined by counterproductive rigidity and a refusal to adapt. For example, since the FDA first authorized a COVID vaccine, ample data has demonstrated that spacing out the first two doses of a Covid vaccine by a few months or more generates stronger immunity—a principle that’s true for any vaccine in medicine. In the case of the Pfizer vaccine, waiting three months between the first and second dose results in 3.5-times the immunity.

Yet the FDA is absolute that people still must get their second mRNA dose at 3 or 4 weeks after the first because that’s how its committee first voted to authorize them. The new data are clear, everyone should be encouraged to space out their first two vaccine doses by months instead of weeks. Doing so would likely obviate the need for a booster in the future. It’s absolutely mind boggling to me and many others that the FDA still insists that people show up 3 weeks after their first Pfizer vaccine dose when we should be urging people to come back at 3 months.

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Dr. Janet Woodcock, an agency veteran of 35 years, took the helm in January and presided over the prolonged Johnson & Johnson vaccine pause that cancelled millions of vaccinations and fueled hesitancy. Weeks later, her agency decided to not convene its expert advisory committee when evaluating a COVID vaccine for children 12 to 15. 

Diversity in the leadership of any organization is important because different life experiences can help solve problems and challenge a status quo. But our top FDA and NIH leadership lack minority and age diversity.

Not convening these experts was a convenient way to ignore concern about heart inflammation from the second dose, which is estimated to occur in up to 1 in 6,000 boys. Moreover, the rigid FDA leadership would not consider a single dose of the vaccine for kids, or a modified interval between doses, even in those who had previously had Covid.

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Perhaps most disturbing, Dr. Woodcock signed a letter last month calling for booster shots for most Americans starting September 20, ahead of her agency’s evaluation. For the head of the nation’s top drug regulatory agency to issue such a statement, synchronized with a White House push, was unprecedented. 

The FDA’s head of vaccines resigned soon after, along with her deputy director, clearly in protest of the intrusion of politics. They took to the pages of a peer-reviewed journal to detail how the data is simply not there to support boosters for most Americans. It never was. Then after backlash from the medical community, Woodcock and the CDC director publicly warned the White House to back away from the "everyone get boosters" plan. 

In the end, the premature call for boosters distracted Americans from the critical message that vaccines save lives and was tone deaf to calls for global vaccine equity as half the world has no vaccine. Moreover, Americans are confused about the FDA's down vote on Pfizer boosters for the general public while the CDC left the door wide open everyone except for perhaps a young thin forest ranger who works alone.

The FDA also fueled vaccine hesitancy through its bureaucratic delays in approving vaccines. Despite an impeccable safety profile, it took until late August for the Pfizer vaccine to be granted full approval by the agency. Ironically, it came after 363 million Covid vaccine doses were administered in the U.S. The other vaccines still await full approval.

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I would not characterize drug approvals coming from the FDA as predictably slow. I would describe them as erratic. Under Woodcock’s leadership a few months ago, the agency granted a full and accelerated approval for an Alzheimer’s drug with zero data to show a clinical benefit. In fact, the FDA’s external experts examining the drug (Abducanumab) voted unanimously (7-0) against approval. Three resigned in protest when the agency ignored their guidance and approved it.

Diversity in the leadership of any organization is important because different life experiences can help solve problems and challenge a status quo. But our top FDA and NIH leadership lack minority and age diversity.

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Drs. Woodcock (age 73), Francis Collins (age 71) who recently announced his retirement, and Anthony Fauci (age 80) have valuable wisdom but they are all like-minded, such as in their collective dismissal of natural immunity. Moreover, they seem complacent with our broken health bureaucracies. 

For example, any new leader would be irate to know that the NIH spent twice as much taxpayer money on aging research last year than it did on COVID research. Last year, when the CDC shut children out of public schools, they were all mum. 

It’s time for our old guard medical leaders to step aside into advisory roles and let new scientists, ones who are not afraid to speak up, take charge.

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