The agency sent warning letters to two web retailers selling the medical abortion pills misoprostol and mifepristone.
The US Food and Drug Administration is cracking down on organizations that sell medical abortion pills over the internet.
In a warning letter released Tuesday, the agency requested that the online abortion pill provider AidAccess.org immediately stop selling unapproved versions of the abortion drugs mifepristone and misoprostol and respond to FDA concerns within 15 working days outlining how it will correct its regulatory violations.
“Failure to [do so] may result in FDA regulatory action, including seizure or injunction, without further notice,” an agency spokesperson told Vox.
The FDA also issued a warning letter to Rablon, an online pharmacy network that includes at least 87 websites, such as AbortionPillRx.com and AbortPregnancy.com, directly selling mifepristone and misoprostol to patients.
Legal versions of mifepristone and misoprostol have been available to patients in the US since 2000 — but patients can’t just get them at any pharmacy. The drugs are only given out by certified health care providers in a doctor’s office, clinic, or hospital. The providers need to sign a waiver that they’ll ensure patients have access to a surgical abortion or emergency care if anything goes wrong — part of an FDA risk mitigation program called REMS, which is common to higher-risk medications.
When retailers sell unapproved versions of drugs outside of the REMS program — which the FDA says Aid Access and Rablon have — “FDA is well within its regulatory authority to take action,” said Tim Mackey, a UC San Diego School of Medicine expert on counterfeit drugs. (In the case of Aid Access, the pills are imported from India.)
But reproductive rights groups and doctors have long viewed REMS as a “medically unnecessary” barrier to women who want access to a safe abortion. And Aid Access, which was started by the Dutch physician and activist Rebecca Gomperts, popped up in the US last year in a very particular context.
With the rollback of abortion access across US states well underway, the confirmation of Brett Kavanaugh to the Supreme Court, and the future of Roe v. Wade looking increasingly grim, women who want to safely terminate their pregnancies face an increasing number of roadblocks. So Aid Access offers what Gomperts’s other service, Women on Web, has been doing for years for patients in other countries with restricted health care systems: fast access to medical abortion pills.