WoLF Joined By International Coalition in Demanding FDA Address Off-Label Use of Puberty Blockers in Children

Apr 17

On Tuesday, WoLF joined over fifty clinicians and researchers in ten different countries and multiple organizations in demanding that the Food and Drug Administration (FDA) take action against the off-label use of puberty blockers in children.

Recent developments make it urgent that federal regulators take decisive action to protect vulnerable children. These developments include multiple international health bodies acknowledging the lack of evidence supporting pediatric interventions to modify sex traits, a scientific review of literature supporting a possible adverse effect of puberty blockers on IQ, and the release of a damning report disclosing additional lifelong harm from these potent drugs.

But while UK regulators commissioned the devastating Cass Review and there is a growing international consensus that no child should be chemically deprived of a normal puberty, in the United States, federal officials have not only refused to critically examine the continued off-label use in children of potent drugs of unproven efficacy—some officials, like Assistant Secretary for Health and Human Services Levine, have actively endorsed it.

Tuesday’s filing is an update to a Citizen Petition filed with the FDA on September 2, 2023, demanding that the FDA:

Commission a systematic review by the National Academy of Sciences, Engineering, and Medicine (NASEM) of the evidence concerning the off-label use of puberty blockers to treat “gender dysphoria” in children.
Issue written requests under the Best Pharmaceuticals for Children Act (BPCA) for long term registry studies of this off-label use.
Create a dedicated web page concerning this off-label use.
Alert manufacturers and providers to the consequences of unlawful promotions of this off-label use.