Judge’s ruling on mifepristone has no basis in medical science

AMA News Wire

Judge’s ruling on mifepristone has no basis in medical science

Apr 12, 2023

Editor’s note: The U.S. Supreme Court is hearing oral arguments in this case March 26, 2024. The AMA has been engaged throughout, filing multiple briefs. Learn more about the brief the AMA and 15 other medical associations filed with the high court in this case.

The unprecedented judicial ruling issued April 7 by a federal district court judge in Texas to suspend the use of mifepristone—an extremely safe and effective drug backed by hundreds of studies and used by millions of women—favors ideology and pseudoscience over facts, harms patients, interferes with the patient-physician relationship and jeopardizes public health nationwide.

The AMA and other leaders in medicine are fighting this outrageous ruling as it moves through the court system. The AMA this week joined the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine and others in an amicus brief (PDF) filed with the 5th U.S. Circuit Court of Appeals, arguing that this ruling unnecessarily jeopardizes the health of patients across the country.

This case is yet another example of unconscionable interference with reproductive rights that will have serious consequences for patients nationwide, not just for those in states that have already banned or limited access to abortion. This dangerous ruling also undermines the drug-approval process used by the Food and Drug Administration (FDA) by allowing a single judge to substitute his own views and ideological agenda for the data-driven analysis of clinical evidence by FDA experts.

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 an early pregnancy, as well as to manage miscarriage. This two-drug regimen, known as a medication abortion, 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 last June.

The FDA’s approval of mifepristone was challenged in a lawsuit brought before a federal judge in Texas that sought to make the drug unavailable in any state. The suit—brought by a group of physicians who had never used or prescribed the drug—contended that the FDA wrongly approved mifepristone on an accelerated basis, and erroneously claimed the drug poses serious safety concerns to patients.

In fact, the FDA’s accelerated process has been used for dozens and dozens of other drugs that patients count on every day. The safety and efficacy of mifepristone itself has been conclusively demonstrated by hundreds of medical studies and voluminous data. Studies performed since FDA approval was granted in 2000 show that serious adverse events happen in fewer than one-third of 1% of patients. Ample evidence shows that the risk of death during or after childbirth is about 14 times higher than the risk of death from abortion-related complications.

While there is absolutely no evidence that patients are harmed by access to safe and effective medication abortion, there is abundant evidence that denying this care without justification can inflict a serious physical, psychological and economic toll on them. Eliminating this highly effective medication will not only limit choices for patients, but will also create further strain and lengthen wait times for surgical abortion services.

Mifepristone is also recommended for and is part of a highly effective regimen in managing miscarriages.  Removing access to this standard of care treatment not only causes needless suffering, but also puts women experiencing early pregnancy loss at further risk for infections, hemorrhage, and other life-threatening complications.

Current data shows an association between restricted access to safe and legal abortion and higher rates of maternal morbidity and mortality, with already vulnerable populations experiencing the greatest burden. Reduced access to mifepristone will almost certainly exacerbate the maternal mortality crisis in places that do not have access to this medication, and for historically marginalized racial and ethnic groups and those who have been economically and socially marginalized.

AMA policy supports patients’ access to the full spectrum of reproductive healthcare options, including abortion and contraception, as a right. Our ethical obligation is to help patients choose the optimal course of treatment, through shared decision-making that is fully informed by evidence-based medical science and shaped by patient autonomy. Anything less puts patients at risk and undermines both the practice of medicine and our nation’s health.

The harm to public health posed by an ideologically driven nationwide ban on mifepristone would be immense. But this decision introduces the additional peril of allowing courts to override longstanding drug regulatory decisions made by the FDA. Establishing that type of precedent would subvert the authority granted to FDA by Congress to make these determinations, undermine the integrity of its drug-approval process, and open its previous and future drug approvals to interpretation by judges with no medical or scientific training whatsoever.

Allowing courts to upend drug regulatory decisions by the FDA based on speculation, opinion or ideology goes against the long-established scientific process that leads to those careful decisions and puts every other drug at risk of finding itself subject to similar efforts.

I can scarcely imagine practicing medicine and providing the best care to my patients when individual treatment options that have already passed FDA scrutiny are subject to the whims of individual judges. By rejecting science and undermining sound medical practice, one federal judge has improperly and unnecessarily intervened in highly personal decisions that belong to patients and physicians.

Any rejection of evidence-based medical science undermines informed decisions, erodes trust in institutions, exacerbates social divides, and places individual and collective health at risk. The AMA will continue to fight to support access to evidence-based health care, including abortion medication, and will vigorously oppose all efforts by government or other parties that undermine our patients’ health.