What changes to the Mifeprex application did the FDA approve on March 29, 2016?
The FDA first approved Mifeprex in 2000. In 2016, the agency approved a supplemental application submitted by the drug company that markets Mifeprex. This approval included changes in the dose of Mifeprex and the dosing regimen for taking Mifeprex and misoprostol (including the dose of misoprostol and a change in the route of misoprostol administration from oral to buccal (in the cheek pouch), the interval between taking Mifeprex and misoprostol, and the location at which the woman may take misoprostol). The approval also modified the gestational age up to which Mifeprex has been shown to be safe and effective, as well as the process for follow-up after administration of the drug. In addition, the labeling was revised to meet the current labeling requirements in the FDA’s regulations. The FDA also approved changes to the existing Risk Evaluation and Mitigation Strategy (REMS) to reflect the changes approved in the supplemental application, and to make the Mifeprex REMS consistent with more recently approved REMS.Find approval information for this supplement here.
Find more information here: Mifeprex (mifepristone) InformationOf note, on April 11, 2019, FDA approved a supplemental application for Mifeprex, approving modifications to the existing approved REMS for Mifeprex to establish a single, shared system REMS for mifepristone products (including Mifeprex as well as the approved generic version of Mifeprex) for the medical termination of intrauterine pregnancy through 70 days gestation. In establishing the single, shared system REMS, no changes were made to the substantive elements of the REMS. This single, shared system REMS is known as the Mifepristone REMS Program.Find approval information for this 2019 supplement here.
The approved generic version of Mifeprex generally has the same labeling as Mifeprex. As discussed below (see question 7), the approved generic version of Mifeprex is required to use the single, shared system REMS with the brand product, Mifeprex.
Where can women get Mifeprex?
Mifeprex is supplied directly to healthcare providers who meet certain qualifications. It is only available to be dispensed in certain healthcare settings, specifically, clinics, medical offices, and hospitals, by or under the supervision of a certified prescriber. It is not available in retail pharmacies, and it is not legally available over the Internet. These requirements also apply to the approved generic version of Mifeprex.See Question 14 below for new information, added on April 13, 2021.
What qualifications must healthcare providers have to obtain and dispense Mifeprex?
Healthcare providers who would like to become certified to prescribe Mifeprex must have the ability to date pregnancies accurately and to diagnose ectopic pregnancies. Healthcare providers must also be able to provide any necessary surgical intervention, or have made arrangements for others to provide for such care. Healthcare providers must be able to ensure that women have access to medical facilities for emergency care, and must agree to other responsibilities, including reviewing and signing the Patient Agreement Form with the patient and providing each patient with a copy of the signed Patient Agreement Form and the Medication Guide.Healthcare providers who prescribe and who meet certain qualifications are authorized to order and dispense Mifeprex. Some states allow healthcare providers other than physicians to prescribe medications. Healthcare providers should check their individual state laws.These requirements also apply to the approved generic version of Mifeprex.See Question 14 below for new information, added on April 13, 2021.
Are there restrictions on the distribution of Mifeprex?
When the agency reviewed and approved the original new drug application for Mifeprex in 2000, it concluded that certain distribution restrictions were necessary to ensure the safe use of that drug. These restrictions were converted to a risk evaluation and mitigation strategy (REMS) in 2011. In 2016, after reviewing the additional data and information submitted by the sponsor of Mifeprex, and after taking into consideration the safety data that had become available since the initial approval of Mifeprex, the FDA concluded that certain restrictions continue to be necessary to ensure the safe use of Mifeprex.These restrictions also apply to the approved generic version of Mifeprex. Under the law, the approved generic version of Mifeprex is required to use a single, shared system REMS with the brand product, Mifeprex. This single, shared system REMS, known as the Mifepristone REMS Program, sets forth the distribution requirements that must be followed for both Mifeprex and the approved generic version of Mifeprex.Under the Mifepristone REMS Program, Mifeprex and the approved generic version of Mifeprex may only be supplied directly to healthcare providers who are certified to prescribe the drug product and who meet certain qualifications. Under this REMS, the products are only available to be dispensed in certain healthcare settings, specifically, clinics, medical offices and hospitals, by or under the supervision of a certified prescriber. They are not available in retail pharmacies and are not legally available over the Internet. The FDA warns consumers they should not buy Mifeprex or GenBioPro, Inc.’s approved generic version of Mifeprex, Mifepristone Tablets, 200 mg., over the Internet because they will bypass important safeguards designed to protect their health.
12.7.21 from: https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifeprex