FDA clamps down on sale of unapproved mail-order abortion pills

Washington D.C., Mar 14, 2019 / 04:01 pm (CNA).- As part of a wide-reaching crackdown on the online sale of illegal drugs, the US Food and Drug Administration has warned several online providers of abortion-inducing medications to stop the sale of unapproved abortion pills.

The FDA sent last week a letter to Rablon, an online pharmacy network, and Aid Access, requesting they immediately desist selling unapproved versions of the abortion drugs mifepristone and misoprostol online.

According to the FDA warning letter, the “sale of misbranded and unapproved new drugs poses an inherent risk to consumers who purchase those products.”

“Drugs that have circumvented regulatory safeguards may be contaminated; counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether,” the letter states.

Mifepristone and misoprostol are two drugs taken together to carry out a medical abortion. They work by inducing miscarriage in pregnancies before 10 weeks.

FDA-approved versions of the drugs have been available to US consumers since 2000, but may only be prescribed by a certified health care provider in a hospital, clinic, or medical office setting. They may not be sold online or in a retail pharmacy.

The health care provider must inform patients about the serious risks associated with use of the medications, and sign a waiver certifying the patient has access to emergency care or a surgical abortion in the case of complication.

These requirements are part of an FDA risk mitigation program called REMS, which is used for all higher-risk medications.

The letter to Aid Access stated that the FDA-approved version of mifepristone, called “Mifeprex,” is under the REMS program because “the drug carries a risk of serious or even life-threatening adverse effects, including serious and sometimes fatal infections and prolonged heavy bleeding, which may be a sign of incomplete abortion or other complications.”

Failure by the websites to correct the violations outlined, the FDA stated, could result in “regulatory action, including seizure or injunction, without further notice.”

Aid Access is a website that says it offers abortion-inducing drugs to healthy women who are nine weeks pregnant or less.

If women qualify for the pills through online consultations, Aid Access writes them prescriptions for the two drugs. These prescriptions are filled at a pharmacy in India, which mails the drugs to women in the U.S. The service costs $95, and the website notes that financial aid is available.

Rablon is an online pharmacy network owning at least 87 websites, with sites such as AbortionPillRx.com and AbortPregnancy.com offering mail-order access to mifepristone and misoprostol.