On January 3, 2023, the U.S. Food and Drug Administration (“FDA”) released an updated Mifepristone Risk Evaluation and Mitigation Strategy (the “Mifepristone REMS Program”), which reverses the requirement that the drug be dispensed directly to a patient by certified prescriber in a clinic or a medical office (the “in-person dispensing requirement”). The updated Mifepristone REMS Program allows pharmacies, including large chain and mail-order companies, to dispense mifepristone directly to patients with a prescription from a certified provider. Interested stakeholders will need to carefully consider the impact of state law requirements on the ability to dispense the drug.
February 9, 2023 UPDATE: A number of lawsuits have been filed challenging FDA’s approval of mifepristone and the REMS. Hall Render is actively monitoring these updates.
Overview
Since 2000, mifepristone (brand name Mifeprix) has been FDA approved for the medical termination of pregnancy through ten weeks’ gestation. Mifepristone is also often utilized for the off-label purpose of miscarriage management. Until this update, the in-person-dispensing requirement was in place, although enforcement of the requirement has been suspended during the COVID-19 public health emergency. The updated Mifepristone REMS Program expands access to mifepristone by allowing pharmacies, including large chain and mail-order companies, to dispense mifepristone directly to patients with a prescription from a certified provider.
The FDA continues to require prescribers and pharmacies to be certified using the mifepristone distributor form. The prescriber form directs prescribers to submit the completed form to the distributor and each certified pharmacy to which the prescriber wishes to submit mifepristone prescriptions. Prescribers who will be dispensing the medication themselves, through other health care providers under their supervision, or in a clinical setting, are only required to submit the form to the distributor.
Pharmacies dispensing mifepristone are likewise required to complete a brief certification form. Pharmacies must designate an authorized representative to carry out the certification process and oversee implementation and compliance with the Mifepristone REMS Program on behalf of the pharmacy.
Conflict with State Laws Regulating Abortion and Telehealth
The FDA is authorized to regulate and establish methods for medication prescription and dispensing, while states have the authority to set standards for medical and pharmaceutical practice. Providers prescribing and dispensing mifepristone should be aware of potential conflicts between the updated Mifepristone REMS Program and state authority governing access to abortion and telehealth.
Following the United States Supreme Court’s ruling in Dobbs v. Jackson Women’s Health (the “Dobbs decision”), which held that there is no federal constitutional right to abortion, a number of states have restricted or banned abortion care by passing new laws and/or by actively enforcing abortion bans that existed prior to the decision in Roe v. Wade. Such laws may apply to both surgical abortions and to termination of pregnancy using medication, including mifepristone.
A number of states have also instituted laws that specifically restrict medical abortion by, for example, prohibiting advanced practice providers from administering medical abortion; prohibiting the use of medical abortion starting at a gestational age earlier than ten weeks; and/or requiring that the prescribing clinician must be in the physical presence of the patient when the medication is administered (thus prohibiting the use of telehealth for prescription of medical abortion).
Accordingly, the updated Mifepristone REMS Program could have the greatest impact in states that have liberalized abortion laws in the wake of the Dobbs decision and in those states that permit abortion care via telehealth. In contrast, the updated Mifepristone REMS Program may not have a substantial impact in states that prohibit abortion and/or in states with laws mandating in-person abortion care. However, even in states that restrict abortion, mifepristone, when used for the off-label purpose of miscarriage management, may now be made available through retail pharmacies with a prescription if not specifically prohibited by state law.
Looking Ahead and Practical Takeaways
While the FDA revised the Mifepristone REMS Program to allow greater flexibility in dispensing mifepristone, both prescribers and pharmacists should be aware of applicable state laws affecting the permissibility of prescribing and dispensing the drug for both abortion care and for miscarriage management.
Additionally, both the Mifepristone REMS Program and state laws restricting the use of medical abortion have been frequent subjects of litigation. Consequently, it is likely that ongoing litigation and state legislative changes will continue to evolve as the ripple effects of the Dobbs decision continue.
Health care providers and pharmacies should consider taking the following actions in response to the updated Mifepristone REMS Program:
- Closely monitor ongoing developments, including litigation and state law actions related to prescribing of mifepristone;
- Complete the relevant FDA form in order to become certified as a prescriber and/or dispensing pharmacy; and
- Review current policies and procedures related to the prescribing and dispensing of mifepristone to ensure consistency with the updated Mifepristone REMS Program and relevant state law.
Hall Render is actively tracking the updated Mifepristone REMS Program as well as the related state law issues. If you have questions regarding mifepristone or need assistance in reviewing and updating your mifepristone distribution procedures, please contact:
- Jennifer Skeels at (317) 977-1497 or jskeels@hallrender.com;
- Todd Nova at (414) 721-0464 or tnova@hallrender.com;
- Raminta Kizyte at (303) 557-2112 or rkizyte@hallrender.com;
- Caitlin Bell-Butterfield at (919) 228-2408 or cbell-butterfield@hallrender.com; or
- Your primary Hall Render contact.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot give legal advice outside of an attorney-client relationship.
