In the United States, recent laws restricting access to abortion have given rise to a large number of websites selling abortion pills of questionable origin online. On Tuesday, the FDA sent warning letters to the two main players: the website AidAccess.org and the company Rablon, which includes at least 87 websites such as AbortionPillRx.com or AbortPregnancy.com. The FDA has requested for them to “immediately stop selling” their pills and to respond to the FDA “within 15 working days, specifying the measures taken to address these regulatory violations”. A spokesperson added that “failure to comply with this obligation may result in FDA regulatory action, including seizure or injunction, without further notice”.
As part of a risk mitigation program called REMS, which applies to all drugs proven to be dangerous, the approved legal versions of mifepristone and misoprostol – the two molecules necessary for medical abortion – are only issued by approved health centres and are not available in any pharmacy. “Providers must sign a document indicating that they will ensure that patients have access to surgical abortion or emergency care in the event of a problem”. This is impossible to do online.
To circumvent this legal obligation, AidAccess sources the pills in India, with versions of mifepristone and misoprostol that are not recognized by the FDA and are banned in the US. “Patients are examined during an online consultation about their pregnancy and medical history. If they meet specific criteria – good health, less than 10 weeks’ pregnant, living less than an hour from a hospital – Gomperts fills a prescription and sends it to a pharmacy in India that she knows and trusts. The pills are then mailed from India to the woman’s home for a fee of $95 (…). And patients can access real-time instructions and support if necessary
This procedure involves several risks:
- The “risk of adulteration or improper dosing” of the pills,
- The risk of degradation of some of the tablets,
- The risk of inappropriately issuing the tablets to a patient due to lack of proper consultation. “A number of groups should avoid mifepristone and misoprostol, including women with ectopic pregnancies (or pregnancy that grows outside the womb, which can only be confirmed by getting medical imaging), women with an intrauterine device in place, and women who have chronic adrenal failure or who are on long-term corticosteroid therapy.
“Anyone who buys pills from a foreign pharmacy could risk arrest, as US law does not permit the importation of prescription drugs except in very limited circumstances”. As for those who buy their abortion pills through Rablon, the “Abortion pill pack” they receive does not even contain instructions, with serious complications occurring in less than 0.5% of patients.
Pro-choice groups see REMS as just a “medically unnecessary obstacle” to prevent women from having an abortion. “We’ve been very active in combating illegal online sales of unapproved medicine, this is not about the particular product. This is business as usual for the FDA,” the Agency argued.
1] REMS for Risk Evaluation and Mitigation Strategies: Approved Risk Evaluation and Mitigation Strategies (REMS).
2] Rebecca Gomperts, a Dutch doctor and activist who created the AidAccess website.