In Alliance, the Supreme Court will review the FDA’s decisions regarding how mifepristone is labeled and distributed, including restrictions on mifepristone that the FDA lifted in previous years after rigorous reviews and research finding that the drug is safe and effective. The case calls into question the FDA’s integrity as a regulatory body and could undermine its authority and purpose as an institution designed to protect public health and safety. This is despite the fact that the FDA undergoes an extensive and stringent review process for all drugs and has reevaluated the safety of mifepristone at least four times in response to new research—each time concluding that it is safe. The FDA, not the judiciary, is tasked with determining the safety of drugs, as it has the expertise to do so. It’s critical that drug approvals be based on science and safety, not politics.
Mifepristone is safe and effective
![Protesters outside the Supreme Court (Getty).]()
Tell the Supreme Court To Protect Abortion Access
This column explores how the FDA’s two most recent decisions on mifepristone reflect the agency’s commitment to medical and scientific expertise, as well as how those decisions contribute to the overall safety of medication abortion and align with standard health care practices. The column also explains how the Alliance case not only threatens to disrupt and stop abortion access nationwide but also represents an attempted upheaval of the regulatory process for all drug approvals by the FDA.
Background
The U.S. landscape of abortion care has undergone a significant transformation since the FDA’s initial approval of mifepristone in September 2000, which enhanced both the safety and accessibility of medication abortion. Among those changes were updates to the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program and the product label following rigorous reviews guided by scientific evidence and medical consensus. Mifepristone has always been safe and effective, and each time the FDA has implemented a REMS or product label update, it has reaffirmed that the drug is one of the safest drugs available on the market.
What is the FDA REMS program?
The Risk Evaluation and Mitigation Strategy (REMS) program is a drug safety and regulatory program established by the FDA in response to the Food and Drug Administration Amendments Act of 2007, which granted the FDA authority to establish REMS programs under specific conditions. The REMS requires certain medications to undergo additional evaluation for safety concerns and makes them subject to restrictions on how they can be dispensed. The agency considers whether the risks of using a certain drug outweigh its benefits and determines if additional measures are required to reduce any associated risks.
A REMS is meant to be used as a resource for providers and to promote safe and effective use of approved medications. In the case of mifepristone, the REMS protocol is so cautiously safe that it can create medically unnecessary barriers to abortion care for both patients and physicians. The FDA very rarely imposes a REMS, and mifepristone is certainly an outlier when compared with other drugs that have REMS programs. In fact, less than 3 percent of FDA-regulated drugs are subject to a REMS, the majority of which are opioids.
Many research and medical professionals have advocated for the end of the Mifepristone REMS Program due to the unnecessary barriers it creates for patients, such as limiting their options for safe, effective, and private abortion care; posing logistic challenges and travel barriers; contributing to delays in care; and restricting patients’ ability to control the timing and preferred place where they take mifepristone. These barriers are particularly burdensome for marginalized communities—including people of color, LGBTQIA+ people, disabled people, and people living in places with a shortage of health care providers—because of medical racism, reproductive coercion, and other forms of discrimination.
Rather than eliminate the Mifepristone REMS Program altogether, the FDA has made more cautious decisions to modify the REMS requirements incrementally over time.
What is the FDA product label?
As part of the approval process for a drug, the FDA also approves a product label that explains what patients need to know about how to use the drug and its indications. As medical research advances and standard medical practices shift, product labels must be updated accordingly. Notably, the product label for mifepristone has undergone multiple changes since its initial approval in 2000 to reflect science and new research.
2016 REMS and product label changes
In March 2016, the FDA implemented an updated Mifepristone REMS Program to ease some restrictions on the drug’s distribution and also made changes to mifepristone’s product label—including reducing the dosage of mifepristone, changing the misoprostol administration requirements, expanding the gestational limit within which the regimen could be used, allowing other qualified health care providers to administer the drug, and adjusting post-treatment medical visit requirements. These changes were highly regarded as a victory for medical professionals and health care providers, as they brought the FDA-approved regimen in line with standard medical practice. Furthermore, they reflected scientific and evidence-based best practices, reaffirming the safety and efficacy of mifepristone.
Change 1: Lowering mifepristone dosage to only what was necessary to be effective
The 2016 label change lowered the recommended dosage of mifepristone from three 200 milligram tablets (600 mg total) to a single 200 mg tablet taken orally. This change was made after a clinical trial suggested a much lower dose was needed to achieve the same results.
Change 2: Changing the administration of misoprostol to extend the period of use and reduce unpleasant side effects
The 2016 label change modified the administration of misoprostol tablets, as part of the second step to medication abortion, from two 400 microgram tablets (800 mcg total) taken orally to four 200 mcg tablets (800 mcg total) that are instead dissolved between the cheek and gum, or buccally. Misoprostol tablets are used 24 to 48 hours after mifepristone is taken. This way of using misoprostol also makes its side effects milder since the drug is absorbed differently by the body. Furthermore, the label no longer required people to revisit their provider in-person to use misoprostol because it could now be taken at home.
Change 3: Extending gestational limits for two-step abortion care in the first trimester
Changing the amount of misoprostol and the way it is used made medication abortion effective for more advanced pregnancies. As such, the FDA extended the approved protocol for a medication abortion to 70 days, or 10 weeks, from the initial approval of 49 days, or seven weeks—accounting for evidence that demonstrates the mifepristone-misoprostol regimen is safe and effective through 10 weeks of pregnancy. This change doubled the number of abortion patients who were eligible for a medication abortion from 37 percent to 75 percent.
Change 4: Broadening mifepristone prescriber eligibility so that other qualified health providers could prescribe medication abortion
The FDA broadened the prescriber certification requirement from being limited to physicians to include other qualified clinicians who meet REMS requirements. This meant that providers with prescriptive authority in states where medication abortion is legal could now prescribe mifepristone. The change reflected the reality that in states where advanced-practice nurses and/or physician assistants are allowed to provide medication abortion, those types of professionals were already the most common provider of care. Research demonstrates that nonphysician professionals can dispense medication abortion just as safely as physicians can.
Change 5: Changing follow-up requirements to reduce barriers to care
To allow for more patient-centered care, the 2016 label changed the timing for patient follow-up after administration of mifepristone from seven days to 14 days. Medical practice does not require a clinical exam to assess abortion completion, and notably, research has shown that women can safely and accurately assess the outcome of their medication abortion without an in-clinic follow-up. This change helped people avoid some of the logistical barriers caused by having to return to the health care facility.
2021 and 2023 REMS changes
During the COVID-19 pandemic, the FDA temporarily halted enforcement of the REMS in-person dispensing requirement for mifepristone for the duration of the public health emergency. The FDA then completed a review of the Mifepristone REMS Program and determined that the temporary modifications helped improve patient access and aligned with long-standing research on the safety of mifepristone. As a result, in 2023, the FDA announced that the change would be permanent.
The most significant changes to the Mifepristone REMS Program made in 2021, and permanently established in 2023, were the removal of the in-person dispensing requirement and the expansion to allow pharmacists to dispense mifepristone.
Change 1: Removing the in-person dispensing requirement
During the public health emergency, the FDA halted enforcement of the REMS in-person dispensing requirement; and in 2023, it formally lifted the REMS requirement, meaning that people no longer had to receive and take mifepristone inside the walls of a clinic, medical office, or hospital, thereby allowing mifepristone to be mailed in states that allow medication abortion via telehealth. Scientific studies had already proven that telehealth medication abortion is safe and effective. Given that a physician exam is not required for the provision of medication abortion, requiring the patient to come into the facility simply to pick up the medications does not enhance patient safety. This change also helped mitigate the burdens of travel and logistical challenges of getting to a clinic to pick up the prescription.
Change 2: Extending dispensing requirements to pharmacists
The second meaningful change made in 2021, and finalized in 2023, was to allow certified pharmacies to dispense mifepristone. Retail pharmacies that met certain requirements and completed a pharmacy agreement form could now dispense mifepristone to patients with a prescription from any certified prescriber. This change broadened who could be certified from abortion-providing clinicians to pharmacies, allowing people to access medication abortion at their local pharmacy or from a mail-order pharmacy in states that allow it.
However, despite the change to the in-person dispensing requirement, prescribers are still required to be certified by the manufacturers. Notably, in March 2024—one year after this change permanently took place—Walgreens and CVS pharmacies announced that they completed certification requirements and would begin dispensing medication abortion in stores.
The FDA has maintained mifepristone safety amid efforts to roll back scientific progress
Mifepristone has always been safe and effective. And with each reevaluation of the Mifepristone REMS Program and the product label, the FDA has reaffirmed the drug’s safety and made it more accessible. These changes, collectively, have contributed to an improved protocol for medication abortion.
It’s critical that drug approvals be based on science and safety, not politics.
The FDA is responsible for protecting public health by ensuring the safety, efficacy, and security of drugs, medical devices, and other products consumed or used in the United States. What the Supreme Court is being asked to do in Alliance is overrule the agency’s authority and ignore almost 30 years of evidence on the safety of mifepristone in the pursuit of far-right extremist, personal ideologies. If the Supreme Court were to reimpose pre-2016 restrictions on mifepristone, those changes would reduce the safety, efficacy, and accessibility of medication abortion overnight. Returning to pre-2016 restrictions would almost immediately suppress access because any rollback of mifepristone’s approval would result in nationwide barriers to care and harm even in states where abortion is legal.
These renewed restrictions would represent a rollback of scientific progress while doing nothing to promote equitable care and access for the millions of women who require abortion care to achieve their family planning goals.
See also
Conclusion
The FDA’s updates to the Mifepristone REMS Program and product label in 2016, 2021, and 2023 each represented significant advancements toward enhancing the safety, efficacy, and accessibility of medication abortion. By adjusting dosage guidelines, eliminating unnecessary visits, and removing the in-person dispensing requirement, the changes reflected the FDA’s commitment to evidence-based decision-making. These modifications not only contributed to the overall safety of medication abortion but also aligned with standard medical and health care practices. Reinstituting any restrictions would be a detriment to scientific progress. Continued efforts to expand access and prioritize patient safety will further strengthen the role of medication abortion as a crucial component of reproductive health care.
The author would like to thank Sabrina Talukder, Bela Salas Betsch, Tracy Weitz, Lily Roberts, Andrea Ducas, and Emily Gee for their reviews of and contributions to this column.