Advocacy and Health Policy |
Understanding the Practical Implications of the FDA’s December 2021 Mifepristone REMS Decision
A Q&A with Dr. Nisha Verma and Vanessa Wellbery
On December 16th, 2021, the US Food and Drug Administration (FDA) issued a decision to change its labeling for mifepristone after conducting a review of its risk evaluation and mitigation strategy (REMS) for the drug. This Q&A with Dr. Nisha Verma, a fellow of ACOG and complex family planning subspecialty trained OB/GYN, and Vanessa Wellbery, ACOG’s Senior State Government Affairs Manager, sheds light on what the FDA decision means and how it may affect clinical practice.
What are the reproductive health indications for the medication mifepristone?
A combined mifepristone and misoprostol protocol is used in reproductive health settings as:
- A safe and effective regimen for medication abortion. Taking medications to terminate a pregnancy, rather than a procedure, is approved by the FDA through 70 days of gestation, but evidence also exists to support safe and effective use with more advanced gestations. i
- Safe and effective management of early pregnancy loss. ii
ACOG supports the use of and expanded access to mifepristone for these indications and opposes restrictions such as on-site dispensing requirements and mandatory in-person exams prior to and following a medication abortion. iii,iv,v
What is the REMS?
The FDA has the authority to require a Risk Evaluation and Mitigation Strategy (“REMS”) for the dispensing of a drug. A REMS is applied to drugs when the FDA deems it “necessary to ensure that the benefits of the drug outweigh the risks.” The FDA also has the authority to lift a drug’s REMS based on an evaluation of safety data. vi
The FDA restricted the distribution of mifepristone upon its approval in 2000, and then established a REMS for mifepristone in 2011. Until December 16, 2021 the REMS for mifepristone had three elements:
- Mifepristone could only be administered in a clinic, hospital, or under the direct supervision of a certified medical provider. Referred to as the “in-person dispensing requirement,” this precluded availability in retail pharmacies and delivery by mail, even though patients were not required to use mifepristone at the time it was dispensed in the clinician’s office and could take it at home.
- A clinician must obtain certification by submitting a Prescriber Agreement Form to the drug distributor prior to prescribing mifepristone.
- The patient must sign an FDA-approved Patient Agreement Form before a clinician can dispense the drug.
ACOG has long opposed the REMS for mifepristone. Decades of evidence and the consensus of the medical community underscore that mifepristone is a safe medication, the FDA requirements do not benefit patients, and the FDA requirements disproportionately burden communities already facing structural barriers to care, including people of color and those living long distances from a health care professional.
How did the REMS for mifepristone change during the COVID-19 pandemic?
When the COVID-19 pandemic began, ACOG petitioned the FDA in court for removal of the burdensome and dangerous in-person dispensing requirement. As a result, the FDA halted enforcement of the in-person dispensing requirement for mifepristone for the duration of the COVID-19 public health emergency, which is ongoing. vii Because enforcement of this requirement was halted, clinicians in multiple states have been able to provide mifepristone to patients by telemedicine and mail. viii Of note, state laws regulating medication abortion remain in effect despite these temporary changes to REMS enforcement.
What did the FDA’s December 2021 decision say?
On December 16, 2021, the FDA issued permanent modifications to the REMS. This decision:
- Removed the in-person dispensing requirement.
- Added a requirement that pharmacies which dispense mifepristone must be certified.
- Maintained the prescriber certification and Patient Agreement Form requirements.
When will the FDA’s December 2021 decision go into effect?
Currently, the manufacturers of mifepristone are preparing proposals for the implementation of the REMS modifications, which will be submitted to the FDA. Once these submissions are received and approved by the FDA, the December 2021 REMS modifications will go into effect. Specific guidance about implementation of the FDA’s December 2021 decision is not available at this time.
Of note, the COVID-19 public health emergency is ongoing, and therefore the enforcement of the in-person dispensing requirement for mifepristone remains suspended. ix All other REMS requirements are in effect.
How will the change to FDA’s labelling of mifepristone affect clinical practice in my state?
Whether clinicians can dispense mifepristone by mail is a state-specific legal question. If your state has a law regulating medication abortion, it remains in effect.
However, in states without laws or regulations requiring in-person dispensing of mifepristone, clinicians who are certified via the provider agreement form can mail mifepristone to patients. The Guttmacher Institute provides resources reviewing state laws and policies related to medication abortion and abortion in general, which may be useful for clinicians seeking more information. Clinicians can also seek legal counsel to clarify state restrictions or laws regarding mifepristone.
If you have questions about state policies impacting access to medication abortion, you can reach out to ACOG’s State Government Affairs team ([email protected]) to discuss further. If you have other questions about the use of mifepristone or medication abortion, you can submit an inquiry through ACOG’s Spontaneous and Induced Abortion Resource Center.
As a reminder, this message is for informational purposes only and should not be construed as legal advice on any subject matter. As a practitioner, neither you nor anyone who reads this message, should act or refrain from acting on the basis of any content included in this message, or on ACOG’s website without seeking legal or other professional advice.
i Medication abortion up to 70 days of gestation, Practice Bulletin No. 225 (October 2020)
ii Early Pregnancy Loss, Practice Bulletin No. 200 (November 2018)
iii Increasing Access to Abortion, Committee Opinion No. 815 (December 2020)
iv Improving Access to Mifepristone for Reproductive Health Indications, Position Statement (June 2018)
v The FDA’s Decision Lifting the Burdensome Restriction on Mifepristone during the Pandemic: What You Need to Know Advocacy and Health Policy, web-only document (April 2021)
vi An introduction to risk evaluation and mitigation strategies, Contraception VOLUME 104, ISSUE 1, P4-7, JULY 01, 2021.
vii ACOG Suit Petitions Court to Remove FDA's Burdensome Barriers to Reproductive Care During COVID-19 Advocacy and Health Policy web-only document (May 2020)
viii Expansion of a direct-to-patient telemedicine abortion service in the United States and experience during the COVID-19 pandemic, Contraception (March 2021)
ix Questions and Answers on Mifeprex, US Food and Drug Administration (December 2021)