Text of the Letter (PDF) 

Washington (September 16, 2022) ­– Senator Edward J. Markey (D-Mass.) led a letter to the U.S. Department of Justice (DOJ), the U.S. Department of Health and Human Services (HHS), and the U.S. Drug Enforcement Administration (DEA) urging the Biden administration to consider rescheduling or descheduling testosterone in order to make this gender-affirming hormone therapy more accessible to transgender people, including transgender men and transmasculine nonbinary people. Testosterone, a masculinizing hormone therapy, is prescribed to raise testosterone and suppress estrogen levels, causing physical changes such as suppressed menstruation, decreased estrogen production, deepened voices, and increased facial hair growth. The letter was also signed by Senator Elizabeth Warren (D-Mass.).

In 1990, Congress added testosterone to the Controlled Substances Act as a Schedule III substance – the class of substances which “may lead to moderate or low physical dependence or high psychological dependence” – amid concerns that amateur and professional athletes were using it and other steroids. But Congress’s response more than 30 years ago to testosterone’s non-medical use by athletes has inadvertently created health and criminal justice barriers to gender-affirming care today. Currently, testosterone’s status as a Schedule III controlled substance prevents prescriptions for testosterone from being filled or refilled six months after issuance, or being refilled more than five times. On top of these requirements, states and private health insurers may impose further restrictions, such as 30-day limitations on controlled substances or limitations on mail delivery of prescriptions. Furthermore, testosterone’s Schedule III status can limit the number of trans-friendly providers available due to DEA licensing requirements for controlled substances, limit access via telemedicine, and drive illicit use of unregulated hormones. Finally, its status has played a role in the criminalization, discrimination, and harassment of transgender people through Prescription Drug Monitoring Programs (PDMPs), state-level electronic databases that monitor a wide range of controlled substances including opioids and testosterone. These programs may “out” transgender people to their medical providers, pharmacists, family members, and other people and agencies with access to these databases.

Rescheduling testosterone from a Schedule III to a Schedule V substance would put testosterone in the class of substances with low potential for abuse. Alternatively, descheduling testosterone would remove it from the Controlled Substances Act entirely. Estrogen, the feminizing hormone therapy, is not a controlled substance.

“Testosterone’s Schedule III status adds barriers to medically necessary, gender-affirming care while leaving transgender people vulnerable to harassment, discrimination, and surveillance,” wrote the Senators in their letter. “Rescheduling or descheduling testosterone would further the goals and policies already announced by the White House and HHS. We applaud the Administration’s ongoing efforts to support the transgender community’s access to health, including strengthening Section 1557 non-discrimination rule-making and working with states on expanding access to gender-affirming care.”

“We believe that descheduling or rescheduling testosterone is an important and necessary step to expand access to gender-affirming, life-saving care,” the letter concluded.

In addition to urging the officials to deschedule testosterone or reschedule the hormone as a Schedule V controlled substance, the Senators requested answers to the following questions by October 7th:

  • What steps, if any, have the DOJ, HHS, and DEA taken to begin reconsideration of testosterone’s Schedule III status?
    • Has DOJ, HHS, or DEA met with any representatives of the transgender community about testosterone access issues related to its Schedule III status? If so, who and when? If not, why not?
    • Has DOJ, HHS, or DEA met with any representatives of the medical community, about testosterone access issues related to its Schedule III status? If so, who and when? If not, why not?
  • What consideration has the Administration given to rescheduling or descheduling testosterone as part of its efforts to promote LGBTQ equality as reflected in the June 15th Executive Order?
    • If the Administration has not already considered rescheduling or descheduling testosterone, will it now include testosterone access in future considerations and recommendations? If not, why not?
  • Has the DEA taken any steps to protect the health, safety, and privacy of transgender men whose prescriptions for testosterone are reported to a Prescription Drug Monitoring Programs (PDMP)? If so, what steps has DEA taken? If not, why not?