Makary Must Go

America is, without a doubt, the most innovative country in the world. Whether it’s lifesaving pharmaceuticals, groundbreaking artificial intelligence (AI) models, smartphones, or the internet on the whole, American entrepreneurs have led the way into the future. But the promise of U.S. innovation is only as good as its regulatory apparatus. And, while the Trump administration has laudably committed to regulatory reform across the government, there remains one troubling eyesore—the Food and Drug Administration (FDA).

Since assuming the role of Food and Drugs Commissioner last April, Dr. Marty Makary has made it far more difficult than it needs to be to bring new therapies to market. Millions of Americans have paid the price for this “soap opera” of suddenly spurned approvals, goalpost shifting, and even apparent violations of trade secret law. Commissioner Makary will try his best to explain himself at an upcoming Senate Appropriations Committee hearing, but it will be too little too late. It is time for Commissioner Makary to step aside.

By any measure, the FDA is approving medications even more slowly now than it did before Commissioner Makary took the helm. As the Taxpayers Protection Alliance (TPA) noted in its recent report “Blocking Breakthroughs: Delays and Denials at the FDA,” the FDA has become significantly more likely to issue a Complete Response Letter (CRL)—or rejection. Not only have rejections increased as a share of agency approval decisions; there was
a particularly sharp uptick from 2024 to 2025. TPA’s report notes that the FDA now denies nearly 30 percent of new drugs being considered, a figure near decade highs.

Despite rhetoric from Commissioner Makary that the agency is “cutting red tape” and “accelerating cures,” drug sponsors have expressed growing concern about surprise rejections even when medications seemed on track for approval.

Concerns about arbitrary regulatory outcomes are well-founded. As noted in a recent report by The Wall Street Journal’s Allysia Finley, “After receiving Replimune’s melanoma treatment, one-third of patients who hadn’t responded to other immunotherapies went into remission. A back-of-the-envelope calculation suggests that it could save 2,500 lives each year. Dr. Makary decided patients shouldn’t have the right to try the drug.”

In many cases, rejected drugs have already been approved in other developed nations. The FDA has repeatedly refused to greenlight an ophthalmic version of the already-approved Avastin for wet age-related macular degeneration. The agency (wrongly) claims that there isn’t enough evidence that the medication works, a contention that even notoriously risk-averse European regulators reject. But what’s good enough for German and United Kingdom patients apparently isn’t good enough for their transatlantic cousins.

Ditto for a higher dose formulation of Spinraza for the treatment of spinal muscular atrophy. According to a September report in Pharmaceutical Technology, “The agency chose to decline the antisense oligonucleotide’s (ASO) approval due to insufficient technical information listed under the chemistry, manufacturing and controls (CMC) section of its supplemental new drug application.” In other words, paperwork took precedence over a medication proven to be safe and effective. Never mind that the purportedly missing information is “readily available,” and Japanese consumers have ready access to the high dose Spinraza regimen. Finally, after months of significant public pressure, the FDA greenlit the regimen in late March.

Similarly, it took a barrage of pressure—most significantly from the White House—for Makary’s FDA to finally approve life-saving vaping products, which are 95 percent less harmful than cigarettes. It shouldn’t take this much work to get the FDA to do its job and allow access to safe and effective products.

Commissioner Makary should be promptly replaced with someone who values patient choice and won’t get in the way of game-changing therapies and products. America will continue to lead the way on innovation, but only with the right leadership.