Transgender and gender-expansive people in the U.S. face a variety of barriers to accessing the health care they need. Transgender men or gender-expansive people of masculine experience (whom we will refer to collectively as transmasculine people, although we recognize people of many identities undergo gender affirming hormone therapy) frequently face an additional barrier: access to testosterone. Unlike other hormones that are used for gender-affirming hormone therapy (GAHT) for transgender and non-binary people, testosterone is a controlled substance in the U.S., which means that it is more tightly regulated than other medications, including other hormone medications such as estrogen and progesterone. The status of testosterone as a controlled substance exacerbates access to care for many transmasculine individuals.
People of all genders produce testosterone. Not every individual who takes testosterone identifies as transgender, and not every person who is transgender receives GAHT. For transmasculine people, GAHT via testosterone is an effective treatment option and an important part of gender-affirming medical treatment that improves their overall health. With the assistance of a qualified provider, GAHT is safe and effective to alleviate gender dysphoria that often derives from certain secondary sex characteristics.
While testosterone impacts people’s bodies differently, common effects facilitate body hair growth, deepening of the voice, redistribution of and/or increases in weight and muscle mass in the face and body, as well as cessation of the menstrual cycle. These effects can be highly affirming and successful in alleviating gender dysphoria. Testosterone comes in many forms, including injections, gels, patches, pills, and pellets inserted under the skin. While some people go on and off testosterone, patients must consistently take it in order to maintain its effects. Prescribing physicians monitor a patient’s testosterone level so it reaches the equivalent concentration in cisgender males. However, some transmasculine individuals only desire a minimal dosage of testosterone, too. It is important to note that people of all genders have a wide and diverse range of testosterone levels. The impact of testosterone has shown significant improvements in quality of life and reductions in mental health conditions, like anxiety and depression.
Synthetic testosterone was first synthesized in 1935. It qualifies as a steroid, and has been used for therapeutic and aesthetic reasons, as well as to enhance athletic performance. It is largely due to these second two uses that testosterone is tightly regulated in the United States. While performance-enhancing drugs were banned from the Olympics from the 1968 Games onward, many of these substances, including testosterone, were available in the U.S. to anyone as long as their use was prescribed by a doctor. By the 1980s, however, Ronald Reagan had announced a “War on Drugs,” and the media was covering more stories about athletes using testosterone and other steroids to enhance their performance, often relying on illicit products, or doctors’ bending the rules to prescribe these drugs. In 1988, public concern about the use of steroids for athletic enhancement was on the front page when Canadian sprinter Ben Johnson was stripped of his gold medal for the 100 meter dash after failing a drug test.
Eventually, concerns about the misuse of testosterone and other steroids led Congress to first regulate the drug through the Anabolic Steroid Act of 1990. The law was opposed by the FDA, DEA, and even the American Medical Association, because of the lack of evidence that steroid use resulted in dependence. This law identified anabolic steroids as a separate drug class that was added to Schedule III of the Controlled Substances Act. It categorized over two dozen drugs, including testosterone, to fall in the new class of anabolic steroids. Thus, testosterone became classified as a Schedule III controlled substance, subjecting the medication to heightened regulation beyond the typical prescription drug.
Regulating testosterone is complicated in the context of biology, fairness, and gender identity, particularly because everyone produces it. Strict regulation and criminalization over testosterone has contributed to harmful narratives about gender where testosterone is the scapegoat for “advantages” and violence. This comes up often within the realm of competitive sports. In 2020, South African runner and Olympian, Caster Semenya who is also intersex with naturally elevated testosterone levels, was barred from competing unless she took medication to suppress her natural testosterone levels. This kind of policing is not unusual, especially given the number of legislative efforts across the U.S. to prevent transgender youth from competing in sports.
These harmful narratives contribute to widespread misinformation, including in the medical field where studies are largely inconclusive about the correlation between testosterone and aggression in transgender people. Some people delay or forgo undergoing gender affirming hormone therapy out of a misinformed fear that it will “change” their personalities and make them more prone to violence. Prescribing doctors often incorrectly advise patients that they cannot get pregnant while on testosterone and/or that it will make them infertile. Providers often fail to have open conversations with transgender patients about family planning and their options, which can include fertility preservation or temporarily pausing gender affirming hormone treatment to become pregnant.
Testosterone’s status as a Schedule III controlled substance means it is more strictly regulated than other prescription drugs, even other synthetic hormones. Specifically, prescriptions are only good for six months, resulting in people who use testosterone needing frequent contact with their prescribing provider to ensure a consistent supply of the drug. While a prescription is good for six months, states and health plans may impose additional restrictions. For example, many people in Medicaid and private coverage can only fill their prescription for 30 days at a time, requiring monthly pharmacy visits. During the pandemic temporary rule changes due to COVID allowed many people to obtain 100-day supplies of their prescriptions and have them mailed to their doorsteps. However, drugs like testosterone are often excluded from these changes because of their classification as a controlled substance.
The requirements to obtain the drug in person and obtain a new prescription every six months compound other barriers to access, including gatekeeping. While most clinicians do not recommend that people receive therapy or counselling before obtaining a prescription for hormone treatment, many providers will not write a prescription for testosterone unless the person undergoes some form of mental health treatment first, which can delay access to care (usually for youth seeking gender affirming hormone therapy). Further, some physicians discriminate against transgender people and are not willing to prescribe testosterone for transmasculine people, which can interrupt a gender-affirming treatment plan that requires consistent access to the drug. At the same time, consistent access is important to alleviate symptoms associated with gender dysphoria, and abruptly stopping the drug can cause serious side effects. In the last several years, the U.S. has experienced several testosterone shortages, which has exacerbated these factors and posed additional barriers to care for transmasculine people. Notably, states may impose additional limitations on scheduled substances beyond the federal limitations.
Some advocates have suggested that testosterone could remain a Schedule III substance, but could have the parameters for its use changed such that it could be sold in limited quantities over-the-counter upon a showing of appropriate ID. While such a change would eliminate the need for transmasculine people to regularly see a health care provider to obtain this critically important gender-affirming treatment, it could also make treatment more expensive, since most health coverage programs and insurance are not required to–and do not–cover over-the-counter medications. Thus, this change could simply replace one barrier to care with another.
Perhaps the most straightforward solution to ensure that transmasculine people have access to gender-affirming testosterone would be to remove it from the Controlled Substances schedule completely. Removing drugs from the Controlled Substances schedule is extremely rare, in part because it could implicate the U.S.’s participation in certain international treaties. In any event, given concerns about testosterone misuse for cosmetic and athletic performance enhancement purposes, such a change is unlikely. Another option is to move testosterone to a less restrictive tier on the Controlled Substances schedule. This could be accomplished through action by Congress, the Drug Enforcement Administration or the Department of Justice. In this case, testosterone could be moved to Schedule V, which is the tier where drugs least susceptible to misuse — such as cough medications with codeine — are placed. Drugs on Schedule V are not subject to any federal limits on prescriptions and refills, but must be registered and securely stored to allow for greater monitoring of their use. Finally, without a change to testosterone’s Schedule III status, states can authorize pharmacists to prescribe testosterone, which could eliminate the need for regular interaction with other healthcare providers, and make testosterone more readily available, since pharmacies are often more accessible than other health care providers.
Advocates should support transmasculine people by working for policies that make testosterone more accessible to them.