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U.S. Food and Drug Administration (FDA) Commissioner Marty Makary holds up a study from The Lancet during an announcement of the FDA’s intent to phase out the use of petroleum-based synthetic dyes in the nation’s food supply during a press conference at the Department of Health and Human Services in Washington, D.C., U.S., April 22, 2025. REUTERS/Elizabeth Frantz
Elizabeth Frantz | Reuters
A version of this article first appeared in CNBC’s Healthy Returns newsletter, which brings the latest health-care news straight to your inbox. Subscribe here to receive future editions.
This week, I had a chance to sit down with Food and Drug Administration Commissioner Dr. Marty Makary during a trip to Washington, D.C.
Our conversation came in the midst of a contentious stretch for the FDA, defined by a leadership transition, massive staff and budget cuts and sweeping changes to vaccine policy and the agency’s drug approval approach. Most recently, its back-and-forth on Moderna’s flu shot has fueled industry concern about regulatory consistency.
Here’s what Makary had to say on some of the topics top of mind for the pharmaceutical industry.
Watch my interview with Makary here.
Mass compounded GLP-1s
Makary said the FDA is “serious” about cracking down on unlawful, mass compounding of GLP-1s.
This comes on the heels of the FDA announcing plans to take action against telehealth company Hims & Hers, which has been mass marketing compounded versions of Novo Nordisk‘s Wegovy pill and injections.
The FDA said it plans to restrict GLP-1 ingredients used in non-approved compounded drugs, citing concerns over quality, safety and potential violations of federal law.
Makary said branded drug manufacturers go through the FDA process “properly” by conducting clinical trials that demonstrate the benefit of a product. The agency also regulates the marketing claims for those drugs, such as requiring that ads reflect side effects.
But Makary said, “Sometimes, what we’ve seen are companies that are violating those regulations.” The FDA is “directly talking to these companies and saying, you have to play by the rules,” he added.
When asked if 2026 could be the end of illegal mass compounding of GLP-1s, Makary said, “I hope so.” The FDA is seeing more companies get their active pharmaceutical ingredients from Novo Nordisk and Eli Lilly, “and that system has a path of working.”
“If [Novo and Lilly] are providing APIs and the compounding meets the regulation, then the more competition, the better,” he said.
Moderna’s flu shot application
Notably, my conversation with Makary came one day before the FDA agreed to review Moderna’s experimental mRNA flu shot, reversing the agency’s earlier decision to refuse to accept the application. The FDA is now slated to decide whether to approve the flu shot on Aug. 5.
Makary did not indicate that the agency would change its decision. Instead, he said the FDA’s guidance to Moderna on its jab “was pretty clear.”
“I think the FDA individual guidance process, when the companies meet with the FDA scientists, is pretty strong, and that guidance is pretty clear on how they want the trials designed,” he said.
The agency recommended that the group of participants ages 65 and up in the study who didn’t take Moderna’s shot receive the “standard of care, not the substandard of care” as a comparison product, Makary said. The FDA’s previous feedback expressed a preference for Moderna to use a higher-dose vaccine for older adults as a comparator in the trial.
Moderna has disputed that reasoning, noting that FDA rules and guidance does not actually require trials to use the most advanced or highest-dose vaccine as a comparator in clinical studies. The company has also said it is inconsistent with the FDA’s prior written communication about the trial design, even before the study began, where the agency said using the standard flu shot would be “acceptable.”
When asked about his stance on mRNA technology, Makary said he’s “hopeful and optimistic” about the platform but would also “like to see the data.” Health and Human Services Secretary Robert F. Kennedy Jr. and some of his supporters have criticized that technology as unsafe.
“We’re not going to get ahead of the game,” he said. “We’re going to basically say, we’d like to see the data, how far mRNA technology can be applied is a question where we’d love to see it applied, as far as it can be applied, but it’s got to meet our scientific standards, so we’ll see what it gets with cancer, with other infectious diseases. …”
China
Makary also warned that the U.S. is falling behind China in early-stage drug development and called for reforms to streamline how new treatments enter clinical trials.
China’s biotech sector has expanded rapidly in recent years, fueled by heavy state investment, deep talent pools and faster regulatory timelines. U.S. policymakers have faced mounting pressure to boost domestic innovation rather than attempt to stymie it in China.
“We walked into a mess,” Makary said, referring to the gap between the U.S. and China in phase one trials conducted in 2024.
Makary pointed to three key bottlenecks: hospital contracting, ethics reviews and approvals, and the process for submitting Investigational New Drug (IND) applications that allow companies to begin human testing.
He described the first two as “clunky processes that take too long and are leaving us non-competitive with the countries that are moving a lot faster.” For the latter, he said the FDA has added too many questions to the application over the years.
“They’ve never removed questions,” he said. “If a question has had the same affirmative answer the last 10,000 out of 10,000 times, then why are we asking?”
He said the FDA is “looking at everything,” including potential partnerships with health systems and academic medical centers to speed up the pre-IND process.
The Trump administration should “partner with industry to help them deliver more cures and meaningful treatments for the American public,” Markary said, calling the effort a “bipartisan priority.”
Feel free to send any tips, suggestions, story ideas and data to Annika at a new email: annika.constantino@versantmedia.com.
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