The U.S. Food and Drug Administration (FDA) has called out providers who are giving out abortion pills to patients who are not pregnant.
“The FDA is concerned about the advance prescribing of mifepristone for this use,” an anonymous FDA spokesperson told POLITICO on Friday. “Mifepristone is not approved for advance provision of a medical abortion.”
The agency said that providers who are prescribing the abortion drugs in this way are not doing so under the authority of the FDA and are possibly endangering the women who are getting the pills.
Mifepristone, which is the first pill taken in the abortion pill regimen, essentially starves the baby from progesterone, which the unborn baby needs in order to develop. Progesterone assists the uterus in growing during pregnancy. The second pill, misoprostol, causes the woman to go into labor.
The spokesperson told the outlet that such acts are possibly dangerous for patients and if mifepristone is given to a woman before she is pregnant, this would inhibit the ability of providers to make sure she is safe.
One of the providers taking such dangerous steps is Choix, a telemedicine company, whose CEO Cindy Adam told Politico that limitations on abortions pills are not needed and claimed the drugs are safe. She said the company provides “ongoing, supportive” care for the entirety of the process. She added that the company looks for concerning issues, and also simply tells the women to get additional care if they do get pregnant.
“Science has consistently shown that when people have accurate information and access to abortion pills they can safely end a pregnancy in their own homes,” Adam said. “Providing abortion care through advance provision should be no different.”
Abortion pills used to have a Risk Evaluation and Mitigation Strategy (REMS) which did not permit providers to give out the pills without first seeing a woman. During the COVID-19 pandemic, the FDA allowed the first set of pills to be given out without requiring providers to see patients in person. In December of 2021, the agency decided to allow the pills to be sent through the mail indefinitely.
The action raised concerns that women would be given the pills without first being examined, which could increase the use of the drugs by abusers and human traffickers. It could also put women at risk for other reasons. Abortion pills should not be used on a woman who is in the later stages of pregnancy or who has an ectopic pregnancy, when the fertilized egg is implanted outside of the uterus. Taking abortion pills in either of these situations is potentially life-threatening for the woman.