FDA Chief Marty Makary on GLP-1 Copies, Vaccines and China

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This week, I had the opportunity to sit down with Dr. Marty Makary, Commissioner of the Food and Drug Administration, during a trip to Washington, DC.

Our conversation came amid a contentious run for the FDA, defined by a leadership transition, massive staff and budget cuts, and sweeping changes to the agency's vaccine policy and drug approval approach. More recently, his back-and-forth over Moderna's flu vaccine has fueled industry concerns about regulatory consistency.

Here's what Makary had to say about some of the most important issues for the pharmaceutical industry.

Check out my interview with Makary here.

Makary said the FDA is “seriously” about the decision to crack down on massive, illegal compounding of GLP-1.

This comes on the heels of the FDA announcing plans to take action against telehealth company Hims & Hers, which has mass-marketed compounded versions of Nordisk's Wegovy pill and injections.

The FDA said it plans to restrict GLP-1 ingredients used in unapproved compounded drugs, citing concerns about quality, safety and potential violations of federal law.

Makary said brand-name drug makers go through the FDA process “appropriately” by conducting clinical trials that demonstrate a product's benefit. The agency also regulates marketing claims for those drugs, such as requiring ads to reflect side effects.

But Makary said, “Sometimes what we've seen is companies that are violating those regulations.” The FDA is “talking directly to these companies and telling them that they have to follow the rules,” he added.

When asked if the year 2026 could be the end of illegal mass compounding of GLP-1, Makary said: “I hope so.” The FDA is seeing more companies sourcing their active pharmaceutical ingredients from Novo Nordisk and Eli Lilly, “and that system has a path to work.”

“Yeah [Novo and Lilly] “They are providing APIs and the composition meets the regulation, so the more competition the better,” he said.

Notably, my conversation with Makary came a day before the FDA agreed to review Moderna's experimental mRNA flu vaccine, reversing the agency's earlier decision to decline to accept the application. The FDA is now scheduled to decide whether to approve the flu vaccine on August 5.

Makary did not indicate that the agency would change its decision. Instead, he said the FDA's guidance to Moderna on its vaccine “was pretty clear.”

“I think the FDA's individual guidance process, when companies meet with FDA scientists, is pretty robust, and that guidance is pretty clear about how they want the trials to be designed,” he said.

The agency recommended that the group of study participants 65 and older who did not receive the Moderna vaccine receive “standard care, not substandard care” as a comparison product, Makary said. Previous FDA comments 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, pointing out that FDA rules and guidelines do not actually require trials to use the more advanced or higher-dose vaccine as a comparator in clinical studies. The company has also said it is inconsistent with the FDA's previous written communication about the trial design, even before the study began, where the agency said using the standard flu vaccine would be “acceptable.”

When asked about his stance on mRNA technology, Makary said he is “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 the technology as unsafe.

“We're not going to get ahead of the game,” he said. “We're basically going to say, we'd like to see the data, to what extent mRNA technology can be applied is a question that we would love to see applied, to the extent that it can be applied, but it has to meet our scientific standards, so we'll see what happens with cancer and with other infectious diseases…”

Makary also warned that the United States is falling behind China in early-stage drug development and called for reforms to streamline the way new treatments enter clinical trials.

China's biotech sector has expanded rapidly in recent years, driven by strong state investments, deep talent pools and faster regulatory timelines. U.S. officials have faced increasing pressure to boost innovation at home rather than try to hinder it in China.

“We got ourselves into a mess,” Makary said, referring to the gap between the United States and China on phase one trials conducted in 2024.

Makary pointed to three key hurdles: 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 much time and leave us uncompetitive with countries moving much faster.” For the latter, he said the FDA has added too many questions to the application over the years.

“They've never eliminated questions,” he said. “If a question has had the same yes answer the last 10,000 out of 10,000 times, why do we ask?”

He said the FDA is “looking at everything,” including possible partnerships with health systems and academic medical centers to speed up the pre-IND process.

The Trump administration should “partner with the industry to help them deliver more meaningful cures and treatments to the American public,” Markary said, calling the effort a “bipartisan priority.”

Feel free to send any tips, suggestions, story ideas and facts to Annika at a new email: [email protected].