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Legal group sues FDA over puberty blocker records, citing alleged Biden-era cover-up

by August 30, 2025
written by August 30, 2025

America First Legal (AFL) sued the Food and Drug Administration on Friday to obtain Biden-era records related to the government’s internal guidance for the recommended use of puberty blockers for kids.  

The Trump-aligned legal group previously uncovered communications from the former administration through a Freedom of Information Act (FOIA) request, which reportedly showed the FDA knew that these drugs increased mental health risk but still recommended approving them for kids.

Following those uncovered communications, AFL followed up with a separate FOIA requesting documents specifically pertaining to the FDA’s internal guidance for the off-label use of these drugs. Despite acknowledging the federal information request, the FDA has not cooperated, and the deadline to produce documents is up.

 

‘The Biden administration pushed gender-denying treatments on American kids. Now, it’s time to expose what officials really knew,’ AFL counsel Will Scolinos, said. 

Similar to AFL’s current FOIA request, the group was required to engage in litigation to compel the release of the first set of documents. 

But, eventually, documents were released that seemed to show the Biden-era Division of General Endocrinology at the FDA recommended the agency approve puberty blockers for children despite the knowledge that there were negative impacts associated with them, such as increased depression, suicidality and seizure risks.

‘There is definitely a need for these drugs to be approved for gender transition,’ an FDA official from the agency’s endocrinology division stated in an email uncovered by AFL. In the same communications, the FDA official also explicitly states that studies found ‘increased risk of depression and suicidality, as well as increased seizure risk.’

Such findings have been confirmed by other studies as well.

Researchers at the University of Texas sampled 107,583 patients 18 and older who had gender dysphoria, including some who underwent gender surgery, and concluded that ‘gender-sensitive mental health support … to address post-surgical psychological risks’ is a ‘necessity.’

 

Males who received surgery had depression rates of 25% compared to males without surgery, who had rates slightly below 12%. Anxiety rates among that group were 12.8% compared to 2.6%.

The same differences were seen among females as well. Those with surgery had 22.9% depression rates compared to 14.6% in the non-surgical group. Females who did get surgery also had a rate of anxiety of 10.5% compared to 7.1% for girls who had not gotten surgery.

Fox News Digital reached out to the FDA for comment but did not immediately receive a response. 

Fox News’ Melissa Rudy and Michael Dorgan contributed to this report

This post appeared first on FOX NEWS
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