Former Health Officials Criticize FDA on Puberty Blockers

Former officials from the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) have expressed strong disapproval of the FDA's approach to off-label use of puberty blockers. They argue that the agency has been inconsistent, allowing these treatments while simultaneously condemning safer alternatives for COVID-19. Brian Harrison, a former HHS chief of staff and current Texas state representative, highlighted the media's silence on the FDA's actions under the Biden administration, contrasting it with the scrutiny faced during the Trump era. In a 2022 email, Shannon Sullivan, a clinical team leader at the FDA, revealed that the agency had conducted a safety review of GnRH agonists, which are used to block puberty by inhibiting the release of sex hormones. The review focused on potential risks such as suicidal thoughts, seizures, and bone health. Sullivan noted that no pharmaceutical company had yet approached the FDA regarding the use of these drugs in transgender youth. Dr. Gortler, a former FDA adviser, criticized the agency for its perceived duplicity in evaluating adverse event reports. He pointed out that while the FDA deemed hydroxychloroquine unsafe based on a few hundred reports, it has largely dismissed a significantly higher number of adverse reports related to GnRH agonists, which total around 70,000. Gortler emphasized that these drugs were originally developed for cancer treatment, raising concerns about their application in younger populations. The FDA has not responded to requests for comment regarding these allegations.