For nearly two years, drug manufacturers have not been able to meet demand for injectable estrogen, which is a commonly prescribed hormone therapy for transgender women. A policy brief released today by The Fenway Institute, Callen-Lorde Community Health Center, and Treatment Action Group (TAG) describes the shortage as a “public health crisis” and urges the U.S. Food and Drug Administration (FDA) to be more proactive in seeking to resolve the crisis.
“Hormone therapy is life-saving for many transgender individuals and the current shortage of injectable estrogen violates transgender individuals’ right to comprehensive medical treatment that is free of discrimination,” said Sophia Geffen, one of the authors of the report, titled Resolving the current injectable estrogen shortage: A public health imperative. “The shortage of medicine is a public health crisis, as patients are forced to alter their regimen or may turn to black market sources of injectable estrogen, which is often diluted with other potentially harmful ingredients.”
The FDA drug shortages list merely provides a broad explanation of the reason for the shortage and an estimated release date. Consumers are not provided any information regarding what is required in order for the shortage to be resolved, and reported release dates are posted and then repeatedly not met. It is unclear if the release is being delayed by the pharmaceutical company or by the FDA, and the release date has been pushed back nearly every month for the past several months. One of the makers of injectable estrogen, Par Pharmaceutical, told Out magazine that the company had switched one of its suppliers for Delestrogen, which is the brand name for estrogen, but needs FDA approval before it can distribute the new formula. In response to a request to Par Pharmaceutical for information about the drug shortage, Par Pharmaceutical President Paul Campanelli told the authors of the issue briefthat a new raw material in Delestrogen requires FDA approval and that he estimated that the approval would be granted by early 2017.
Injectable estrogen comes in 40 mg/mL, 20 mg/mL, and 10mg/mL dosages. The 40 mg/mL formulation of injectable estrogen is the most frequently prescribed dose, and has been out of stock the longest. Healthcare providers have tried to work around the shortage by having patients take two doses of the 20 mg/mL formula, or four doses of the 10 mg/mL formula. As of this writing, however, all formulations of injectable estrogen, which is often preferred by patients, are unavailable. As a result, healthcare providers are dramatically changing the treatment regimens of their patients, some of whom have been using injectable estrogen for more than a decade.
The lack of transparency for the drug shortage has made it even more difficult for transgender individuals, who report some of the highest rates of discrimination in health care settings, to access quality health care. The policy brief argues that the FDA “should not merely reiterate vague, manufacturer-provided information regarding drug shortages and delays” and its authors urge the FDA to be more proactive in seeking information from manufacturers in order to keep the public informed.
The brief also argues that there is a lack of evidence-based practice regarding hormone therapy for gender affirmation. Health care providers, working closely with transgender patients and advocates, have created feminizing hormone therapy treatments that result in the development of female secondary sex characteristics, such as breasts, while suppressing male secondary sex characteristics, such as muscle mass. Estrogen prescribed for feminizing therapy is commonly delivered through a patch, oral or sublingual tablet, or injection. However, no studies have compared the benefits or risks of varying estrogen delivery methods for transgender women. By contrast, there are over 17 estrogen medications with approved FDA labels for menopausal women. The FDA could―and should―use existing regulatory frameworks to incentivize this research among manufacturers.
The authors of Resolving the current injectable estrogen shortage: A public health imperative encourage transgender health activists to submit public comment to the FDA on the issue by January 9, 2017. Comments can address the FDA’s role in agency-regulated approval of hormones for gender affirmation, and the FDA’s level of transparency around drug shortages. The public is also encouraged to contact the National Institute of Minority Health and Health Disparities (NIMHD) and urge the agency to develop clinical research priorities that strengthen the evidence base needed for clear regulatory guidance and transgender health best practices.
The policy brief Resolving the current injectable estrogen shortage: A public health imperative is available online here.
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