Ex-FDA Official Is Worried About the FDA's New "Anti-Vaccine Tone"

Dr. Peter Marks is the kind of health official both Democrats and Republicans used to admire. He served in the U.S. Food and Drug Administration (FDA) for 13 years, most of them as director of the Center for Biologics Evaluation and Research. There, Marks oversaw the critical process of reviewing and approving vaccines—like those against COVID-19—and biologic therapies, including gene- and cell-based treatments.

Marks earned trust and respect from academic and industry scientists as well for his emphasis on requesting the strongest evidence in evaluating new therapies, and for his willingness to support new technologies and approaches.

But he did not last long in the new Trump Administration. On March 28, Marks resigned after he says he was pressed by Department of Health and Human Services (HHS) officials to come in line with skepticism about the safety and effectiveness of vaccines or be fired. He says his team was also asked by HHS to turn over sensitive health information from the database the FDA maintains with the U.S. Centers for Disease Control and Prevention (CDC) to track adverse reactions to vaccines. Concerned about how the data would be used, Marks refused and resigned. (HHS did not immediately respond to a request for comment for this story.)

Now, he is warning of a fundamental change at HHS and the FDA—one he believes is already proving to be very dangerous. “What I saw at the agency was an increasing anti-vaccine tone,” he told TIME On April 8. “I was hoping to work through it, but it was very clear to me that they just didn’t want to work through it.”

A clash about vaccines

Since Robert F. Kennedy Jr., a long-time vaccine skeptic, was appointed to head HHS, the agency has removed pro-vaccination public service ads made by the CDC, and it missed a deadline to decide whether or not to approve a COVID-19 vaccine from Novavax.

Marks, aware of Kennedy’s position on vaccines, began in November to draft a “package of things we could do to hopefully try to address some of the issues” that anti-vaccine groups have. “I’ve been trying to reach out and say ‘I’m willing to meet you halfway,’” says Marks.

He came up with a four-point proposal on how the FDA could accomplish that. First, the agency would reassess how vaccines are labeled. “Vaccine labeling over the course of several decades has gotten very messy,” he says. “And the information for the patient is not as clear as it could be. That is a fact, and a legitimate criticism. We would look at ways to clean up labels and make them more transparent.”

The FDA would also hold listening meetings to hear from people about their concerns about the components that go into vaccines—such as thimerosal, which was removed from the MMR (measles) vaccine and other childhood vaccines in 2001 but is still used in some flu shots—along with vaccine safety and efficacy. The FDA already uses this practice while it reviews any major drug and vaccine, inviting the public to provide comments to its advisory committee of independent experts before the group votes on whether to approve a product.

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Marks offered to have the FDA ask the National Academy of Medicine—a nonprofit, independent group that evaluates scientific questions to inform policy and improve the health of Americans—to study any of Kennedy’s concerns about vaccines, such as the role of adjuvants, which are ingredients to boost the body’s immune response.

And the FDA proposed revising the current system for reporting side effects or adverse events related to vaccines, so that the process of evaluating them and determining if they are reasonably linked to vaccines could become more transparent.

But Marks says he didn’t receive any response or feedback on these proposals before he left the organization. Dr. Marty Makary, nominated by President Trump, was sworn in as the new FDA director on the day Marks submitted his resignation and signed off on Marks’ departure shortly after taking office.

The measles fallout

The change in tone among the top U.S. health agencies has coincided with an ongoing measles outbreak, which has killed two children and caused hundreds of infections. “I was so disturbed when I heard about the second measles death in a child that I used profanity with a reporter without realizing it,” Marks says. “Anyone who knows me would know that’s something I never do. I was so disturbed, and remain disturbed, because this is absolutely needless.”

As head of the FDA section that was responsible for reviewing data submitted by vaccine makers to approve their vaccines, Marks reiterates that the data supporting the safety and effectiveness of the measles vaccine is both clear and robust. “Measles vaccine is one of the safest, most effective vaccines we have,” he says. “Unlike other vaccines, which you might be able to argue about whether people should take them or not, the measles vaccine that has been given to children saves lives. It saves lives because one in 1,000 children who get measles die up front. Another one in 10,000 to 20,000 children die a few years later from persistent measles infection in the brain. So it saves lives. The measles vaccine is not associated with death, encephalitis, autism, or long-term adverse effects.”

Still, Kennedy has reportedly appointed vaccine critic David Geier, whose research on vaccines and autism has been discredited by judges and medical professionals alike, to study data on the safety of the MMR vaccine and a link to autism—despite the fact that scientists say any connection has been debunked for decades.