Alicia Ault, Medscape, March 6, 2025
Long-approved drugs with decades of safety data are facing new scrutiny amid a charged political environment.
The Trump administration’s new “Make America Healthy Again (MAHA) Commission” will investigate what it calls “the threat posed” to children by psychiatric and attention-deficit/
How easy would it be to revoke US Food and Drug Administration (FDA) approvals for drugs regarded as generally safe and effective? Not very, experts said.
Any attempt would require many public meetings and take years, said Diana Zuckerman, PhD, president of the nonpartisan National Center for Health Research in Washington, DC
“Rescinding approval is very difficult to do,” said Zuckerman, a former science policy advisor to former President Bill Clinton.
Commission Led by Robert F. Kennedy, Jr
The MAHA commission will examine chronic disease in children and whether some medications may contribute to those conditions. The drugs, cited in an executive order establishing the Commission, include “prescription of selective serotonin reuptake inhibitors [SSRIs], antipsychotics, mood stabilizers, stimulants, and weight loss drugs.”
Studies have shown that SSRIs are well tolerated and have fewer side effects and overdose risk than older classes of antidepressants. ADHD stimulant medications are similarly considered generally safe and well tolerated.
Led by Health and Human Services Secretary Robert F. Kennedy, Jr — a skeptic of vaccines, antidepressants, and weight loss drugs — the Commission will include heads of at least a dozen government agencies, including the FDA, Centers for Disease Control and Prevention, and the National Institutes of Health.
By mid-August, the Commission could recommend that the FDA restrict use or revoke the medications’ approval for children.
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Safety Concerns Prompted Prior Recalls
The FDA has taken such action before, said Mehler, who previously worked in the Office of Regulatory Counsel at the FDA. In 2011, the agency revoked approval of bevacizumab (Avastin) for metastatic breast cancer, citing a lack of safety and effectiveness. The therapy had been approved for that indication in 2008, under an accelerated approval pathway that required additional studies. Those studies showed the benefits did not outweigh the risks from side effects, said the agency.
In 2023, the FDA revoked approval of Makena, a medication that had been approved in 2011, also through accelerated approval. When a postmarketing study failed to confirm any clinical benefit, the FDA recommended withdrawing the approval — in 2020.
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Evidence-Based Decisions Welcomed
Zuckerman said she welcomed a look at some of the medications being used in children.
“I’ve had some very serious concerns about the approval process for psychotropic drugs,” Zuckerman told Medscape Medical News.
She said she had raised concerns at FDA advisory committee meetings and with previous FDA commissioners, in particular about the potential long-term impact on children’s brains and mental health.
“I don’t know what to make of this Commission,” she said, adding that she aimed to be open-minded. “I think it’s a good idea,” said Zuckerman, but, she added, she’d like to see people on the committee who are “research experts and statistical experts” and who focus on the evidence.
The National Center for Health Research does not receive any industry funding.
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