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COVID has given us a clear view of a broken food and drug administration entangled in politics and bureaucracy.

Americans can now see why medical advances often come at turtle pace. We need new leadership at the FDA to change the culture of the agency and promote, not hinder, scientific progress.

It starts at the top. Our public health executives are now also accepting the bureaucratic processes that would be outrageous to a fresh eye. For example, last week the antiviral pill molnupiravir was found to cut COVID hospital admissions in half and, notably, no one who took the drug died.

The irony is that molnupiravir was developed a year ago. Calculate how many lives would have been saved if health authorities had acted quickly and enabled ongoing studies to assess every infection and adverse event in real time. Instead, we have a process that is similar to a 7-part college application for each of the Phase 1, 2, and 3 clinical trials.

DR. MARTY MAKARY: I HAVE MEDICAL CONCERNS ABOUT BIDEN’S NEW VACCINE MANDATES

The FDA has now received molnupiravir’s application for an EUA, which the agency will be considering in the next two to three months. Approval for this life-saving drug is not expected until the last wave of Covid is over. We cannot use peace processes in a time of war.

For too long, FDA executives have acted like grumpy librarians who get annoyed when someone tries to borrow a book. But then give preference to the people who like them.

For example, why didn’t the FDA issue an emergency clearance for the Oxford / AstraZeneca vaccine? The UK approved it last year and more than a billion doses have been given worldwide. We desperately needed this life-saving vaccine when American seniors were dying by the thousands every day and we were rationing our limited supplies.

The FDA needs a culture change. The status quo is characterized by counterproductive rigidity and a refusal to adapt. For example, since the FDA first approved a COVID vaccine, a lot of data has shown that spacing the first two doses of a Covid vaccine by a few months or more leads to increased immunity – a principle that applies to any vaccine in the Medicine applies. In the case of the Pfizer vaccine, a three-month waiting period between the first and second dose results in a 3.5-fold immunity.

However, the FDA is absolutely of the opinion that people still need to get their second dose of mRNA 3 or 4 weeks after the first because that is how their committee voted for their approval first. The new data is clear, everyone should be encouraged to distribute their first two vaccine doses by months rather than weeks. This would likely eliminate the need for a booster in the future. It is absolutely baffling to me and many others that the FDA is still insisting that people show up 3 weeks after their first dose of Pfizer vaccine, even though we should urge people to come back after 3 months.

More of opinion

In 1995, despite sparse data supporting OxyContin as a chronic pain treatment, the FDA granted the drug full approval, thus helping spark the US opioid crisis. Ever wonder what happened to the FDA regulator that oversaw this approval? Now she runs the agency.

Dr. Janet Woodcock, a 35-year-old agency veteran, took over the helm in January, spearheading Johnson & Johnson’s extended vaccine hiatus, which canceled millions of vaccinations and fueled hesitation. Weeks later, her agency decided not to convene an advisory board when evaluating a COVID vaccine for children aged 12-15.

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

Failing to call up these experts was a convenient way to ignore concerns about heart infection from the second dose, which is estimated to affect up to 1 in 6,000 boys. Furthermore, the rigid FDA guidance would not consider a single dose of the vaccine for children or a changed interval between doses, even for those who had previously had Covid.

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Perhaps most troubling is that Dr. Woodcock signed a letter last month calling for a booster vaccination for most Americans from Sept. 20 before her agency’s assessment. It was unprecedented for the head of the nation’s leading drug agency to make such a statement, synchronized with a push by the White House.

The FDA’s head of vaccines resigned shortly thereafter, along with her deputy director, clearly in protest at the political intrusion. They went to the pages of a peer-reviewed magazine to detail that for most Americans the data just isn’t there to support boosters. It never was. Then, following a backlash from the medical community, Woodcock and the CDC director publicly warned the White House to withdraw from the “everyone gets boosters” plan.

In the end, the premature call for boosters distracted Americans from the critical message that vaccines save lives and has been deaf to calls for global vaccine justice as half the world lacks a vaccine. Additionally, Americans are puzzled by the FDA’s rejection of Pfizer boosters for the general public, while the CDC left the door wide open to everyone except perhaps a young skinny ranger who works alone.

The FDA has also fueled reservations about vaccines through its bureaucratic delays in approving vaccines. Despite an impeccable safety profile, it took until the end of August for the Pfizer vaccine to receive full regulatory approval. Ironically, it came after 363 million doses of Covid vaccine were administered in the US. The other vaccines are still awaiting full approval.

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I wouldn’t characterize drug approvals from the FDA as predictably slow. I would describe them as unpredictable. Led by Woodcock, the agency granted full and expedited approval for an Alzheimer’s drug several months ago with no data to show clinical benefit. In fact, the FDA’s external experts who examined the drug (abducanumab) voted unanimously (7-0) against the approval. Three resigned in protest when the agency ignored their instructions and approved them.

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

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Drs. Woodcock, 73, Francis Collins, 71, who recently announced his retirement, and Anthony Fauci, 80, have valuable wisdom, but they are all like-minded, such as the collective release of natural immunity. Additionally, they seem to be complacent with our broken health bureaucracies.

For example, any new leader would be angry to know that the NIH spent twice as much tax dollars on aging research as it did on COVID research in the past year. When the CDC closed public school children last year, they were all mothers.

It is time for our old medical leaders to step aside in advisory roles and for new scientists, who are not afraid to speak out, to take responsibility.

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