FDA-Required Mifepristone Form Added Little Medication Abortion Knowledge

Reviewing and signing the FDA-required mifepristone patient agreement form (PAF) did not produce a clinically meaningful increase in medication abortion knowledge beyond standard clinic counseling, according to a randomized clinical trial published in JAMA Internal Medicine.

Under the FDA’s Risk Evaluation and Mitigation Strategy (REMS) for mifepristone, patients must sign the PAF before receiving the drug. The trial (NCT07604675) recruited people aged 15 years or older receiving mifepristone and misoprostol for abortion or miscarriage at 5 facilities in California, Colorado, Illinois, Kansas, and Minnesota from January to October 2025. After standard counseling, including the mifepristone medication guide, participants were randomized to complete a knowledge survey before or after receiving and signing the PAF; 593 completed knowledge items (301 before and 292 after). The primary outcome was a 12-item knowledge score.

Knowledge was high in both groups. In analyses adjusted for site, participants answered a mean of 10.26 of 12 items consistently with the PAF before receiving it and 10.44 after, a nonsignificant difference of 0.18 items (95% CI, −0.04 to 0.39). Results were similar with additional adjustment for abortion history and with multiple imputation.

The items least often answered consistently with the PAF concerned how often treatment does not work (54%) and taking misoprostol 24 to 48 hours after mifepristone (77%). The authors reported that only 1 item, contacting a clinician for a fever of 100.4°F or higher lasting longer than 4 hours, differed significantly by group, and only in fully adjusted analyses. The authors noted that the groups were not perfectly balanced in size or abortion history, that only 5 sites took part, and that a ceiling effect, with 22% of participants achieving perfect scores, may have limited the ability to detect an effect. The trial assessed knowledge beyond routine counseling, not whether the PAF ensures a minimum level of knowledge, and did not assess direct clinical harms.

The authors concluded that the PAF provides little additional educational benefit in routine clinical care and that the FDA should consider removing the requirement.

Source: Biggs MA, Ehrenreich K, Kaller S, Ralph L, Grossman D. Mifepristone patient agreement form and medication abortion knowledge: a randomized clinical trial. JAMA Intern Med. Published online October 19, 2026. doi:10.1001/jamainternm