New York City now has more than 700 confirmed cases of monkeypox, an orthopox virus similar to smallpox, and Dr. Radix is one of a chorus of health-care providers saying the barrier to access TPOXX is far too high. While most drugs require a prescription and a trip to the pharmacy, TPOXX is not commercially available, which means all prescribers must go through the federal government to acquire it from the Strategic National Stockpile. Because the Food and Drug Administration approved TPOXX for use against smallpox, the antiviral can be prescribed for off-label use only if the prescriber and patient adhere to a strict, cumbersome protocol. In order to get the drug, health-care providers must contact state or local health departments or the CDC. To do so, prescribers need to submit detailed information on each patient to the FDA and the CDC. The folio must include photographs of the patient’s lesions, the prescriber’s resume, and a daily journal kept by the patient once they’ve received the medecine. Additionally, all patients must undergo formal consent procedures. The paperwork is entirely in English and, Dr. Radix said, it forces trans and nonbinary patients to choose between checking the “male” or “female” box. All told, providers estimated that each TPOXX prescription required two to four hours of paperwork.

“I just can’t imagine every provider would have the willingness or the capacity to be able to do this,” said Lindsey Dawson, director of LGBTQ+ health policy at Kaiser Family Foundation. “There are levers that the CDC or FDA could use to streamline the process, and it’s our understanding that the federal government is working on doing that.”