Good morning, Broadsheet readers! Moms are at the forefront of advocating for tech accountability, fewer women in India are working despite the rising population, and abortion pill startups Hey Jane and Choix contend with the legal battle over mifepristone. Take care this Tuesday!
- A hard pill. Two startups providing easy-access abortion pills are considering how they may need to alter their business models after Friday’s dueling rulings on the Food and Drug Administration’s approval of mifepristone, a drug commonly used in medical abortions.
On Friday, Judge Matthew J. Kacsmaryk of the northern Texas U.S. district invalidated FDA approval of mifepristone, siding with anti-abortion groups and doctors who claimed in a November lawsuit that the FDA didn't do enough research to prove mifepristone is safe and effective. (He stayed his decision for seven days to allow for appeals; mifepristone remains on the market.) The FDA has disputed the argument, saying it has continuously reviewed the drug since granting initial approval more than 20 years ago.
That same day, a Washington State judge issued an injunction ordering the FDA to take no action that would further restrict access to mifepristone. The competing rulings will likely land the matter before the Supreme Court.
Mifepristone, paired with another drug called misoprostol, is a common prescription regimen for medical abortions, which account for more than half of all abortions in the U.S. In recent years, demand for the pills has spawned several startups that must now contend with the contradictory rulings and a potential Supreme Court decision that could yank mifepristone from the market, upending their business models.
Initially, the Texas case seemed far-fetched to Choix CEO and founder Cindy Adam, a former nurse practitioner who launched the abortion pill startup in 2019. But conversations with abortion access activism groups made her realize that the lawsuit could force Choix to change its offerings.
Last fall, Choix began offering "advance provision" pills—doses of mifepristone and misoprostol intended for future use. As awareness of the Texas lawsuit increased, so did customer uptake for this option. A quarter of all advance provision sales occurred in February after an early hearing in the trial. Choix is still offering the two-drug protocol today but is preparing to move to a misoprostol-only regimen should courts ultimately side with the anti-abortion groups.
However, that switch carries consequences for both the patient and the company.
Using only misoprostol is still effective, but takes longer and often causes more gastrointestinal issues for patients.
“While (misoprostol-only) is an option, it is not the best option. It's not the most effective option. And it's not what patients need and deserve, given that they have this other option,” Adam says.
The misoprostol-only protocol will cost Choix less, but the startup must keep the price for patients the same as the two-drug regimen to offset additional costs providers will incur as they swap the drugs, Adam says. In the future, Adam will cut the cost to reflect the lower cost of misoprostol, she says.
Kiki Freedman, cofounder and CEO of abortion pill startup Hey Jane, was originally planning to switch to misoprostol only if the Texas decision favored anti-abortion groups. But as the case dragged on, the company said on Twitter it would continue to provide the two-drug regimen until the FDA told it otherwise.
Founded in 2021, Hey Jane has experienced rapid growth since the Dobbs decision overturned Roe v. Wade last year. It has expanded its services to Connecticut and New Jersey and now provides abortion pills by mail to eight states. Hey Jane's monthly patients have increased 110% since Dobbs, Freedman says.
She won’t speculate on what the Supreme Court might do and how Hey Jane will respond. With an appeal of the Texas ruling already filed in the 5th Circuit and senior executives at more than 250 pharmaceutical and biotech companies condemning the ruling, both founders remain hopeful that science will prevail.
“This ruling and the case, in general, was a pretty clear indication of the ongoing efforts of anti-choice folks to go beyond Dobbs…The goal is clearly not limited to leaving it up to the states,” says Freedman. “We will keep doing everything we can to keep providing that safe and effective care.”
Kinsey Crowley (she/her)
kinsey.crowley@fortune.com
@kinseycrowley
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