Reducing access to mifepristone would harm patients

Jack Resneck Jr., MD , Immediate Past President

Preserving access to mifepristone—an exceedingly safe and effective prescription drug approved by the Food and Drug Administration (FDA)—will protect patients and allow physicians to continue to provide medically appropriate care that is firmly rooted in evidence-based science.

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Reimposing unnecessary limits on mifepristone, which is used in the two-drug protocol for medication abortion and miscarriage management­, will jeopardize public health and significantly worsen inequities in maternal health for people of color, those with low incomes and those living in underserved communities.

That is the message delivered by the AMA and 15 other leading medical societies in an amicus brief (PDF) filed with the U.S. Supreme Court, as the justices prepared to hear oral arguments about mifepristone access on March 26. This case involves a ruling issued in August 2023 by a three-judge panel of the 5th U.S. Circuit Court of Appeals in a lawsuit brought against the FDA by anti-abortion organizations and doctors who have never prescribed the pill.

The appeals court ruling would allow mifepristone to remain on the market. But it also restores outdated restrictions on mifepristone use that the FDA removed years ago after thorough reviews of extensive evidence. These include requiring patients to pick up the medication in person, unnecessarily visit a physician three times during the process of a medication abortion, and labeling the drug for use only through seven weeks’ gestation. If allowed to stand, the appeals-court decision would have devastating health consequences for people living in states where abortion is still legal by eliminating the ability to be prescribed mifepristone for medication abortion via telehealth and receive it through a mail-order pharmacy. Forced pregnancy and denial of abortion care have been shown to lead to worse health and economic outcomes for women and increased exposure to intimate partner violence.

The role of mifepristone in the practice of medicine extends well beyond its use in medication abortion. Nearly one in every five patients who become pregnant will experience a miscarriage, and mifepristone is commonly used for the management of pregnancy loss. Restricting its use will also exacerbate the physical and emotional strains for those women enduring a miscarriage, forcing them to use less effective treatments or suffer through up to two months of drawn out, more severe symptoms. 

If the U.S. Supreme Court allows ideologically driven plaintiffs and judges without medical or scientific training to override our nation’s long-established drug-approval process, further chaos will likely ensue as challenges are brought against other FDA-approved drugs that physicians and our patients rely on every day.

Approved by the FDA more than two decades ago, mifepristone is a safe and effective progesterone-blocking prescription drug that is administered in combination with a second drug, misoprostol, to terminate early pregnancies and to manage miscarriages. This two-drug regimen now accounts for more than half of all abortions in states where terminating a pregnancy remains legal following the U.S. Supreme Court’s Dobbs decision in 2022.

Hundreds upon hundreds of peer-reviewed clinical studies and decades of evidence-based research disprove the assertions of the plaintiffs in this case and demonstrate the safety of mifepristone, which has a safety profile comparable to ibuprofen. Studies performed since FDA approval was granted in 2000 show that serious adverse events occur in fewer than one-third of 1% of patients.

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It is rare for a patient to experience even a minor complication from a medication abortion, and the risk of death is so small (PDF) as to be nearly nonexistent. Continuing a pregnancy poses far greater danger; the risk of death during or after childbirth is approximately 14 times higher than the risk of death from abortion-related complications. People of color (particularly Black women), those with low incomes, and those living in rural areas face the greatest risk of severe maternal morbidity. Additionally, pregnant people of color are more likely to experience miscarriage, for which mifepristone is part of the most effective treatment regimen.

After the FDA acted on sound scientific evidence and removed unnecessary restrictions on mifepristone by revising its guidelines in 2016 and 2021, the result was enhanced quality and wider availability of essential reproductive care. Millions of patients, making complex decisions in collaboration with their physicians and in line with their personal values, continue to be better served by these adjustments.

The data demonstrate that there is no medical justification or benefit for requiring a patient who has taken mifepristone to complete two follow-up visits to a physician’s office or health center. This mandate effectively ruled out the option for a medication abortion for those patients living in areas with few or no health professionals, or whose personal circumstances otherwise made compliance with rules on in-person visits difficult or impossible to achieve.

The greater availability of telehealth services, combined with distribution of mifepristone by mail, has been demonstrated to be safe and effective and continues to expand access to reproductive care. And of course, patients who prefer to see their physician in person retain that option.

Turning back the clock on the use of mifepristone by restoring previous restrictions without any credible scientific basis favors ideology and pseudoscience over facts, harms patients, interferes with the patient-physician relationship and jeopardizes public health. Reimposing those limits undermines the scientific, evidence-based approach of the FDA and places pregnant people at greater risk, which is why we urge the nation’s highest court to put the health of patients above ideology.