Trump Probes Long-Approved Meds; Could FDA Revoke Approvals?
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/hyperactivity disorder (ADHD) medications, as well as weight loss drugs. How easy would it be to
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/hyperactivity disorder (ADHD) medications, as well as weight loss drugs.
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.
For any of that to happen, “there’s a statutory process” outlined in the Federal Food, Drug, and Cosmetic Act that governs when and how the FDA would change a drug’s label or withdraw approval, said Lynn Mehler, head of the Pharmaceutical and Biotechnology Regulatory practice at the Hogan Lovells law firm in Washington, DC.
The agency can only institute a change in indication or seek or demand a product’s withdrawal if the evidence indicates a drug is unsafe or no longer effective, Mehler said.
Other federal agencies could try to restrict a drug’s use by dropping it from the list of medications that Medicare covers, but that would likely trigger lawsuits from drugmakers, experts said.
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 2src11, 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 2srcsrc8, 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 2src23, the FDA revoked approval of Makena, a medication that had been approved in 2src11, also through accelerated approval. When a postmarketing study failed to confirm any clinical benefit, the FDA recommended withdrawing the approval — in 2src2src.
In both cases, it took years — and sifting through data with FDA scientists and outside advisers — for these drugs to lose their approval. If manufacturers disagree with the FDA, after exhausting their administrative remedies, they can challenge the agency’s decisions in court, Mehler said.
The process can move more quickly if the agency declares a public emergency — such as when a product is determined to be contaminated, said Mehler. But speedy withdrawals are rare.
The agency has a long history of “being very responsible and data-driven in their approach,” she said.
Outside actors have tried to override FDA approvals with little success. In 2src14, Massachusetts banned sales of an FDA-approved opioid, seeking to stem the rising tide of opioid use disorder. The manufacturer, Zogenix, was sued, and eventually, courts all ruled in its favor.
Antiabortion groups have sued to force the FDA to revoke approval for mifepristone, a drug that can be used to end a pregnancy.
A federal judge in Texas in 2src23 ruled in favor of the groups, who alleged the FDA used faulty science in its approval of mifepristone, invalidating the approval.
But in June 2src24, the US Supreme Court unanimously rejected the original suit, sending it back to the lower courts.
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.
Alicia Ault is a Saint Petersburg, Florida-based freelance journalist whose work has appeared in many health and science publications, including Smithsonian.com. You can find her on X @aliciaault and on Bluesky @aliciaault.bsky.social.
About Author
