FDA restrictions on mifepristone—used for miscarriage and abortion care—are based on politics, not medical science.
Last month, the Biden administration announced that the U.S. Food and Drug Administration (FDA) would undertake a review of longstanding restrictions on the medication mifepristone used for miscarriage and abortion care. The announcement followed an FDA decision in April to lift in-person dispensing requirements on mifepristone for the duration of the pandemic.
While many advocates celebrated these long-awaited and hard-fought-for achievements, others cautioned that lifting the FDA restrictions would not guarantee telemedicine abortion access for people in many states.
The reason is that 19 states require the clinician providing a medication abortion to be physically present when the medication is administered, thereby prohibiting the use of telemedicine to prescribe medication for abortion remotely. Even if the FDA restrictions were to be lifted, these state-level bans would still block telemedicine access to medication abortion in these states.
However, lifting federal restrictions on mifepristone is a key step toward challenging state telemedicine abortion bans. The FDA approved mifepristone for use in the U.S. in 2000, but due to intense anti-abortion pressure, the agency tightly restricted the medication under a drug safety program now called the Risk Evaluation and Mitigation Strategy or REMS.
Under this program, pharmacies can’t distribute the drug; only certified physicians can dispense mifepristone, which they must give directly to the patient.
Anti-abortion advocates and lawmakers point to the FDA REMS restriction as justification for their argument that telemedicine abortion is not safe and should be banned. For example, Republican lawmakers in Pennsylvania last year passed a telehealth bill exempting drugs listed on the FDA’s REMS list, leading the Democratic governor to veto the bill.
However, the FDA REMS restriction is based on politics, not medical science. In fact, mifepristone is an extremely safe medication. Leading medical authorities, including the American Medical Association and the American College of Obstetricians and Gynecologists, have stated that medication abortion is very safe and call for the elimination of the REMS restriction.
Removing the REMS will not create full access to telemedicine abortion for all people, but it is a critical first step that will allow telemedicine abortion in the majority of states without bans and create the necessary foundation for challenging state-level bans where they exist.
Similar to how ending criminal sodomy laws paved the way to legalizing same-sex marriage, removal of the REMS restriction on mifepristone is essential to normalizing telemedicine abortion and will be an important tool for advocates as they lobby states to eliminate telemedicine abortion bans.