Folx Health and Plume Prepare for Tighter Regulation of Online Testosterone

Folx Health and Plume Prepare for Tighter Regulation of Online Testosterone

  • Testosterone, a controlled substance, was virtually unprescribable before the COVID-19 pandemic.
  • Relaxed regulations during the pandemic have allowed telehealth companies to prescribe it online.
  • This could change soon and some telehealth companies are working on alternative plans.

Kole, a game developer in Colorado, gets his testosterone therapy through Folx Health, a startup that conducts online doctor visits and mails his medications.

Kole says he likes using Folx because he can avoid in-person clinics. He told Insider that the privacy of using a company like Folx made getting testosterone safer.

“That privacy is very liberating, actually, because I’m not afraid that someone will hate me, find out where I live or what I drive and attack me,” said Kole, who pays $140 a month. to access Folx online services. Insider agreed to identify him only by his first name to protect his safety.

A photo of Kole's head in a red shirt and glasses.

A game developer named Kole says he prefers to get attention online.

Courtesy Kole


It could get harder 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 and secure access may be at risk if rules around telehealth return to the pre-pandemic status quo.

The Drug Enforcement Administration classifies testosterone as a controlled substance, and prior to the COVID-19 pandemic it was impossible to obtain through telehealth alone. In response to the pandemic, the DEA relaxed regulations, making it easier to obtain 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 has been extended repeatedly, with many hoping the Biden administration will extend it once more. Still, President Joe Biden’s recent declaration that the pandemic was “over” is the latest sign that the flexibility of the COVID era won’t last forever. And telehealth companies offering 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 that he has 5,000 testosterone customers, and Plume estimates that 30-40% of his 11,000 users use testosterone.

In-Person Doctor Visits Might Be Necessary to Get Testosterone

Denver-based Plume said she is 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 instead of telehealth. The company has raised $41 million.

Jerrica Kirkley and Matthew Wetschler are the co-founders of Plume.

Jerrica Kirkley and Matthew Wetschler founded Plume.

Plume


Folx said his contingency plans involved sending patients to clinics in person. One option would be for patients to be seen by a Folx doctor 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 may also refer patients for in-person care to physicians not associated with the company.

However, certain policy developments could allow Folx and Plume to continue prescribing testosterone, and two senators have called on the Biden administration to loosen restrictions on the treatment. Plume and Folx said they are urging lawmakers to continue to allow online prescription of hormone therapy.

The DEA is working on a plan to allow doctors to prescribe controlled drugs online

The law requires the DEA to find a way to allow doctors to continue prescribing controlled substances through telehealth. While that plan was delayed for more than a decade, the DEA submitted a proposal in March, and a top Folx executive said the DEA faced additional pressure to finalize the plan because so many patients received their care online.

A DEA representative declined to say how long it might take to finalize the rule.

Folx executive, the company’s chief clinical officer, Kate Steinle, said it was hoped the startup would be able to continue prescribing testosterone under this rule change. Boston-based Folx was founded in 2020 to provide telehealth services to LGBTQ communities. Folx has raised nearly $25 million.

General Director of Folx, Liana Douillet Guzmán

The executive director of Folx, Liana Douillet Guzmán.

folx health


“Now, if the public health emergency were to stop and there was no chance to continue prescribing via telehealth, it would literally completely wipe out people who had been accessing this care for telehealth,” 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. She said she left the state over safety concerns stemming from growing anti-trans sentiment, exacerbated by Gov. Greg Abbott’s recent attacks on caring for trans youth.

He said he understood DEA rules could go back to what they were before the pandemic, but he didn’t expect there would be a break in his prescription.

“I’m not really going to worry,” he told Insider, “until Folx gives me something to worry about.”

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