Removing unnecessary barriers to medication abortion
Ibis President Kelly Blanchard joined a group of experts from several disciplines to release a commentary published last week in the New England Journal of Medicine highlighting the harms caused by overregulation of mifepristone in the United States. The FDA regulation mechanism known as REMS (Risk Evaluation and Mitigation Strategy) places unnecessary burdens on people accessing medication abortion. Though mifepristone is safe and effective, the REMS require that it can only be dispensed to patients in clinics, medical offices, and hospitals by or under the supervision of a certified provider, and that each person taking mifepristone must be given a Medication Guide and sign an FDA-approved Patient Agreement. The REMS restrictions place medically unnecessary burdens on providers and patients, which has a particular impact on rural women or those with limited resources.
Evidence has clearly demonstrated that medication abortion is a safe, effective option for ending a pregnancy. Removal of the REMS would help to increase access to safe abortion and expand the potential impact of innovative service models like the telemedicine provision of abortion care, which our work has shown to be safe, effective, and acceptable to patients. Eliminating the REMS to reflect the safety and efficacy of mifepristone would remove unnecessary barriers and help to improve access for all people, regardless of income or zip code.