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FDA sued for concealing information about children's off-label use of puberty blockers, cross-sex hormones
The Food and Drug Administration (FDA) was sued Monday by Stephen Miller's conservative group America First Legal for supposedly illegally concealing records pertaining to the off-label use of puberty blockers and cross-sex hormones on children.
AFL filed a Freedom of Information Act (FOIA) request in September asking for all records from the first day of the Biden presidency to the completion of the request regarding the use of puberty blockers and cross-sex hormone drugs on children, commonly referred to as "gender-affirming care."
The FDA still has not responded to AFL’s FOIA request as required by law, according to the lawsuit, so the non-profit is suing the government agency to get them to release the records "on behalf of the American public." AFL asserts that by failing to release the records, the FDA has violated FOIA and is depriving the American public of necessary information as it pertains to the off-label use of gender-affirming drugs in children.
"The FOIA’s purpose is to ensure an informed citizenry, vital to the functioning of a democratic society, needed to check against corruption and to hold the governors accountable to the governed," AFL's lawsuit states. "By failing to comply with the FOIA, the FDA is depriving AFL and the public of vital information needed to evaluate FDA’s compliance with the law regarding the off-label use of puberty blockers and cross-sex hormones on children."
Puberty blockers and cross-sex hormones have been criticized as experimental treatments for gender dysphoria, which can lead to sterilization and other serious health complications like depression, blood clots, high blood pressure and weight gain.
The FDA recently added a warning to the labeling for the gonadotropin-releasing hormone (GnRh) agonists about the risk of pseudotumor cerebri, which occurs when the pressure inside your skull increases and mimics symptoms of a brain tumor, which can cause swelling and result in vision loss.
The FDA has approved GnRh agonists for treating precocious puberty, prostate and breast cancer, endometriosis, for use in vitro fertilization and to perform chemical castration, according to AFL's FOIA request. Even though GnRh agonists have not been approved for use as puberty blockers in children with gender dysphoria, doctors have used them as treatment for transgender children, the FOIA states.
"The recent allegations from a whistleblower at the Washington University Transgender Clinic at St. Louis Children’s Hospital is just the latest obvious warning of the dangerous experimentation on children with off label drugs like Lupron and other puberty blockers and cross-sex hormones," Ian Prior, America First Legal senior advisor said in a statement. "Yet, while European nations are pulling back on these dangerous practices, America is putting them into warp speed with the backing of the Biden Administration."
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"The American people deserve to know exactly what its government is doing and if we have to take the FDA to court to find out, so be it," he added.
The FDA did not immediately respond to Fox News Digital's request for comment.
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