But because the site sells unapproved versions of the drugs outside of REMS, the FDA is going after it — part of a broader crackdown on online illegal drug sales. “We’ve been very active in combating illegal online sales of unapproved medicine,” an agency spokesperson told Vox. “This is not about the particular product. This is business as usual for FDA.”
Reproductive rights activists, however, view the crackdown slightly differently: as another move that’ll make it harder for patients to have a safe abortion. “As access to clinic-based abortion care becomes more constrained because of legal restrictions, more women may turn to these websites as they look for options to end an unwanted pregnancy,” said Daniel Grossman, a professor in the department of obstetrics, gynecology, and reproductive sciences at UCSF.
Instead of going after these websites, Grossman continued, the FDA “might better use its resources to explore how the medically unnecessary restrictions” on the drugs — through the risk mitigation program — “could be lessened in order to improve access to safe abortion care.”
Women in the US have faced arrest and jail time for self-managed abortions
Although abortion is still legal in the US, self-managed abortions have been considered criminal in many states, and people have in rare cases faced arrests, jail time, or police investigation.
“Many think it’s easy to get an abortion in the US, but it is not,” Jill Adams, the strategy director for the SIA Legal Team, a group of lawyers focused on self-managed abortions, told Vox in October. “Resourceful people are looking for options to end a pregnancy that are safe, affordable, and fit their circumstances.” (Gomperts said she’d filled 600 US prescriptions in six months last year.)
Getting an abortion by mail from Aid Access works like this: Patients are screened through an online consultation about their pregnancy and health history. If they meet specific criteria — healthy, less than 10 weeks pregnant, live within one hour of a hospital — Gomperts fills a prescription and sends it to a pharmacy in India she knows and trusts.
The pills are then mailed from India to the woman’s home for a fee of $95 (though Aid Access says it will find ways to help patients who can’t pay). And patients can access real-time instructions and support if necessary.
The two medications Gomperts prescribes — again, mifepristone and misoprostol — work in combination by inducing a miscarriage early on in pregnancy. These drugs are considered essential medicines by the World Health Organization, meaning they’re supposed to be available to people in all functioning health systems at all times.
If taken before 10 weeks, mifepristone and misoprostol are 92 to 98 percent effective. So failed abortion is rare when patients use these drugs as directed, according to UpToDate, the physician’s evidence-based medicine resource.
The Aid Access approach has been shown to be safe — but it’s not risk-free. And we know much less about Rablon.
The WHO has also studied the safety of using mifepristone and misoprostol when self-administered at home compared to in a clinic, and gave the home-based approach the green light. “There is no evidence that home-based medical abortion is less effective, safe or acceptable than clinic-based medical abortion,” the WHO report concluded.
Reproductive medicine experts in the US also consider these drugs reliable and routine. “First-trimester medication abortion with mifepristone and misoprostol is very safe,” said Grossman, “with serious complications occurring in less than 0.5 percent of patients.”
But this doesn’t mean anyone who’s pregnant can take these drugs — or that the pills are risk-free. According to UpToDate, there are a number of groups that should avoid mifepristone and misoprostol, including those with ectopic pregnancies (or pregnancy that grows outside the womb, which can only be confirmed by getting medical imaging), those with an intrauterine device in place, and those who have chronic adrenal failure or who are on long-term corticosteroid therapy.