Washington, D.C. — On March 26, 2024, the U.S. Supreme Court will hear oral arguments in Alliance for Hippocratic Medicine v. Food and Drug Administration (FDA). This case poses a direct threat to the safety, availability, and use of mifepristone, part of a two-step regimen approved for medication abortion. A new column from the Center for American Progress explores how the FDA’s two most recent decisions on mifepristone reflect the agency’s commitment to medical and scientific expertise, as well as how those decisions contribute to the overall safety of medication abortion and align with standard health care practices. The column also explains how the Alliance case threatens to disrupt both abortion access nationwide and the regulatory process for all drug approvals by the FDA.
Key changes made by the FDA in 2016, 2021, and 2023 to increase the safety of medication abortion include:
- Lowering mifepristone dosage to only what was necessary to be effective: This change lowered the recommended dosage of mifepristone from three 200 milligram tablets (600 mg total) to a single 200 mg tablet taken orally—after a clinical trial suggested a much lower dose was needed to achieve the same results.
- Changing the administration of misoprostol to extend the period of use and reduce unpleasant side effects: The label change modified the administration of misoprostol tablets from taking them orally, making the side effects milder. The label also no longer required people to revisit their provider in-person to use misoprostol because it could now be taken at home.
- Extending gestational limits for two-step abortion care in the first trimester: This change doubled the number of abortion patients who were eligible for a medication abortion from 37 percent to 75 percent—a decision made to account for evidence demonstrating that the medication abortion regimen is safe and effective through 10 weeks of pregnancy.
- Broadening mifepristone prescriber eligibility so that other qualified health providers could prescribe medication abortion: This change reflected the reality that in states where advanced-practice nurses and/or physician assistants are allowed to provide medication abortion, those types of professionals were already the most common provider of care. Research demonstrates that nonphysician professionals can dispense medication abortion just as safely as physicians can.
- Changing follow-up requirements to reduce barriers to care: By changing the timing for patient follow-up from seven to 14 days based on research showing that an in-clinic follow up is not necessary for the safety and efficacy of medication abortion, the FDA allowed for more patient-centered care.
- Removing the in-person dispensing requirement: Requiring a patient to come into the facility simply to pick up the medications does not enhance patient safety. This change helped mitigate the burdens of travel and logistical challenges of getting to a clinic to pick up the prescription.
- Extending dispensing requirements to pharmacists: This change broadened who could be certified from abortion-providing clinicians to pharmacies, allowing people to access medication abortion at their local pharmacy or from a mail-order pharmacy in states that allow it.
“These modifications through the years not only contributed to the overall safety of medication abortion but also aligned with standard medical and health care practices,” said Kierra B. Jones, senior policy analyst for the Women’s Initiative at CAP. “Reinstituting any restrictions would be a detriment to scientific progress and accessibility for countless women and all people who can become pregnant.”
Read the column: “The FDA’s Decisions on Mifepristone Have Advanced the Safety of Medication Abortion” by Kierra B. Jones
For more information or to speak with an expert, please contact Sarah Nadeau [email protected].