When the new guidance was declared in March 2022, Assistant Secretary for Health Rachel Levine, who is a biological male yet identifies as a transgender woman, inaccurately declared, "there is no argument among medical professionals—pediatricians, pediatric endocrinologists, adolescent medicine physicians, adolescent psychiatrists, psychologists, etc.—about the value and the importance of gender-affirming care."
This HHS guidance document, titled "Gender Affirming Care in Young People," has been heavily critiqued for its unscientific claims. Hans Bader, a lawyer in D.C. who filed the lawsuit, discovered that The Office of Population Affairs was responsible for writing the HHS guidance. He stressed that the HHS agency best prepared to extend its expertise on drugs and treatments would be the FDA. He reports that the Office of Population Affairs deals with family planning, teenage pregnancy, and adoption.
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Bader submitted a request through the Freedom of Information Act (FOIA) to the FDA for communications between the FDA and HHS regarding the drafting of content for the "Gender-Affirming Care and Young People" document. When the FDA and HHS failed to comply with the legal deadline (20 days after submitting the request), Bader filed a lawsuit through the Bader Family Foundation, which forced the FDA to respond to his FOIA request.
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Writing for Liberty Unyielding, Bader stated that on August 9, 2022, the FDA issued its response, declaring, "A search of the Covered FDA offices did not locate responsive records; therefore, we have no documents to provide you."
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"FDA would have such records if the Office of Population Affairs or HHS had sent drafts of the 'Gender-Affirming Care and Young People' document to experts at the FDA for their review," said Bader. "But according to the letter sent to me by Meredith J. Schlaifer of FDA, no such records exist," he continued.
Bader quotes from former FDA official David Gortler's op-ed for Newsweek in May, which showed concern over the HHS's failure to consult with the FDA on promoting drugs that are being used off-label to treat minors with gender dysphoria. "As a former senior executive FDA drug safety official, I have to wonder why my 20,000-plus former colleagues at the FDA are not speaking out after being circumvented on transgender clinical pharmacology recommendations by an obscure, obviously unqualified HHS office," announced Gortler.