FDA Releases Updated REMS Requirements for Mifepristone
On January 3rd, 2023, the FDA released updated Risk Evaluation and Mitigation Strategies (REMS) for Mifepristone, opening a pathway for pharmacies in all settings, including brick-and-mortar retail pharmacies, to become certified to dispense Mifepristone.
What is Medication Abortion Care?
Medication abortion care is a safe, effective non-invasive abortion option that is approved for use up to 10 weeks in pregnancy. It involves the use of two FDA-approved drugs:
A pill that inhibits the physiological action of progesterone, a hormone needed to sustain pregnancy.
Pills taken within 24-48 hours of mifepristone to complete the abortion process.
The Pharmacy Community Should Know That...
Medication abortion care is FDA-approved, safe, and effective.
It has been in use for 20+ years
More than 4.9 million people have safely used medication abortion since FDA approved it in 2000
It is 99.6% effective within first 10 weeks gestation
Serious adverse events occur in fewer than 0.5% of medication abortions
Mifepristone and misoprostol can also be prescribed to manage early miscarriage.
Increase in Medication Abortion Care
Factors contributing to increase:
As of 2020, medication abortions account for the majority of all US abortions
Source: Guttmacher Institute
Telehealth has shortened wait times and increased access for underserved, minority, and rural communities.
patient satisfaction with medication abortion care
Federal Regulation of Medication Abortion
What is a Certified Prescriber?
Healthcare providers who meet certain qualifications to prescribe medication abortion may become certified. Prescribers must be able to:
Changes to REMS for Medication Abortion Care
New FDA Certification Requirements for Pharmacies
In December 2021, FDA announced that the mifepristone REMS would be updated to maintain mail-order and online practice, and expand into brick-and-mortar pharmacy practice. On January 3, 2023, the FDA released a REMS update and certification requirement for prescribers and pharmacies. As of January 3, 2023, certified prescribers can send prescriptions to certified pharmacies (brick-and-mortar, online, and mail-order) to dispense.
Some States are Attempting to Override FDA Through Legislation
State are passing laws to override FDA’s scientific authority and add new restrictions on medication abortion, including:
Other state restrictions impose additional burdens, such as: