A conservative legal group aligned with former President Trump is suing the U.S. Food and Drug Administration (FDA) for unlawfully withholding records on the Biden administration’s handling of puberty blockers and cross-sex hormones used off-label for children.
America First Legal filed the lawsuit on Friday in the U.S. District Court for the District of Columbia after waiting more than a year for a response to a Freedom of Information Act request. The group submitted its request on August 5, 2024, asking for documents and communications from senior FDA officials about the use of puberty blockers such as Lupron, leuprorelin, and other gonadotropin-releasing hormone agonists in minors. According to the filing, the FDA acknowledged receipt of the request but failed to produce a single page of records.
The lawsuit demands the release of all responsive documents from January 21, 2021, to the present, covering the tenure of top FDA officials, including Center for Drug Evaluation and Research Director Patrizia Cavazzoni, Division of General Endocrinology Director Theresa Kehoe, and Deputy Director Naomi Lowy. AFL argues these records are essential to understanding what FDA leaders knew about the risks of puberty blockers in children and whether politics drove the agency’s decision-making.
According to AFL, the records are critical to understanding whether FDA officials were aware of the harms associated with off-label use of puberty blockers, including depression, suicidality, seizures, and cognitive impairment. The group previously obtained internal FDA emails showing agency staff acknowledged elevated risks of suicidality and depression tied to these drugs, yet still advanced their approval for pediatric use.
“This is what lawlessness looks like: hiding evidence of harm, ignoring legally-binding deadlines, and prioritizing ideology over children’s lives. AFL is taking the FDA to court to give the American people what they deserve: the truth,” said Ian Prior, Senior Counsel for AFL.
Counsel Will Scolinos said, “It is time to pull back the curtain on what public officials really knew about the risks of the treatments they so confidently recommend to our most vulnerable.”
The lawsuit also noted that several European countries, including Sweden, Finland, France, and the United Kingdom, have moved to restrict the use of puberty blockers in minors, citing insufficient evidence of safety and effectiveness. AFL argues that while governments abroad have acted with caution, the FDA has expanded access without full transparency.
The FDA has not publicly responded to the lawsuit. AFL has requested that the court compel the agency to produce the requested records and award attorneys’ fees and costs.
The lawsuit was filed just days after a transgender shooter opened fire at a Catholic church in Minneapolis, killing two children and wounding 18 others.
