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

Judge’s ruling on mifepristone has no basis in medical science
APR 12, 2023

Jack Resneck Jr., MD
Immediate Past President

     URL: https://www.ama-assn.org/about/leadership/judge-s-ruling-mifepristone-has-no-basis-medical-science
                     Copyright 1995 - 2021 American Medical Association. All rights reserved.

URL: https://www.ama-assn.org/about/leadership/judge-s-ruling-mifepristone-has-no-basis-medical-science
                Copyright 1995 - 2021 American Medical Association. All rights reserved.

AMA News Wire

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

Apr 12, 2023

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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.

    URL: https://www.ama-assn.org/about/leadership/judge-s-ruling-mifepristone-has-no-basis-medical-science
                    Copyright 1995 - 2021 American Medical Association. All rights reserved.

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.

Inflicting irreparable patient harm
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.

A dangerous precedent
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

    URL: https://www.ama-assn.org/about/leadership/judge-s-ruling-mifepristone-has-no-basis-medical-science
                    Copyright 1995 - 2021 American Medical Association. All rights reserved.

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.

    URL: https://www.ama-assn.org/about/leadership/judge-s-ruling-mifepristone-has-no-basis-medical-science
                    Copyright 1995 - 2021 American Medical Association. All rights reserved.