The Food and Drug Administration has sent warning letters to two online abortion-pill providers for selling unapproved versions of drugs, Vox reports.
One of those providers is Aid Access, an abortion-by-mail provider that began providing mifepristone and misoprostol—a drug combination commonly used for early term abortions—to women in the United States in October of last year. (Dutch doctor Rebecca Gomperts, who runs Aid Access, has offered abortion pills online in other countries since 2006 via the service Women on Web.)
As Emma Sarappo wrote in Pacific Standard in October, both the FDA and the World Health Organization recommend the two drugs used together as a safe abortion protocol, but the FDA advises against ordering them online. Is doing so legal? That’s hard to say, as Sarappo explained:
Aid Access has a doctor prescribe you medication, which is filled at a pharmacy in India and shipped to your house. The FDA’s personal import rules are a bit uneven, but, generally, it “does not object” to importation of drugs for personal use. And because abortion is such a politically volatile issue, prosecutors have charged women in different states for acquiring and taking abortifacients.
Now, according to the warning letter sent to Aid Access, the company’s failure to immediately cease sales of unapproved versions of mifepristone and misoprostol “may result in FDA regulatory action, including seizure or injunction.”
The letter explains that selling such drugs violates the FD&C Act (the Federal Food, Drug, and Cosmetic Act, a set of 1938 laws establishing the FDA’s authority), in part because “they are not generally recognized as safe and effective for their labeled use.” Because non-FDA-approved products are not subject to the agency’s oversight and safeguards, “The substitution of unapproved drugs for FDA-approved prescription drugs poses significant health risks to U.S. consumers,” the letter states.
FDA-approved versions of these drugs are available in the U.S., but they’re not very accessible. As Sarappo reported, mifepristone is not available at regular pharmacies, and it can cost up to $1,000.
