Americas First Legal (AFL), a legal group aligned with former President Donald Trump, has filed a lawsuit against the U.S. Food and Drug Administration (FDA) to obtain records on the agency’s internal guidance regarding the use of puberty blockers for children. This marks the latest development in a series of legal disputes concerning the administration’s approach to gender-affirming care for minors. The lawsuit follows previous disclosures of internal FDA communications, which revealed that officials were aware of the potential risks associated with puberty blockers but still recommended their use for minors under the Biden administration.
Previous disclosures, obtained through a Freedom of Information Act (FOIA) request, showed that the FDA’s Endocrinology Division had recommended the approval of puberty blockers for children despite knowing the potential negative impacts, including increased depression, suicidality, and seizure risks. This revelation prompted AFL to submit a follow-up FOIA request for documents specifically related to the FDA’s internal guidance on the off-label use of these drugs. Despite acknowledging the FOIA request, the FDA has not cooperated, and the deadline for producing the documents has passed, leading to the current lawsuit.
AFL counsel Will Scolinos stated that the Biden administration has been accused of promoting gender-denying treatments on American children and that it is time to expose what officials truly knew. The legal group’s previous FOIA request led to the release of documents that revealed the FDA’s Endocrinology Division recommended the approval of puberty, despite knowing the potential negative impacts. One of the disclosed communications included an email from an FDA official stating that studies found increased risk of depression and suicidality, as well as increased seizure risk.
These 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 had undergone gender surgery. The study concluded that gender-sensitive mental health support is a necessity to address post-surgical psychological risks. The findings reveal that male patients 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. Despite reaching out to the FDA for comment, Fox News Digital did not immediately receive a response. This case represents a significant moment in the ongoing debate over the use of puberty blockers for minors and the role of regulatory agencies in approving these medications.