America First Legal (AFL) filed a lawsuit against the Food and Drug Administration on Friday to obtain Biden-era records regarding the government’s internal guidance on the recommended use of puberty blockers for children.
The Trump-aligned legal group previously obtained communications from the former administration through a Freedom of Information Act (FOIA) request. Those documents reportedly indicated that the FDA was aware these drugs increased mental health risks, yet still recommended their approval for children.
Following this discovery, AFL submitted a separate FOIA request seeking documents specifically related to the FDA’s internal guidance on the off-label use of puberty blockers. Although the FDA acknowledged the request, it has not complied, and the deadline to produce the documents has passed.
“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.
America First Legal, a Trump-aligned group, is suing to access Biden-era records related to the FDA’s recommended guidance on puberty blockers for gender-dysphoric children.
Similar to its previous FOIA effort, AFL had to engage in litigation to obtain the first batch of documents. Ultimately, those documents appeared to show that the Biden-era Division of General Endocrinology at the FDA recommended approving puberty blockers for children despite being aware of potential negative effects, including 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 obtained by AFL. The communication also noted that studies had identified “increased risk of depression and suicidality, as well as increased seizure risk.”
These findings align with results from other research.
Researchers at the University of Texas analyzed 107,583 patients aged 18 and older with gender dysphoria, including some who had undergone gender surgery, concluding that “gender-sensitive mental health support … to address post-surgical psychological risks” is essential.
Among males who had surgery, depression rates were 25%, compared with just under 12% for those without surgery. Anxiety rates were 12.8% versus 2.6%.
Similar patterns appeared in females: those who underwent surgery had depression rates of 22.9% compared to 14.6% in the non-surgical group, and anxiety rates were 10.5% versus 7.1%.
