The Food and Drug Administration (the “FDA”) has approved a modification to the Mifepristone Risk Evaluation and Mitigation Strategy (“REMS”) Program, increasing the accessibility of mifepristone for patients with a prescription. [1], [2]
Background
The FDA approved the use of Mifeprex (a brand-name version of mifepristone), in 2000 with certain restrictions to ensure the safe use of the drug. The restrictions included requirements that (i) a patient must obtain Mifeprex (mifepristone) from, or under the supervision of, a physician who can, and has, assessed the patient, and (ii) a patient must obtain Mifeprex (mifepristone) in person at a clinic, medical office, or hospital. [3], [4] In 2011, the FDA approved a REMS Program for Mifeprex (mifepristone), and in 2019, the FDA approved the Mifepristone REMS Program as a single, shared system REMS for mifepristone products (Mifeprex and its generic form, Mifepristone Tablets, 200 mg) for the medical termination of intrauterine pregnancy through 10 weeks gestation. [5]
The FDA’s approval of the modifications to the Mifepristone REMS Program started in 2021, when the FDA conducted a comprehensive review of the Mifepristone REMS Program and determined that the REMS should be modified. Applicants for Mifeprex and its generic version, Mifepristone Tablets, 200mg, prepared the proposed REMS modification which was reviewed and approved by the FDA on January 3, 2023.
Impact of Use of Mifepristone in Certain State
From July 13, 2020 through January 12, 2021, the FDA was enjoined from enforcing the in-person dispensing requirement following an injunction issued in ACOG v. FDA, a lawsuit filed by the American Civil Liberties Union on behalf of the American College of Obstetricians and Gynecologists in May 2020, asking the Maryland U.S. District Court to require the FDA suspend the in-person requirement on dispensing mifepristone in light of the pandemic. [6] Subsequently, in April 2021, the FDA issued guidance suspending in-person dispensing and in-person signature requirements, further increasing accessibility across the United States of mifepristone; however, in June 2022, the U.S. Supreme Court held in Dobbs v. Jackson Women’s Health Organization that the U.S. Constitution does not confer a right to abortion. [7] Following the Dobbs decision, some states invoked existing laws or passed new laws banning abortions and restricting abortion care, which resulted in limitations on access to mifepristone or restriction on the use of mifepristone in certain states.
Requirements Under FDA Approval of Mifepristone REMS Program Modifications
The FDA’s approval of commercial dispensing of mifepristone likely will not change the current practice of prescribing and dispensing mifepristone for abortion care in states where abortion is illegal, but in states where abortion is legal, the FDA’s approval may expand patients’ access to the drug. However, with the approval of commercial dispensing of mifepristone also comes strict requirements for pharmacies and healthcare providers.
First, healthcare providers who prescribe mifepristone must be certified in the Mifepristone REMS Program and must complete the Prescriber Agreement Form, which requires that prescribers agree to meet certain qualifications and follow the guidelines for use of mifepristone.[8]
Second, mifepristone can only dispensed by or under the supervision of certified prescribers, or by certified pharmacies on prescriptions issued by certified prescribers. Medical offices, clinics, and hospitals, where mifepristone will be dispensed by or under the supervision of a certified prescriber will not need to be further certified. However, pharmacies will need to submit a Pharmacy Agreement Form through an authorized representative to the authorized distributor who will be providing the drug in order to dispense to patients in-person or through a shipping service.
Third, patients must be informed about the risk of serious complications associated with mifepristone. A patient must be provided with a mifepristone Medication Guide, an FDA-approved information packet for patients. A patient’s healthcare provider and/or the certified prescriber will also need to review a Patient Agreement Form with the patient, explain the risks of using mifepristone, and both the patient and provider will need to sign the Patient Agreement Form, before mifepristone is prescribed.
Model Forms noted above are included in the FDA’s Summary Review of Mifepristone REMS.
What Does this Mean for Businesses?
In states where abortion care is legal some pharmacy retailers have already responded to the FDA’s approval, noting plans to certify pharmacies to dispense mifepristone. In states where abortion and abortion care are illegal or restricted, it remains to be seen how and whether pharmacies will certify to dispense mifepristone for patients with prescriptions who would use the drug for medical conditions that are not related to abortion care such as Cushing’s syndrome.
FOOTNOTES
[1] Mifepristone is the generic form of Mifeprex, and is a drug used in conjunction with misoprostol in a regimen approved by the FDA to end an early pregnancy, through 70 days gestation. Information about Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation, U.S. Food and Drug Administration (2023), https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation (last visited Jan 10, 2023). (“FDA Information about Mifepristone.”)
[2] A Risk Evaluation and Mitigation Strategy Program (or “REMS Program”) is a drug safety program that may be required by the FDA for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. Risk Evaluation and Mitigation Strategies (REMS), U.S. Food and Drug Administration (2021), https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems.
[3] NDA 20-687, U.S. Food and Drug Administration (2000), https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20687appltr.pdf. (“FDA Letter Approving Mifepristone (2000).”)
[4] Also known as the “in-person dispensing requirement”. FDA Letter Approving Mifepristone (2000).
[5] Approval letter: NDA 020687/S-022, U.S. Food and Drug Administration (2019), https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020687Orig1s022ltr.pdf (last visited Jan 10, 2023). (“FDA Letter re Mifepristone SSS REMS Program (2019).”)
[6] ACOG v. FDA, In the Courts (2020), https://www.acog.org/-/media/project/acog/acogorg/files/advocacy/acog-v-fda-complaint-mifepristone-covid19.pdf?la=en&hash=2C5C6C65F3E6C8A693ACD649C7C12129 (last visited Jan 10, 2023).
[7] Dobbs v. Jackson Women's Health Organization, 597 U.S. ___ (2022).
[8] Summary Review of Mifepristone REMS, NDA 02-687 (2023), https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2023/020687Orig1s025SumR.pdf (last visited Jan 10, 2023). (“Summary Review of Mifepristone REMS”)