Makary asks FDA staff to keep an open mind to solve chronic health problems

Martin Makary, the newly-confirmed commissioner of the US Food and Drug Administration (FDA), emphasized the need to challenge “deeply held assumptions” and use science and common sense to address America’s health care problems. He noted that health outcomes in the US have significantly deteriorated over the last generation, and the agency needs to do its part to address them.

On 2 April, Makary held an all-hands staff meeting at FDA’s White Oak headquarters in Silver Spring, MD, where he outlined his vision for the agency just one day after it laid off thousands of its staff. He repeated many of the things he said during his Senate confirmation hearing and spoke about the need for humility and common sense to address America’s chronic health problems. (RELATED: Makary commits to review FDA staff cuts, VRBPAC cancelation in Senate confirmation hearing, Regulatory Focus 6 March 2025)

"Now more than ever, we need people with a range of perspectives and critical thinkers to respond following the scientific method and using common sense,” he said. “The FDA is America's health and safety hub for the world's innovators. It's also the hub of scientific discourse at the highest level in healthcare, which is why I consider it a tremendous honor to be joining you here at the agency."

Makary also emphasized that Americans are unhealthier and have shorter lifespans compared to the previous generation, and there’s been an increased rate of diseases such as autism. Many of these issues have also been raised by Department of Health and Human Services (HHS) Secretary Robert Kennedy Jr.

"America is not getting healthier as a population, the country is getting sicker,” said Makary. “It is almost as if our healthcare system and those in it have been so busy telling clinicians to focus on billing and coding and seeing patients in short visits at high volume, with throughput being the metric, that we haven't had time to stop and look around.”

“If we pause and take a serious look at the statistics, they are telling us one simple message: that our nation's children are not on a good path,” he added. “Our country desperately needs you and your ideas. They need FDA's scientists to ensure public safety and examine root causes of other medical problems that are unforeseen using the disciplines of toxicology, environmental health, food safety, and basic scientific methodology.”

Makary said the “new chronic disease epidemic” means there is a need for new therapies and treatments that require new approaches and ideas. He said FDA needs to be willing to listen to differing ideas to find such solutions.

“We have to have a humility to follow what the evidence may tell us, challenging our preconceived ideas,” said Makary. “Challenging what we believe to be true, challenging deeply held assumptions that lack evidence, and allowing experts to debate new approaches to old problems is exactly what we need right now.”

"Science is based on humility, an approach that is so impeccably open to what the data may show that one is willing to change their view based on new evidence,” he added. “Changing position is not a weakness; it's a strength when the evidence evolves. This approach is critically important because we face some major challenges."

Makary also referenced the mass layoffs that occurred the day before under President Donald Trump’s reduction in force (RIF) initiative. (RELATED: Thousands of FDA staff fired in latest RIF, Regulatory Focus 1 April 2025)

"I know the last few months have been difficult and the last few days have been particularly hard,” said Makary. “I want you to know that you have my commitment that I will do everything possible to make sure that scientists, clinicians, inspectors, investigators, and core staff central to the mission and operations of this agency will have all the resources they need to do their job, and I will do my best.”

Agency sources who spoke to Focus and were granted anonymity due to fear of professional reprisal said they did not find Makary’s words comforting or assuring, especially considering the loss of so many colleagues. One source described the speech as “bizarre,” while another said it was “tone deaf” as it focused more on Makary’s personal stories and less on what he was bringing to FDA to ensure the agency could accomplish its public health mission.

Sources said some people in the Great Hall where Makary spoke applauded him, but the staff in the overflow rooms where they broadcast the speech didn’t. They also said they were very disappointed that he only addressed the staff being fired in one sentence, which they felt was disingenuous. Sources also found FDA deputy principal commissioner Sara Brenner’s “cheery” disposition during the meeting inappropriate, considering how they were all still processing the recent layoffs.

“I found no comfort in that speech. Putting aside the personal stories that brought little relevance, he talked about encouraging civil discourse,” said the source. “It missed the mark. FDA employees don’t bring politics into our work.”

“When he now says, scientific method plus common sense, reading between the lines, he doesn’t want to just rely on what the evidence says,” the source added.

Another source said they and their colleagues don’t believe he will focus on science-based evidence or that he will be willing to fight for FDA staff.

“He said some things that were related to the scientific method and being open-minded if the data takes you in another direction, which is a fair and reasonable point,” said the source. “However, a lot of us that that was inauthentic.”

“A lot of us seemed to feel that it was just boilerplate talking points with not too much oomph,” the source added. “We just don’t think he’ll go against the bosses.”

Other sources noted that his speech focused on areas that FDA doesn’t oversee, such as clinical practice in prescribing opioids or reimbursement.

“There was nothing about what FDA actually does and what he’ll do,” said a source. “It was regurgitating a lot of [Kennedy’s Make America Healthy Again (MAHA)] talking points with some of his book anecdotes thrown in.”

The FDA sources also noted that Makary’s speech did not mention the ongoing measles outbreak or the recently canceled Vaccines and Related Biological Products Advisory Committee meeting to review influenza vaccine composition for the 2025-2026 flu season.

“Our mission is to protect the public health, and nowhere in his speech did he talk about immediate priorities and threats,” said a source. “This was the first speech I heard that was very disconnected from the mission of FDA and felt like a shadow of RFK.”

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Makary asks FDA staff to keep an open mind to solve chronic health problems

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