Redeem now - Testosterone, a controlled substance, couldn't be prescribed virtually before the COVID-19 pandemic.
- Loosened regulations during the pandemic have allowed telehealth companies to prescribe it online.
- This could change soon, and some telehealth companies are working on backup plans.
Kole, a game developer in Colorado, gets his testosterone therapy through Folx Health, a startup that conducts doctor visits online and sends him his medication through the mail.
This story is available exclusively to Business Insider subscribers. Become an Insider and start reading now. Have an account? Log in.Kole says he likes using Folx because he can avoid in-person clinics. He told Insider the privacy of using a company like Folx made getting testosterone safer.
"That privacy is very liberating, actually, because I'm not in fear of someone hating who I am, finding out where I live or finding out what I drive, and lashing out at me," said Kole, who pays $140 a month for access to Folx's online services. Insider agreed to identify him by only his first name to protect his safety.
It could become more difficult to get hormone therapy online
Several hundred thousand people use testosterone for gender-affirming hormone therapy, according to an estimate from the Center for Applied Transgender Studies. For many, this care, which is used to help some transgender people feel more like their true gender, is a crucial and often life-saving treatment that can increase happiness and decrease feelings of depression and anxiety. For thousands of people like Kole, who get their testosterone treatments online, this convenient, safe access may be at risk if rules around telehealth return to a pre-pandemic status quo.
The Drug Enforcement Administration classifies testosterone as a controlled substance, and before the COVID-19 pandemic it was impossible to get it solely through telehealth. In response to the pandemic, the DEA loosened regulations, making it easier to get controlled substances like testosterone and the ADHD drug Adderall online.
The order that allowed for these looser regulations is set to expire on October 13, though it's been extended repeatedly, and many expect the Biden administration to extend it yet again. Still, President Joe Biden's recent declaration that the pandemic was "over" is the latest sign that COVID-era flexibility won't last forever. And telehealth companies that offer treatments like testosterone are working to come up with contingency plans.
Folx and Plume are two of the most prominent startups providing direct-to-consumer gender-affirming hormone therapy. Folx estimates it has 5,000 clients on testosterone, and Plume estimates that 30% to 40% of its 11,000 users are on testosterone.
In-person doctor visits could become necessary to get testosterone
Plume, which is based in Denver, said it's working on contingency plans but declined to describe them to Insider. Plume was founded by Jerrica Kirkley and Matthew Wetschler in 2019 to provide gender-affirming hormone therapy over telehealth. The company has raised $41 million.
Folx said its contingency plans involved sending patients to in-person clinics. One option would be for patients to be seen by a Folx clinician remotely from a clinic run by a provider with the ability to prescribe controlled substances. Another would be for the patient to see their Folx provider in person. Folx could also refer patients for in-person care to doctors not associated with the company.
Certain policy developments could let Folx and Plume keep prescribing testosterone, though, and two senators have asked the Biden administration to loosen restrictions on the treatment. Plume and Folx said they're urging lawmakers to continue to allow online prescribing of hormone therapy.
The DEA is working on a plan to allow doctors to prescribe controlled drugs online
The DEA is required by law to come up with a way to allow doctors to continue prescribing controlled substances via telehealth. While that plan has been delayed for more than a decade, the DEA put out a proposal in March, and a top Folx executive said the DEA was facing added pressure to finalize the plan because so many patients got their care online.
A DEA representative declined to say how long it might take to finalize the rule.
The Folx executive, the company's chief clinical officer, Kate Steinle, said the startup expected to be allowed to continue prescribing testosterone under this rule change. Folx, which is based in Boston, was founded in 2020 to provide telehealth services to LGBTQ communities. Folx has raised almost $25 million.
"Now if the public-health emergency stopped and there wasn't any ability to continue prescribing through telehealth, it literally drops people who had been accessing this care for telehealth completely," Steinle told Insider.
Kole began using Folx for his testosterone prescription after leaving Texas, where he didn't try to get a prescription because he felt he wouldn't be able to get the care he needed. He said he left the state over safety concerns stemming from rising anti-trans sentiment, exacerbated by Gov. Greg Abbott's recent attacks on care for trans youth.
He said he understood that DEA rules might return to what they were before the pandemic but didn't expect there to be an interruption to his prescription.
"I'm not actually going to worry," he told Insider, "until Folx gives me something to worry about."
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