Washington, D.C.—With controversy over mifepristone continuing to heat up and a recent lawsuit challenging the REMS required for the drug, which is used for medical termination of pregnancy through 10 weeks gestation, the FDA recently clarified its position on Mifeprex and its generic versions.

“Mifeprex and its generic mifepristone tablets, 200 mg, are available under a single, shared system risk evaluation and mitigation strategy (REMS), known as the Mifepristone REMS Program, which sets forth the requirements that must be followed for mifepristone for medical termination of pregnancy through ten weeks gestation,” the FDA advised in an update posted online in mid-March.

Under the program, mifepristone must be dispensed by or under the supervision of a certified prescriber or by certified pharmacies for prescriptions issued by certified prescribers, according to the agency, although it can be in-person or by mail.

While Mifeprex was approved in 2000 with no restrictions, by 2019, when the FDA approved its generic version, the agency approved a single, shared system REMS for mifepristone products when used for medical termination of pregnancy.

The Mifepristone REMS Program was modified on January 3, 2023. Under the Mifepristone REMS Program, the FDA requires that:

• Mifepristone must be prescribed by a healthcare provider that meets certain qualifications and is certified under the Mifepristone REMS Program.
• To become certified to prescribe mifepristone, healthcare providers must complete a Prescriber Agreement Form.
• The Patient Agreement Form must be reviewed with and signed by the patient and the healthcare provider, and the risks of the mifepristone treatment regimen must be fully explained to the patient before mifepristone is prescribed.
• The patient must be provided with a copy of the Patient Agreement Form and mifepristone Medication Guide (FDA-approved information for patients).
• Mifepristone may only be dispensed by or under the supervision of a certified prescriber or by a certified pharmacy on a prescription issued by a certified prescriber.
• To become certified to dispense mifepristone, pharmacies must complete a Pharmacy Agreement Form.
• Certified pharmacies must be able to ship mifepristone using a shipping service that provides tracking information.
• Certified pharmacies must ensure mifepristone is dispensed to the patient promptly.

“Prior to the modifications to the Mifepristone REMS Program in January 2023, there were periods when the in-person dispensing requirement was not being enforced,” the FDA noted. “First, from July 13, 2020, until January 12, 2021, the FDA was enjoined from enforcing the in-person dispensing requirement by an injunction issued in the ACOG v. FDA litigation. On April 12, 2021, the agency stated its intent to exercise enforcement discretion with respect to the in-person dispensing requirement during the COVID-19 public health emergency.”

In 2021, after conducting a comprehensive review of the Mifepristone REMS Program, the FDA decided to modify REMS to reduce the burden on the healthcare delivery system. The FDA announced at the end of 2021 that the modifications to the Mifepristone REMS Program would consist of removing the requirement that mifepristone be dispensed only in certain healthcare settings (i.e., clinics, medical offices, and hospitals)—essentially an in-person dispensing requirement. In addition, the agency added the requirement that pharmacies that dispense the drug be certified.

The guidance pointed out that healthcare providers who want to be certified to prescribe mifepristone must have the ability to date pregnancies accurately and the ability to diagnose ectopic pregnancies. They also must be able to provide any necessary surgical intervention or have made arrangements for others to provide for it, as well as be able to ensure that patients have access to medical facilities for emergency care.

“Some states allow healthcare providers other than physicians to prescribe medications. Healthcare providers should check their individual state laws,” the FDA added.

The FDA also has determined that the REMS does not need to mandate how providers clinically assess patients for the duration of pregnancy and for ectopic pregnancy, explaining, “Aspects of a patient’s medical history that may constitute contraindications to medical abortion may be elicited without direct physical contact with the certified prescriber and can be done in different types of health care settings, thus certified prescribers are not necessarily required to be physically present with the patient when they prescribe mifepristone.”

Meanwhile, the FDA strongly discourages buying mifepristone online or personally transporting it from a foreign country.

The battle over abortion is increasingly focused on medications—not just surgical procedures—often putting pharmacists in a precarious position. In the latest volley, 12 state attorney generals who support the right to abortion have filed a federal lawsuit objecting to the use of REMS with mifepristone.

Bob Ferguson, the state attorney general of Washington, is coleading a multistate federal lawsuit against the FDA, maintaining that the Biden Administration singled out mifepristone, one of the two drugs used for medication abortions for excessively burdensome regulation.

Mr. Ferguson also filed a preliminary injunction asking the court to halt the enforcement of the FDA’s restrictions on mifepristone while the case continues.

The lawsuit pointed out that only 60 drugs fall under REMS restrictions, which are supposed to apply only to inherently dangerous drugs, such as opioids like fentanyl or high-dose sedatives.

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

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