Thursday, October 2, 2025

Lawsuit filed against FDA for alleged cover-up of puberty blocker records

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Introduction to the Lawsuit

A lawsuit was filed by America First Legal (AFL) against the Food and Drug Administration (FDA) to obtain records related to the government’s internal guidance for the recommended use of puberty blockers for kids. The lawsuit comes after the Trump-aligned legal group 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.

Background of the FOIA Request

Following the uncovered communications, AFL submitted a separate FOIA request for 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.

Previous Litigation and Document Release

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. 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.

Findings and Studies

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.

Supporters of transgender youth demonstrated outside of Children’s Hospital Los Angeles (CHLA) on Feb. 6, 2025. AFP via Getty Images

FDA Response and Next Steps

Fox News Digital reached out to the FDA for comment but did not immediately receive a response. The lawsuit highlights the ongoing debate and concerns surrounding the use of puberty blockers for kids. As the case progresses, it is likely to bring more attention to the issue and the need for transparency in government decision-making.

Conclusion

The lawsuit filed by America First Legal against the FDA seeks to uncover the truth about the government’s internal guidance for the recommended use of puberty blockers for kids. The case has already revealed concerning information about the potential risks associated with these drugs, and the need for greater transparency and scrutiny in government decision-making. As the debate surrounding this issue continues, it is essential to prioritize the well-being and safety of children and to ensure that any treatments or interventions are based on the best available evidence and free from political influence.

FAQs

Q: What is the lawsuit about?
A: The lawsuit is about America First Legal (AFL) suing the Food and Drug Administration (FDA) to obtain records related to the government’s internal guidance for the recommended use of puberty blockers for kids.
Q: What did the previous FOIA request reveal?
A: The previous FOIA request revealed that the FDA knew that puberty blockers increased mental health risk but still recommended approving them for kids.
Q: What are the potential risks associated with puberty blockers?
A: The potential risks associated with puberty blockers include increased depression, suicidality, and seizure risks.
Q: What is the FDA’s response to the lawsuit?
A: The FDA has not cooperated with the FOIA request, and the deadline to produce documents is up. Fox News Digital reached out to the FDA for comment but did not immediately receive a response.

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