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WASHINGTON, D.C. – America First Legal (AFL) has filed a federal lawsuit against the Food and Drug Administration (FDA) in the U.S. District Court for the District of Columbia for allegedly failing to release Biden Administration-era records relating to the off-label usage of puberty blockers for children. These records could reveal devastating risks the FDA knew—at the same time the Biden Administration was pushing radical transgender ideology on the public—but have not disclosed, leaving parents and the public in the dark.
On August 5, 2024, AFL submitted a Freedom of Information Act (FOIA) request seeking records related to specific off-label use of puberty blockers and cross-sex hormones. The FDA acknowledged receipt of the request the following day, stating it would require an additional ten days beyond the statutory twenty-day deadline to respond. Then, it went silent for more than a year.
This is just the latest action AFL has taken to ensure the public is fully aware of the risks of "gender affirming" treatments that are being offered to minors across the country. In another FOIA lawsuit, AFL uncovered internal FDA communications acknowledging that puberty blockers pushed by the Biden Administration increase the risks of suicide, depression, and seizures when given to children. Despite these admissions, federal officials continued to emphasize the importance of securing full FDA approval for the use of puberty blockers in children.
Meanwhile, several European countries—including Sweden, France, Finland, and the United Kingdom—have walked back the practice of prescribing puberty blockers and cross-sex hormones for minors, citing insufficient long-term research and the growing number of detransitioners.
“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 America First Legal.
“The Biden Administration and the mainstream media spent years recommending gender denying treatments to American children. 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,” said Will Scolinos, Counsel for America First Legal.
“America needs to take a hard look at how it’s allowed deranged ideology to drive its healthcare policies. From what we were able to uncover, the Biden FDA knew of clear psychiatric harm to children, yet encouraged full approval of these medications for gender transition. The American people deserve to know the full truth so we can hold any holdovers from the prior administration accountable,” said Laura Stell, Counsel for America First Legal.
Read the filing here.
Read more about the case here.
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