Texas investigates ‘off-label’ use of puberty blockers amid ongoing fight over transgender care

Texas Attorney General Ken Paxton is investigating two pharmaceutical companies to determine whether they marketed certain drugs to treat transgender youth experiencing gender dysphoria. On Thursday, Paxton demanded that AbbVie and Endo Pharmaceuticals produce a range of documents, communication and other information “related to the marketing and promotion of hormone blockers in Texas” by April 14. The attorney general tapped his authority under the Texas Deceptive Trade Practices to launch the investigation. At issue are Endo’s Supprelin LA and AbbVie’s Lupron Depot, drugs that federal regulators have approved to treat minors experiencing early puberty, but that are sometimes recommended by doctors “off label” to treat gender dysphoria. “Companies should never promote or supply puberty blockers for uses that are not intended or approved,” Paxton said in a statement. He first announced the investigation in December.

A representative with Endo Pharmaceuticals said it markets Supprelin LA to treat early puberty. “The Company does not promote its medications for off-label uses. That said, we intend to cooperate with this investigation,” Vice President for Corporate Affairs Heather Zoumas Lubeski said in a statement. According to the American Academy of Pediatrics, off-label use of drugs in pediatrics is a common practice because many drugs simply do not specify how they may be used to treat children. The term “off-label,” the AAP said in a 2014 policy statement, does not imply the drug is being improperly or illegally used; treatment decisions should come down to best available evidence and the benefit to the patient. Paxton is making the demand of these drug companies a month after he classified gender affirming medical treatments including blockers and hormone therapy as “child abuse” under state law. The state has opened at least nine investigations into allegations children are receiving such care since then. One of the families under investigation sued the state and secured an injunction halting the policy while it’s being litigated. Paxton is appealing that decision. Gender dysphoria is the feeling of discomfort or distress that can occur in people who identify as a gender that is different from the gender or sex assigned at birth, according to the Mayo Clinic. Not all transgender people experience dysphoria, and not all seek medical treatment.