Legal Action Seeks Internal FDA Records on Puberty Blocker Guidance

America First Legal (AFL) has filed a lawsuit against the Food and Drug Administration to access documents regarding the agency’s internal guidelines on the use of puberty blockers for minors during the Biden administration.

The conservative-leaning group previously obtained communications indicating that, under the prior administration, the FDA was aware that these drugs could pose mental health risks, including increased depression and suicidality, yet still recommended their approval for children.

Following this discovery, AFL submitted a Freedom of Information Act (FOIA) request for specific documents related to the FDA’s internal advice on off-label use of puberty blockers. The agency has acknowledged the request but has yet to release the documents, prompting legal action to compel transparency.

According to AFL counsel Will Scolinos, the group aims to reveal what officials knew about potential harms when promoting treatments aligned with gender transition for minors.

Eventually, some internal documents surfaced, suggesting that the FDA’s Division of General Endocrinology recommended approving puberty blockers despite evidence of risks such as depression, seizures, and increased suicidality. An FDA official explicitly stated that studies indicated these adverse effects, even though they supported the drugs’ use for gender affirmation.

Research from the University of Texas, involving over 107,000 adults with gender dysphoria, found significant mental health disparities among those who underwent gender-affirming surgeries. Depression rates in surgical patients were approximately 26%, compared to about 12% in non-surgical individuals, with anxiety similarly higher in the surgical group.

Supporters of transgender youth demonstrated outside a Los Angeles hospital, reflecting ongoing public debates surrounding gender-affirming treatments for minors.

While the FDA did not respond to inquiries, these findings contribute to the broader discussion about safety, mental health, and the long-term impacts of gender transition procedures in young people.