The FDA is investigating Aid Access, a European telemedicine abortion provider that began distributing medications in the U.S. earlier this year, CNN reports.
Aid Access uses online consultations to connect healthy women who are less than nine weeks pregnant with a physician. If the woman is deemed eligible for a medication abortion, the organization's founder — Rebecca Gomperts, MD, PhD — will prescribe two pills to terminate the pregnancy, misoprostol and mifepristone. The prescription is sent to a pharmacy in India, which mails the pills to the U.S.
The FDA is questioning whether Aid Access has violated a set of restrictions that the agency placed on Mifeprex, a brand name for mifepristone, when it approved the drug 18 years ago. These restrictions are "necessary to ensure the safe use of Mifeprex," the FDA said in a statement to CNN.
"Mifeprex is only available to be dispensed in certain healthcare settings, specifically, clinics, medical offices and hospitals, by or under the supervision of a certified prescriber," the FDA said. "Mifepristone, including Mifeprex, for termination of pregnancy is not legally available over the internet."
However, recent research has suggested telemedicine is as safe as in-person treatment when dispensing medication abortions, and some clinicians who spoke with CNN argued the FDA's restrictions on the medication may be unnecessary.
Abigail Aiken, MD, PhD, an assistant professor at the LBJ School of Public Affairs at the University of Texas at Austin who researches the topic, told CNN the restrictions don't help to mitigate risk. "In fact, it's actually one of the biggest barriers to the widespread use of a very safe and effective medication," she said.
To read CNN's report, click here.