Is FDA Commissioner Marty Makary Putting Politics Over Science? –

When FDA Commissioner Marty Makary unveiled his plan to overhaul how the agency reviews new drugs, it was hailed as a historic step to get treatments to patients faster. But now, his big idea—the National Priority Voucher program—is drawing serious heat from Congress, the medical community, and even FDA insiders, who all worry it’s more about politics than science.

So, how does it work? The program, which kicked off in June 2025, gives special “National Priority Vouchers” to companies making drugs for what the administration calls “U.S. national health priorities.” A voucher is basically a golden ticket for a super-fast FDA review, cutting the usual 10-to-12-month wait down to just a month or two. So far, 18 of these vouchers have gone to treatments for everything from cancer and sickle cell disease to obesity and infertility. The goal seems simple enough: accelerate the development of important new therapies and encourage drug companies to invest in neglected areas.

But critics are asking tough questions about how the program actually runs. The core of the backlash is that the process feels secretive, with decisions seemingly driven by political appointees rather than the FDA’s own scientists. It’s not just whispers, either. In a November 2025 letter, members of Congress pointed out that the program was never approved by law and warned it could become a “lucrative gift for drugmakers and allies politically favored by the administration,” opening the door to favoritism or even corruption.

And it isn’t just Congress. Independent experts and FDA staff are also sounding the alarm. According to STAT reporting, top officials have been heavily involved at every step of the voucher process, sometimes overriding the concerns of career reviewers and even pushing for certain companies to receive vouchers as part of backroom political deals.

The tension is palpable inside the FDA as well. Some of the agency’s own career scientists are reportedly concerned that the breakneck pace of these reviews—making a call in weeks rather than months—could compromise their rigorous standards. In one case, a drug review team was allegedly excluded from a key vote, with senior leaders taking over in a highly unusual “tumor board”- style meeting. Normally, the scientists who know the data inside and out make that call—a firewall meant to keep the science pure.

This conflict extends to the top. Richard Pazdur, the respected head of the FDA’s drug center, has reportedly clashed with Makary, raising concerns that the program is secretive, potentially illegal, and sidelines his own scientists.

In addition to internal turmoil, the program faces significant legal and practical hurdles. Because it was created by the Commissioner’s office—not through law or a formal rulemaking process—legal experts believe it’s vulnerable to lawsuits. There are also day-to-day problems. Rushing these reviews means diverting experienced scientists from other important work, potentially straining the entire system. To make matters worse, Makary has added controversial new criteria for obtaining a voucher, such as drug pricing and domestic manufacturing—factors the FDA has never been allowed to consider when evaluating a drug’s safety and effectiveness.

This whole voucher controversy isn’t happening in a vacuum. It comes during a period of major upheaval at the FDA, with senior leaders leaving and widespread anxiety about the agency’s independence. For an institution whose reputation is built on objective science, the perception that politics are creeping into the review process is deeply damaging.

Makary’s program was designed to be a bold solution to deliver critical medicines to people in need. But with its murky rules and heavy-handed political involvement, it’s raising more questions than it answers. As Congress demands accountability and insiders warn that the science is being compromised, the fundamental question is stark: can the FDA speed things up without breaking the very system of trust it was built to protect?

I’m Richard Meyer — a healthcare marketing strategist and writer focused on the intersection of direct-to-consumer marketing, healthcare economics, and human behavior.I started Work of DTC Marketing because too much of the conversation around pharma and healthcare marketing is either overly promotional, overly technical, or completely disconnected from how the system actually works.Here, I write about what DTC really does, how incentives drive behavior inside healthcare organizations, why patients are often treated like revenue streams instead of people, and why “best practices” are frequently just recycled assumptions.My background spans digital marketing, public relations, and healthcare strategy, and my approach is pragmatic, skeptical of hype, and grounded in data and lived experience. I’m less interested in what sounds good in a deck and more interested in what actually changes outcomes — for companies, doctors, and especially patients.