Take Action! Tell the FDA to Address Off-Label Use of Puberty Blockers in Children
Dangerous puberty blockers like Lupron are being prescribed to minors without FDA oversight - Act now to protect more children from harm!
A new petition by a coalition of physicians and organizations is calling on the FDA to take action in response to the growing and dangerous trend of the off-label use of puberty blockers in children to treat “gender dysphoria.” The public is able to submit comments in support of this petition.
View WoLF’s full comment here!
Take Action Now!
Use this form on the Federal Regulations Website to submit your comment for consideration. There is no minimum or maximum length. You may also submit attachments. Consider focusing your comment on the impact these drugs have on women and girls!
About the Petition
Who submitted the Petition?
The petition was submitted to the FDA on Sept. 1 by a group of thirteen physicians and organizations who are concerned about the current state of care for gender-distressed young people: Jay T. Allen, MD, Family Physician; Miriam Grossman, MD, Child and Adolescent Psychiatrist; Patrick Hunter, MD MSc, Pediatrician and Bioethicist; William Malone, MD, Endocrinologist; Quentin van Meter, MD, Pediatric Endocrinologist; Detrans Help, Foundation Against Intolerance and Racism (FAIR) in Medicine; Gender Dysphoria Alliance; Gender Exploratory Therapy Alliance; Genspect; International Partners for Ethical Care; Our Duty USA; and Rethink Identity Medicine Ethics.
What’s the problem with puberty blockers?
Puberty blockers are FDA-approved for certain uses but use as a treatment for gender dysphoria remains unapproved (or "off-label"). As you might expect, blocking the normal course of puberty has many serious known and potential risks to kids' health. Margot O’hlfearnain published an excellent piece on the WoLF web site in July, describing the growing medical scandal surrounding the use of Lupron—the most widely prescribed puberty blocker—in so-called gender medicine.
Gender ideologues not only misrepresent these risks but also make overblown claims about the benefits of puberty blockers in alleviating gender dysphoria. In fact, multiple reviews of scientific evidence by foreign health authorities have found the evidence supporting this use to be "poor." In other words, the medical establishment is casually subjecting children who are often emotionally troubled, same sex attracted, or both, to lifelong harms—including infertility—with unknown benefit. Or, as Helen Joyce has put it, "they're sterilizing gay kids."
What does the petition ask the FDA to do?
After decades of lobbying by the pharmaceutical industry, the FDA has very limited authority to curtail unapproved uses of drugs. What the FDA can do is correct the public record about the risks and benefits of these drugs.
The specific requests included in the petition are:
Commission a systematic review of this off-label use by the National Academy of Sciences, Engineering, and Medicine (NASEM).
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.
Will the FDA respond?
The FDA is under no official deadline to provide a final response to a Citizen Petition. In practice, the FDA rarely takes less than a year to respond and commonly takes several years. How the FDA responds—whether the FDA grants or denies the relief requested in the petition—depends on several things, including political considerations. The FDA reports to the Department of Health Human Services, which is headed by Secretary Becerra. Secretary Becerra and Assistant Secretary Levine are vocal advocates of the experimental use of puberty blockers in kids. But even if the FDA denies the petition, the FDA will have to provide a reason for the denial. The FDA's reasoning can be contested—in Congressional oversight and even in the courts.
But even under this administration, the FDA might grant the petition. As outrage grows about what the medical establishment is doing to kids, the administration may welcome an off-ramp. The petition's request of the FDA to commission the National Academy of Science, Engineering, and Medicine to conduct an independent review could provide just that—a way for the FDA to outsource decision-making on a politically charged subject. Whatever the outcome, it is likely that the FDA will defer decision-making until after the 2024 election.