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  5. Questions and Answers on Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation
  1. Postmarket Drug Safety Information for Patients and Providers

Questions and Answers on Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation

General Information

  1. What is mifepristone and how does it work?

    Mifepristone is a drug that blocks a hormone called progesterone that is needed for a pregnancy to continue. Mifepristone, when used together with another medicine called misoprostol, is used to end a pregnancy through ten weeks gestation (70 days or less since the first day of the last menstrual period). The approved mifepristone dosing regimen is:

    • On day one: 200 mg of mifepristone taken by mouth

    • 24 to 48 hours after taking mifepristone: 800 mcg of misoprostol taken buccally (in the cheek pouch), at a location appropriate for the patient

    • About seven to fourteen days after taking mifepristone: follow-up with the health care provider

  1. When did the FDA approve mifepristone for medical termination of pregnancy?

    The FDA first approved Mifeprex (mifepristone) in September 2000 for medical termination of pregnancy through seven weeks gestation and this was extended to ten weeks gestation in 2016. FDA approved a generic version of Mifeprex, Mifepristone Tablets, 200 mg, in April 2019. The agency’s approval of this generic reflects the FDA’s determination that Mifepristone Tablets, 200 mg, is therapeutically equivalent to Mifeprex and can be safely substituted for Mifeprex. Like Mifeprex, the approved generic product is indicated for the medical termination of intrauterine pregnancy through 70 days gestation. The labeling for the approved generic version of Mifeprex is consistent with the labeling for Mifeprex.

  1. Who should not take mifepristone, in a regimen with misoprostol, for medical termination of pregnancy?

    An individual should not take mifepristone, in a regimen with misoprostol, for medical termination of pregnancy if it has been more than 70 days since the first day of their last menstrual period, or if they:

    • have an ectopic pregnancy (a pregnancy outside of the uterus)

    • have problems with the adrenal glands (the glands near the kidneys)

    • are currently being treated with long-term corticosteroid therapy (medications)

    • have had an allergic reaction to mifepristone, misoprostol or similar drugs

    • have bleeding problems or are taking anticoagulant (blood thinning) drug products

    • have inherited porphyria (a rare disorder that can affect the liver and other organs)

    • have an intrauterine device (IUD) in place (it must be removed before taking mifepristone)

  1. Is it safe to use mifepristone?

    Yes. Mifepristone is safe when used as indicated and directed and consistent with the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program. The FDA approved Mifeprex more than 20 years ago based on a thorough and comprehensive review of the scientific evidence presented and determined that it was safe and effective for its indicated use. As of 2016, it can be used for medical termination of pregnancy up to 70 days of gestation. The FDA’s periodic reviews of the postmarketing data for Mifeprex and its approved generic have not identified any new safety concerns with the use of mifepristone for medical termination of pregnancy through 70 days gestation. As with all drugs, the FDA continues to closely monitor the postmarketing safety data on mifepristone for the medical termination of pregnancy.

  1. What are the possible side effects of using mifepristone for medical termination of pregnancy through ten weeks gestation?

    The possible side effects are described in the Adverse Reactions section of the labeling and in the Medication Guide for mifepristone.

  1. What serious adverse events have been reported after the use of mifepristone for medical termination of pregnancy through ten weeks gestation?

    As with all approved drugs, when the FDA receives new information regarding adverse events, the agency reviews the new information and, as appropriate, takes necessary action. This could include, for example, providing updates to health care providers and their patients so that they have information on how to use a drug safely.

    It is common for the FDA to receive reports of serious adverse events for prescription drugs after they are approved. Many drugs are associated with serious adverse events that are known at the time of approval and considered when the FDA makes its approval decision. The FDA continuously reviews reports of adverse events to, among other things, determine whether they are known risks or whether they are signals of emerging safety concerns.

    The FDA has received reports of serious adverse events in patients who took mifepristone. As of December 31, 2022, there were 32 reports of deaths in patients associated with mifepristone since the product was approved in September 2000, including two cases of ectopic pregnancy (a pregnancy located outside the womb, such as in the fallopian tubes) resulting in death; and several fatal cases of severe systemic infection (also called sepsis). The adverse events cannot with certainty be causally attributed to mifepristone because of concurrent use of other drugs, other medical or surgical treatments, co-existing medical conditions, and information gaps about patient health status and clinical management of the patient. A summary report of adverse events that reflects data through December 31, 2022, is here. The FDA has reviewed this information and did not identify any new safety signals. The FDA intends to update this summary report as appropriate.

  1. What should health care providers watch for in patients who have taken mifepristone for medical termination of pregnancy through ten weeks gestation?

    Health care providers should review the approved labeling for Mifeprex and the approved generic, Mifepristone Tablets, 200 mg. The signs and symptoms they should watch for are included in the labeling, available here.

  1. What is an ectopic pregnancy?

    An ectopic pregnancy is a non-viable pregnancy that develops outside of the womb. It occurs in two percent of all pregnancies. An ectopic pregnancy is usually located in one of the fallopian tubes. As the fetus grows, the tube cannot hold it, causing the tube to rupture (burst) and bleed. Unless they are discovered and treated early, almost 40 percent of ectopic pregnancies rupture suddenly, causing pain and bleeding in the abdominal cavity. The other 60 percent usually cause slow bleeding in the abdomen. Ruptured ectopic pregnancies can be fatal. The approved labeling for Mifeprex and the approved generic, Mifepristone Tablets, 200 mg, states that the use of mifepristone, in a regimen with misoprostol, for the medical termination of pregnancy through ten weeks gestation is contraindicated in patients with confirmed or suspected ectopic pregnancy.

  1. Does the FDA endorse this drug product

    The FDA does not endorse any drug product. The agency evaluates all drug applications submitted by applicants to determine whether the data and information in an application support the approval of the application. The same standards are applied to the drug applications for Mifeprex and the approved generic Mifepristone Tablets, 200 mg, as are applied to all drug applications.

The Mifepristone REMS Program

  1. Why is there a REMS for this product?

    The FDA’s determination as to whether a REMS is necessary for a particular drug is a drug-specific evaluation. The agency considers whether (based on premarketing or postmarketing risk assessments) there is a particular risk or risks associated with the use of the drug that, on balance, outweigh its benefits and whether additional risk mitigation measures beyond the FDA-approved labeling are necessary to ensure that the drug’s benefits outweigh its risks.

    The goal of the Mifepristone REMS Program is to mitigate the risk of serious complications associated with mifepristone when used for medical termination of pregnancy through ten weeks gestation by, among other things, requiring that prescribers have the necessary qualifications to assess whether patients are appropriate candidates for the drug and to provide necessary intervention in case of complications (or have made plans to provide such care through others), ensuring that mifepristone is only dispensed by certified pharmacies or by or under the supervision of certified prescribers, and requiring that patients be informed of the risks of the treatment regimen.

  1. What are the restrictions on prescribing and dispensing mifepristone for medical termination of pregnancy through ten weeks gestation?

    When the agency reviewed and approved the original new drug application for Mifeprex (mifepristone) in 2000, it concluded that certain restrictions were necessary to ensure the safe use of the drug. These restrictions were approved as a risk evaluation and mitigation strategy (REMS) in 2011 and have been modified since then.

    These REMS requirements also apply to the approved generic version of Mifeprex. Mifeprex and the approved generic version of Mifeprex are subject to a single, shared system REMS, known as the Mifepristone REMS Program. This program sets the requirements that must be followed to ensure safe use of both Mifeprex and the approved generic version of Mifeprex.

    Under the Mifepristone REMS Program:

    • Mifepristone must be prescribed by a health care provider that meets certain qualifications and is certified under the Mifepristone REMS Program.

    • In order to become certified to prescribe mifepristone, health care providers must complete a Prescriber Agreement Form.

    • The Patient Agreement Form must be reviewed with and signed by the patient and the health care provider, and the risks of the mifepristone treatment regimen must be fully explained to the patient before prescribing mifepristone.

    • 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 in a timely manner.

    Each REMS is required to have a plan for periodic assessments by the applicant, which are reviewed by the agency to determine whether the REMS is meeting its goals or whether certain goals or elements of the REMS must be modified. FDA may require applicants to modify a REMS if the agency determines that an element is no longer necessary to ensure that the benefits of the drug outweigh the risks or to minimize the burden on the health care delivery system.

  1. How does the Mifepristone REMS Program ensure safe use of the drug?

    The Mifepristone REMS Program requires that in order for patients to receive mifepristone, it must be prescribed by a certified prescriber who meets certain qualifications. Under the Mifepristone REMS Program, mifepristone must be dispensed by or under the supervision of a certified prescriber or by certified pharmacies on prescriptions issued by certified prescribers. The Mifepristone REMS Program is a closed system, meaning prescribers, pharmacies, and distributors are certified or authorized and verified under the REMS prior to distribution or dispensing of the drug. The Mifepristone REMS Program ensures that mifepristone is only distributed to health care providers and pharmacies that have agreed to the REMS requirements.

  1. How does the Mifepristone REMS Program approved in January 2023 differ from the previous REMS requirements?

    Prior to the modifications to the Mifepristone REMS Program in January 2023, the Mifepristone REMS Program required certified prescribers to dispense mifepristone directly to the patient in a clinic, medical office, or hospital. The requirement to dispense directly to the patient in one of these settings was referred to as the “in-person dispensing requirement.” There were periods when the in-person dispensing requirement was not being enforced. 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 determined, based on the available data and information, that the REMS must be modified to reduce burden on the health care delivery system and to ensure the benefits of the product outweigh the risks. On December 16, 2021, the FDA announced that the modifications to the Mifepristone REMS Program would consist of:

    • Removing the “in-person dispensing requirement”

    • Adding a requirement that pharmacies that dispense the drug be certified

    Consistent with the typical process for REMS modifications, the FDA sent REMS Modification Notification letters to the applicants for Mifeprex and the approved generic version of Mifeprex, Mifepristone Tablets, 200 mg. Following receipt of these letters, the applicants prepared a proposed REMS modification and submitted it to their respective applications. Those submissions were reviewed and approved on January 3, 2023. The REMS document and materials are available on the FDA website at: http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm.

  1. Where can patients get mifepristone for medical termination of pregnancy through ten weeks gestation?

    Mifepristone must be prescribed by a certified prescriber who meets certain qualifications and agrees to follow certain guidelines for use. Under the Mifepristone REMS Program, mifepristone can be dispensed by or under the supervision of a certified prescriber or by a certified pharmacy on a prescription issued by a certified prescriber.

  1. What qualifications must health care providers have to become certified to prescribe mifepristone for medical termination of pregnancy through ten weeks gestation?

    Health care providers who would like to become certified to prescribe mifepristone must review the Prescribing Information for mifepristone and must have the ability to date pregnancies accurately and the ability to diagnose ectopic pregnancies. Health care providers must also be able to provide any necessary surgical intervention or have made arrangements for others to provide for such care. Health care providers must be able to ensure that patients 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.

    Some states allow health care providers other than physicians to prescribe medications. Health care providers should check their individual state laws.

  1. Are patients required to see a health care provider in person before obtaining mifepristone for medical termination of pregnancy through ten weeks gestation?

    No. The Mifepristone REMS Program does not require patients to see a health care provider in person before obtaining mifepristone for medical termination of pregnancy through ten weeks gestation. Mifeprex and the approved generic Mifepristone Tablets, 200 mg, are indicated, in a regimen with misoprostol, to terminate a pregnancy up to 70 days gestation and contraindicated for certain patients, including those with an ectopic pregnancy. The FDA has determined that it is not necessary for the REMS to mandate how providers clinically assess patients for duration of pregnancy and for ectopic pregnancy. The prescription labeling for Mifeprex and the approved generic provide guidance to prescribers regarding how they can confirm the gestational age of the pregnancy and confirm that the pregnancy is located in the uterus. Aspects of a patient’s medical history that may constitute contraindications to medical termination of pregnancy 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. As explained above (Question 15), health care providers certified under the Mifepristone REMS Program must also be able to provide any necessary surgical intervention or have made arrangements for others to provide for such care and must be able to ensure that patients have access to medical facilities for emergency care.

  1. What information did the FDA consider when it reviewed the Mifepristone REMS Program in 2021?

    To determine whether a modification to the Mifepristone REMS Program was warranted, the FDA conducted a comprehensive review of the published literature, other relevant safety and adverse event data, and information provided by advocacy groups, individuals and the applicants related to the modifications that were under consideration. Our review also included an examination of literature references provided by plaintiffs in the Chelius v. Becerra litigation.

  1. Prior to the FDA’s action in January 2023, how was mifepristone dispensed to patients?

    Prior to the FDA’s action on the REMS modification applications submitted by the applicants for Mifeprex and the approved generic version of Mifeprex, Mifepristone Tablets, 200 mg, the Mifepristone REMS Program required certified prescribers to dispense mifepristone directly to the patient in a clinic, medical office, or hospital. The requirement to dispense directly to the patient in one of these settings was referred to as the “in-person dispensing requirement.”

    There were periods when the in-person dispensing requirement was not being enforced. 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 a lawsuit, ACOG v. FDA filed in the U.S. District Court for the District of Maryland. 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.

    During the periods when the in-person dispensing requirement was not being enforced, the applicants for Mifeprex and the approved generic version of Mifeprex, Mifepristone Tablets, 200 mg, used mail order pharmacies to receive and hold mifepristone on behalf of the certified prescribers who purchased the product. Pursuant to a prescription for Mifeprex or its approved generic, the mail order pharmacy would ship the product to a named patient.

  1. What is the FDA’s role in overseeing the Mifepristone REMS Program?

    As with all REMS, the FDA monitors the applicants’ compliance with the Mifepristone REMS Program, including by reviewing periodic assessment information from the applicants and conducting on-site inspections, and takes action as appropriate.

  1. What is pharmacy certification and why is it a requirement of the Mifepristone REMS Program?

    The Mifepristone REMS Program requires all pharmacies that dispense mifepristone to be specially certified. The pharmacy certification requirement incorporates pharmacies into the REMS, ensures that pharmacies are aware of and agree to follow applicable REMS requirements, and ensures that mifepristone is only dispensed pursuant to prescriptions that are written by certified prescribers. Any pharmacy that meets the requirements of the Mifepristone REMS Program is eligible to be certified. To learn more about pharmacy certification requirements, review the Mifepristone REMS Program documents.

  1. What steps are required for pharmacy certification?

    The pharmacy certification requirement ensures that pharmacies are aware of and agree to follow applicable REMS requirements and ensures that mifepristone is only dispensed pursuant to prescriptions that are written by certified prescribers.

    To become certified to dispense mifepristone, pharmacies must: (1) be able to receive Prescriber Agreement Forms by email and fax; (2) be able to ship mifepristone using a shipping service that provides tracking information; (3) designate an authorized representative to carry out the certification process on behalf of the pharmacy; and (4) ensure the authorized representative oversees implementation and compliance with the Mifepristone REMS Program, which includes, among other requirements, the completion of a Pharmacy Agreement Form.

  1. Is mifepristone available at retail pharmacies?

    The January 2023 modification to the Mifepristone REMS Program removed the restriction that did not allow mifepristone to be dispensed from retail pharmacies. While pharmacy certification is required, any pharmacy that meets the requirements of the Mifepristone REMS Program is eligible for certification.

  1. Is mifepristone available for over-the-counter use?

    No. Mifepristone for medical termination of a pregnancy through ten weeks gestation is currently only available by prescription. An applicant seeking to switch mifepristone for medical termination of pregnancy through ten weeks gestation from prescription to nonprescription (also referred to as over-the-counter) status would need to submit this information to the FDA for evaluation. In order for a drug product to be approved for nonprescription use (including switching a prescription drug product to nonprescription marketing), the applicant must provide sufficient information demonstrating that the drug can be used safely and effectively by consumers without the supervision of a health care provider.

  1. What would be required to remove the REMS?

    The FDA may release a REMS or remove certain components of a REMS, if, after review of REMS assessments or other information, the agency determines that the extra measures in a REMS are no longer necessary to ensure a medication’s benefits outweigh its risks.

Additional Information

  1. Is it possible for an individual to become pregnant again after taking mifepristone for medical termination of pregnancy through ten weeks gestation?

    It is possible for an individual to become pregnant again soon after a pregnancy ends. A patient should consult with their health care provider regarding any specific questions they may have.

  1. Is mifepristone approved in any other countries for medical termination of pregnancy?

    Mifepristone for medical termination of pregnancy has been approved in France since 1988, and also is approved in the United Kingdom, Sweden, and approximately 80 other countries.

  1. Does the FDA set the price of mifepristone and is the drug reimbursed by health insurance providers?

    The FDA does not have the authority to regulate the prices of drug products in the United States. Manufacturers, distributors, and retailers establish the prices. Additionally, the FDA does not have input into or legal control over whether an insurance company does or does not cover the cost of a drug. Insurance coverage is a decision made by an insurance provider. Individuals should contact their insurance provider if they have questions about whether a particular insurance provider will cover the cost of the drug.

  1. Has FDA ever taken action regarding the sale of mifepristone online?

    The FDA has sent warning letters to websites selling unapproved and misbranded mifepristone and misoprostol over the internet, including AidAccess and Rablon.

    There have also been several criminal cases related to the online sale of mifepristone for medical termination of pregnancy. We are aware of three cases about which the Agency can speak publicly. The first is United States v. O’Neil, in the U.S. District Court for the District of Maryland. Information about two more individual prosecutions are available here: March 28, 2017: Former Atlantic County, New Jersey, Man Charged with Smuggling and Dispensing Misbranded Drugs | FDA and here: New York Woman Sentenced for Selling Abortion-Inducing Pills Illegally Smuggled Into US | USAO-WDWI | Department of Justice. The FDA also issued a Final Debarment Order for Ursula Wing, debarring her for a period of five years from importing or offering for import any drug into the United States. This debarment was based on her felony conviction related to her importation and distribution of unapproved and misbranded mifepristone and misoprostol over the internet.

Litigation and Other Legal Issues

  1. Was the Mifepristone REMS Program modified in 2023 in response to the Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization?

    No. The agency’s comprehensive review of the Mifepristone REMS Program, which led to the 2021 decision that a modification was required, is related to the litigation in Chelius v. Becerra. In accordance with the typical process for REMS modifications, the FDA sent REMS Modification Notification letters to the applicants for Mifeprex and the approved generic version of Mifeprex, Mifepristone Tablets, 200 mg. Following receipt of these letters, the applicants prepared a proposed REMS modification and submitted it to their respective applications. The FDA reviewed the REMS modification supplements submitted by the applicants in the Mifepristone REMS Program and approved a REMS modification that removes the in-person dispensing requirement and adds pharmacy certification.

  1. Was the Mifepristone REMS Program modified in 2023 in response to state abortion laws?

    No. See response to Question 29.

  1. What happens if a state refuses to allow mifepristone to be prescribed for medical termination of pregnancy?

    We are coordinating with the Department of Justice and others across the government on these legal issues. Any questions regarding preemption of state law should be directed to the Department of Justice.

  1. What is the status of the Alliance for Hippocratic Medicine lawsuit about the approval of mifepristone?

    On November 18, 2022, the FDA and HHS were sued in the U.S. District Court for the Northern District of Texas by the Alliance for Hippocratic Medicine and other plaintiffs. The agency generally does not comment on pending litigation.

The January 2023 REMS Modification

  1. What action did the FDA take on the Mifepristone REMS Program in January 2023?

    In response to the REMS Modification Notification letters sent on December 16, 2021, to the applicants for Mifeprex and the approved generic Mifepristone Tablets, 200 mg, the applicants submitted supplemental applications to modify the Mifepristone REMS Program to remove the in-person dispensing requirement and add pharmacy certification. The FDA reviewed the applicants’ supplemental applications, as amended, and approved a modification to the Mifepristone REMS Program. Under the Mifepristone REMS Program, as modified, Mifeprex and its approved generic can be dispensed by or under the supervision of a certified prescriber or by certified pharmacies on a prescription issued by a certified prescriber.

    The Mifepristone REMS Program continues to require the Patient Agreement Form and certification of health care providers who prescribe mifepristone.

    The revised REMS document and materials are available on the FDA website at Approved Risk Evaluation and Mitigation Strategies (REMS).

  1. What was the process for approving the current REMS modification?

    In 2021, in order to determine whether a modification to the Mifepristone REMS Program was warranted, the FDA conducted a comprehensive review of the published literature, other relevant safety and adverse event data, and information provided by advocacy groups, individuals, and the applicants related to the modifications that were under consideration. After conducting this review, the FDA determined that the REMS must be modified to remove the in-person dispensing requirement and add pharmacy certification. In accordance with the typical process for REMS modifications, the FDA sent REMS Modification Notification letters to the applicants for Mifeprex and the approved generic version of Mifeprex, Mifepristone Tablets, 200 mg. Following receipt of these letters, the applicants prepared a proposed REMS modification and submitted it to their respective applications. The approved REMS document and materials are available here.

  1. Why did the FDA conduct a review of the Mifepristone REMS Program in 2021?

    REMS require applicants to prepare and submit periodic assessments, which are reviewed by the agency to determine whether the REMS is meeting its goals or whether certain goals or elements of the REMS must be modified.

    The agency’s comprehensive review of the Mifepristone REMS Program, which led to the agency’s December 16, 2021, decision that a modification was required, was related to the litigation in Chelius v. Becerra, as well as to the regular periodic assessments of the REMS. On May 7, 2021, the FDA and the plaintiffs in Chelius filed a joint motion to stay that litigation, which involves the single, shared system REMS for Mifeprex and its approved generic, Mifepristone Tablets, 200 mg. The court granted the stay on May 7, 2021. The Chelius case was reopened on February 28, 2023, and the plaintiffs now challenge the modified Mifepristone REMS Program. The agency generally does not comment on pending litigation.

  1. Was there a change in the reported adverse events during the pandemic when the in-person dispensing requirement was not enforced?

    No. There were periods when the in-person dispensing requirement was not being enforced. 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. The FDA analyzed postmarketing data to determine if there was a difference in adverse events between periods when in-person dispensing was and was not enforced. Based on this review, the agency concluded that there did not appear to be a difference in adverse events between periods when in-person dispensing was and was not enforced.

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