Trump admin backs off claims synthetic vitamin could help autism 

Trump admin backs off claims synthetic vitamin could help autism 

Despite stating from the Oval Office last year that the Food and Drug Administration (FDA) would be promoting leucovorin as a potential treatment for symptoms of autism, senior administration officials said there wasn’t “sufficient data” to support these claims when announcing new approvals for the drug this week.

AP Photo/Manuel Balce Ceneta

The FDA on Tuesday announced it was approving Wellcovorin, a prescribed, synthetic form of vitamin B9 also called leucovorin calcium, for cerebral folate deficiency in children and adults with a confirmed variant in the folate receptor 1 gene (CFD-FOLR1). 

According to the National Organization for Rare Disorders, there were less than 20 individuals who had been documented in medical literature with the disease in 2019. 

In September, the FDA said it had initiated the process of making leucovorin available for treating symptoms of autism, at the same time President Trump told pregnant women to “fight like hell” to not take Tylenol on the claim that it could be linked to autism, despite there being no new evidence of that. 

“Hundreds of thousands of kids, in my opinion, will benefit. One study found that with kids with autism and chronic folate deficiency, two-thirds of kids with autism symptoms had improvement and some marked improvement,” FDA Commissioner Marty Makary said in September. 

Children with CFD often present with symptoms that resemble those of autism spectrum disorder due to their brains not receiving enough folate. With how rare the condition is, however, the majority of autistic children do not have this condition.

The American Academy of Pediatrics has previously said that evidence supporting leucovorin use in autistic children is “currently limited,” a consensus that senior administration staffers echoed. 

“Right now, we don’t have sufficient data to say that we could establish efficacy for autism more broadly,” an official noted during a press briefing, adding that off-label use might be an option. “It’ll be up to patients to talk with their physicians to see if that might be right for them.” 

Welcome to The Hill’s Health Care newsletter, I’m Joseph Choi — every week we follow the latest moves on how Washington impacts your health.

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How policy will be impacting the health care sector this week and beyond:

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Branch out with a different read:

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Local and state headlines on health care:

State-run health marketplace may be ‘too little, too late,’ insurance commissioner says (Mississippi Today) 

Uninsured rate in Minnesota spikes, climbing to the highest level in 6 years (Minnesota Public Radio) 

A Missouri pilot program reimagines rural hospitals as the central hub for more than health care (The Beacon) 

Health news we’ve flagged from other outlets:

RFK Jr.’s MAHA allies call to eliminate all childhood vaccine recommendations (NOTUS) 

Another study finds no ties between Tylenol in pregnancy and autism (MedPage Today) 

Removing race from kidney function algorithm helped more Black patients access transplants (Stat) 

Opinions related to health submitted to The Hill:

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