Makary’s FDA leadership raises alarms with ideology replacing sound medical judgment

OPINION:

Veteran conservative activist Morton Blackwell likes to remind people that “personnel is policy.”

He is right, and it’s something that people in the public eye should realize — like President Trump, who somehow doesn’t seem to understand how badly he is being served by his appointees inside the U.S. Food and Drug Administration.

By now, we are used to hearing the odd utterance from Health and Human Services Secretary Robert F. Kennedy Jr. His thinking about matters under his purview is, to be blunt, something far from orthodox. Yet when the head of the FDA tells a conference he would be reluctant to give his child antibiotics “unless he is on his deathbed or suffering,” things have gone past the sublime and the ridiculous.

Yet that is what FDA Commissioner Marty Makary told the recent attendees at the HHS National Conference on Women’s Health. Pediatric infectious disease experts immediately pushed back, warning that waiting until a child is “suffering” or “on their deathbed” at the very least stretches beyond breaking the limits on what should be considered responsible care. Parents don’t need a culture warrior telling them to do nothing more than apply a warm compress to a child suffering from an ear infection. They need an advocate for the health of their children whose only fear is that they are not doing enough to improve health care and approve new cures.

The country’s top regulator of the pharmaceutical industry should at least be dispassionate in his public pronouncements about entire categories of cures that keep people alive and healthy. His apparent skepticism is as unhealthy as some of the diseases antibiotics have knocked out for years.

Some conservatives have spent years warning that public health leaders were substituting ideology for evidence. Dr. Makary has just helped them prove the point. Antibiotic stewardship is important, but that was not what he was doing. He was posturing. He used a national platform to brag about how extreme he is willing to be, inviting further confusion among parents who have been whipsawed by a health care industrial complex that failed badly to get it right when it shuttered the schools during the COVID-19 emergency.

Dr. Makary’s observation didn’t emerge from a vacuum. His agency is poorly staffed, and it has been since the beginning of Mr. Trump’s second term. Dr. Vinay Prasad, now a twice-over senior staffer who once headed the critical FDA Center for Biologics Evaluation and Research, didn’t just wander into an open office at HHS to mount his anti-science campaign against lifesaving drugs. Dr. Makary recruited him, defended him and applauded his “reforms” even as rare disease patients, vaccine experts and industry saw chaos and uncertainty.

Markets and hopes rose on news that Dr. Prasad was returning to the private sector once again. That tells us a lot about how his leadership was viewed by those who invest in developing new lifesaving techniques and products.

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The people around Mr. Kennedy want us to believe that with Dr. Prasad gone once again, all the problems are solved. Far from it. His allies are still in powerful roles, most notably Dr. Makary, who thought he was the right man for the job and is still running the show. The same instincts that produced this mess are still driving major decisions.

The FDA is not a podcast. It is not a campus debate club. It is a serious agency with a mission that involves matters of life and death. It determines which drugs reach the market and which do not. It underpins the confidence we all have, or had, in the vaccines, cancer therapies and antibiotics that, in many cases, keep us alive. When Dr. Makary uses his office to sling provocative personal anecdotes about his own child’s care, he chips away at the credibility conservatives have rightly suggested was badly eroded by the many missteps the government made during the COVID-19 pandemic emergency.