Nancy Stade: 2023 anti-trans FDA petition

In 2023, American lawyer Nancy Stade prepared a petition submitted to the US Food and Drug Administration (FDA) seeking to ban off-label use of puberty-blocking drugs, which would affect trans and gender diverse minors.

Banning off-label use of puberty-blocking drugs is a key goal of anti-trans activists who want to stop young people from making a gender transition. Stade’s petition was signed by dozens of anti-trans activists and organizations.

Background

“Off-label” use refers to prescribing or using an FDA-approved drug in a way that hasn’t been specifically approved by FDA. This legal practice can include uses for:

• a different indication (such as a condition or disease for which the drug was not explicitly approved)
• a different patient population (such as use for gender diverse children)

FDA has not explicitly approved use of puberty blocking drugs for trans and gender diverse minors, but providers are legally allowed to prescribe them. Stade’s petition sought to make this practice illegal.

Citations

Stade’s petition (FDA-2023-P-3767) cites several publications by anti-trans individuals and organizations, including

• Hilary Cass and The Cass Review
• Society for Evidence-Based Gender Medicine website
• WHO Decides, a petition to the World Health Organization
• Sallie Baxendale
• Sarah C. J. Jorgensen
• Nicole Athéa
• Céline Masson
• The WPATH Files by Mia Hughes and Environmental Progress, an attack on WPATH
• WPATH SOC-8
• Genspect’s Stats for Gender site
• A PLOS-One article by Lisa Littman promoting “rapid-onset gender dysphoria”
• An International Journal of Transgenderism article by Kenneth Zucker on “the myth of persistence”
• A Journal of Sex and Marital Therapy article by Michael Biggs
• Two Journal of Sex and Marital Therapy articles by Zhenya Abbruzzese, Julia W. Mason, and Stephen B. Levine
• A Wall Street Journal editorial by 21 clinicians, including Riittakerttu Kaltiala, Richard Byng, Anna Hutchinson, Anastassis Spiliadis, Sven Román, Anne Wæhre, Patrik Vankrunkelsven, Celine Masson, Caroline Eliacheff, Stephen B. Levine, William Malone, Patrick K. Hunter
• A Wall Street Journal editorial by Roy Eappen and Ian Kingsbury
• A Wall Street Journal editorial by Gerald Posner
• A New York Times article by Azeen Ghorayshi
• A New York Times article by Meghan Twohey and Christina Jewett
• An Atlantic article by Frieda Klotz
• A Washington Free Beacon piece by Aaron Sibarium

Signatories

Individual signatories are listed by country, with a list of anti-trans organizations at the end. Names have been reordered alphabetically under each country.

Belgium

• Kristina Casteels, MD PhD
• Sophie Dechene, MD MRCPsych
• Beryl Koener, MD, PhD
• Robert Naeije, MD, PhD
• Patrik Vankrunkelsven, MD, PhD

Canada

• Sarah Jorgensen, PharmD PhD
• Leonora Regenstreif MD, CCFP(AM), FCFP
• Joanne Sinai, MD, MEd

Finland

• David Gyllenberg, MD, PhD
• Riittakerttu Kaltiala, MD, PhD, BSc
• Samuli I. Saarni, MD, PhD
• Laura Takala, MD PhD
• Katinka Tuisku, MD, PhD
• Marja Työläjärvi, MD

France

• Nicole Athéa, MD
• Anne-Laure Boch, MD PhD
• Caroline Eliacheff, MD
• Céline Masson, PhD, HDR

Norway

• Anne Waehre. MD PhD

South Africa

• Allan Donkin, MBChB
• Janet Giddy, MBChB, MFamMed, MPH

Sweden

• Giedre Griglioniene, MD PhD
• Sven Román, MD
• Christian Schmitt, MD

United Kingdom

• Dr David Bell, MRCP, FRCPsych
• Dr Katie Clyde, MBChB, DGM
• Lenny Cornwall MD FRCPsych
• Dr Nicky Cowan
• Jennie Cummings-Knight, MA Couns.
• Dr Az Hakeem, MBBS, MSc, FRCPsych
• Dr Chris Holdridge, BA, MBBS, AKC
• Dr Louise Irvine
• Dr Tessa Katz, BSC, MBChB, MRCGP
• Dr Ita Lyons MB BCh FRCPsych
• Dr Julie Maxwell, MBBCh, MRCPCH
• Dr Aileen O’Brien
• Stella O’Malley
• David Pilgrim MSc, MPsychol (Clin), PhD
• Dr Hannah Ryan, MBChB, MSc
• Dr Celia Sadie
• Dr Kiran Sharma, MBBS, MRCGP
• Dr Juliet Singer
• Stephen Westgarth, MBBS MRCPsych
• Bob Withers
• Dr Pamela Yerassimou, MB BCh

United States

• Miriam Grossman, MD
• Patrick Hunter, MD MSc
• William Malone, MD
• Carrie Mendoza, MD
• Quentin van Meter, MD

Organizations

• Clinical Advisory Network on Sex and Gender (CAN-SG)
• Detrans Help
• FAIR in Medicine
• Gender Dysphoria Alliance
• Genspect
• Genspect, USA
• International Partners for Ethical Care (PEC)
• Our Duty, USA
• Therapy First (formerly Gender Exploratory Therapy Association)
• Themis Resource Fund
• Women’s Declaration International USA (WDI USA)
• Women’s Liberation Front (WoLF)

References

Stade, Nancy K. (September 4, 2023). Citizen Petition from Nancy K. Stade et. al. https://www.regulations.gov/document/FDA-2023-P-3767-0001

• Supplement to Citizen Petition from Nancy Stade et al. (April 16, 2024) https://www.regulations.gov/document/FDA-2023-P-3767-0654
• Acknowledgment Letter from FDA DMS to Nancy K. Stade et al. (September 5, 2023). https://www.regulations.gov/document/FDA-2023-P-3767-0002
• Citizen Petition Seeking FDA Action on Off-Label Use of Puberty Blockers – correction to page 11-5 (Septmber 8, 2023). https://www.regulations.gov/document/FDA-2023-P-3767-0029
• Addendum to Supplement filed on April 15, 2024 from Nancy Stade et al. (May 14, 2024). https://www.regulations.gov/document/FDA-2023-P-3767-0720