FDA chief’s ouster is a good thing

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The Washington rumormongers were right. On way or another, Martin Makary, the administrator of the U.S. Food and Drug Administration, was on his way out.

It was about time.

Maklary was a disaster, but was far from single-handedly keeping Trump and U.S. Secretary of Health and Human Services Robert F. Kennedy, Jr., from accomplishing anything major. He and the team he assembled stood in the way of enacting the Making America Healthy Again initiatives that played a significant role in the 2024 election by winning over the votes of suburban Moms and younger people.

Under Makary, FDA bureaucrats routinely blocked the president from delivering on his agenda to make America healthier. Millions of patients were left without access to necessary care as the current system incentivized delays instead of action.

Many patients don’t have time to wait, which is why President Trump is following through on his mandate to improve healthcare. He’s slashed key drug prices, not always in a market friendly way. He and Secretary Kennedy have eliminated cost hiking regulations that don’t improve the quality of services.

The MAHA movement speaks for millions of Americans who think the healthcare complex profits off their suffering. Makary’s FDA stood in the way of reform, its bureaucrats running out the clock.

President Trump likes to talk about The Right to Try Act, a signature achievement of his first term that lets the terminally ill try, in consultation with their doctor, experimental treatments that had not yet received FDA approval,

That’s a profound statement about the power of personal choice the FDA has neutered at almost every turn. Patients are still begging for what by law they should have. Approvals are denied as the FDA, relying on regulatory excuses, fails to act. Drug rejections are up by 50%, application review deadlines are missed three times as many times as they were while approvals dropped 14%.

The approval pipeline has been clogged with bureaucratic gobbledygook. The competitive edge in biotech the U.S. has established is being dulled from the inside out, a point U.S. biotech CEOs made in late 2025 when they sent Makary a blistering letter documenting his agency’s failings. They outline a litany of missed approval deadlines, canceled advisory committee meetings, cancelled discussions with drug developers, and a take-it-or-leave-it posture that shut companies out.

For the smaller firms and innovators, these problems often cannot be overcome. That means promising treatments may never be developed because of bureaucratic resistance or, worse, inertia. Patients wait in the meantime for relief that many never come.

Dr. Scott Gottlieb, once the head of the FDA himself, warns the “ongoing assault on that drug-development enterprise threatens to quickly reinstate frustrating delays for American consumers, particularly impacting rare diseases and areas with significant unmet medical needs.”

Gottlieb’s right. The problems he forecast have arrived. China is closing the gap in biotech development. Biotechnology Innovation Organization CEO John Crowley told the U.S. Senate Beijing might surpass the U.S. within a couple of years, And, as one bipartisan commission put it, “Without immediate and bold action, the US will cede its dominance in biotech to China.”

China’s national biotech strategic priority is forward thinking and has allocated more biotech R&D space than in all of Boston. Nearly 30% of all global clinical trials are now there, compared to 35% in America. We can hear the footsteps coming up behind us quickly.

The Center for Strategic and International Studies warned in April 2026 that “the more immediate risk stems from domestic policy choices that could alter the incentives underpinning the U.S. innovation system.” Makary’s bureaucratic paralysis put us on a pathway to disaster. The new leadership must consist of outsiders with new paradigm for how the FDA is to maintain and enhance America’s global biotech leadership.

The American people gave Trump and Kennedy a mandate for significant change. The FDA should be led by people who recognize its existing corporate culture is probably the only thing preventing more saved lives and improved cures from happening.

The Biden people are no longer in charge. Without Makary in the way, Trump has a chance to stamp MAHA across the American heartland.

Copyright 2026 Peter Roff distributed by Cagle Cartoons newspaper syndicate.

Peter Roff is former U.S. News and World Report contributing editor and UPI senior political writer now affiliated with several DC-based public policy organizations. He writes for numerous publications and appears regularly on international television talking about U.S. politics. You can reach him at [email protected] and follow him on Twitter @TheRoffDraft.

About Peter Roff
Peter Roff is a media fellow at the Trans-Atlantic Leadership Network, a former columnist for U.S. News and World Report, and senior political writer for United Press International. Contact Roff at [email protected].
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