Editor’s note: The AMA in June applauded the court’s unanimous ruling that preserves access to mifepristone.
“Efforts to second-guess the FDA’s scientific judgment and roll back access to mifepristone were based on a sham case that not only lacked standing, but relied on speculative allegations and ideological assertions to undermine decades of rigorous scientific review proving the drug is highly safe and effective for both termination of pregnancy and for medical management of miscarriage,” said Bobby Mukkamala, MD, the AMA’s president-elect.
What’s the news: The U.S. Supreme Court is set to hear oral arguments next week in a case that will affect health care for millions of women as the justices decide the fate of mifepristone, a safe and effective medication that was approved by the Food and Drug Administration (FDA) 24 years ago.
The AMA has joined 15 leading medical societies representing hundreds of thousands of physicians and other clinicians nationwide in an amicus brief (PDF) telling the court about the safety and efficacy inherent within FDA’s approval of mifepristone, and how access to mifepristone is essential in caring for patients. More broadly, the AMA has also expressed concern about this type of judicial activism against FDA-approved drugs that would undermine access to other lifesaving treatments.
The AMA joined the American College of Obstetricians and Gynecologists, Society for Maternal-Fetal Medicine, American Academy of Family Physicians, American Gynecological & Obstetrical Society, American Society for Reproductive Medicine and American Academy of Pediatrics and other organizations to jointly file the brief in the case, Food and Drug Administration et al. v. Alliance for Hippocratic Medicine et al.
The case, scheduled for oral arguments March 26, comes to the nation’s highest court on appeal from the 5th U.S. Circuit Court of Appeals. That court sided with groups that filed the lawsuit challenging the FDA’s initial approval of the drug more than 20 years ago, as well as subsequent actions that increased access to the mifepristone. The Alliance for Hippocratic Medicine filed the lawsuit on behalf of itself and member groups such as the Catholic Medical Association, the Christian Medical and Dental Associations, and others that oppose abortion.
This marks the first abortion-related case to be considered on the merits by the Supreme Court since its ruling in Dobbs v. Jackson Women’s Health Care Organization (PDF) in 2022.
Why it matters: If the Supreme Court upholds the 5th Circuit’s ruling, patients and physicians across the nation will lose access to mifepristone under the conditions already deemed appropriate by the FDA. Mifepristone is a medication that, used in combination with misoprostol, is the standard of care to provide a safe and effective way to end a pregnancy or manage a miscarriage. Between 10% and 26% of the 5.5 million pregnancies in the nation each year end in miscarriage, the AMA and others tell the court in their brief.
The drug is also used for those experiencing bleeding or hemorrhaging during certain serious pregnancy complications and is increasingly being used in patients being treated for conditions other than pregnancy, including uterine fibroids and endometriosis.
Mifepristone can save lives and evidence shows that using it results in a major adverse event in less than 0.32% of patients, according to the brief. The brief takes issue with a federal Texas district court’s conclusion that the FDA’s loosening of restrictions “resulted in many deaths.” Physicians say that is “simply not true.”
“The statistics on which the District Court relied, and the Fifth Circuit impliedly endorsed, are taken entirely out of context, at best, and plainly wrong, at worse,” the brief says. “Mifepristone is not just safe—it is far safer than countless other medications and among the safest medications or devices approved by FDA and being used in medical practice. Mifepristone has a safety profile comparable to that of ibuprofen, which more than 30 million American take in any given day.”
The brief urges the Supreme Court to “not turn back the clock to deprive patients of safe and effective modern medicine” and further tells the court that the drug should be allowed to continue to be prescribed through telemedicine.
Just because patients lack a local physician would not be the basis deny them a prescription of ibuprofen, the brief notes, adding that “it should not be a basis to deny them another medication that is just as safe because it is used for reproductive care.”
Moreover, the brief says, “speculation that removing the in-person dispensing requirement from mifepristone labeling increases risk to patients smacks of fearmongering, not facts.”
Restricting access to mifepristone will harm pregnant patients, patients who are at least 14 times more likely to die during childbirth than during any abortion procedure and are at an increased risk of experiencing hemorrhage, infection and injury to other organs during pregnancy and childbirth. The dangers of pregnancy are even greater for people from historically marginalized racial and ethnic groups, those with low incomes and people who live in rural areas.
The brief says, “reimposing unnecessary restrictions on mifepristone will exacerbate these existing inequities and pose the greatest danger to those who are already the most poorly served by our maternal health system.”
Learn more: When this case surfaced in 2022, the AMA quickly filed several joint amicus briefs supporting access to mifepristone. In an op-ed published in The New York Times, AMA Immediate Past President Jack Resneck, MD, explained how the stakes extend beyond medication abortion.
“In seeking to restrict access to abortion across the United States, the plaintiffs in this case have, intentionally or not, seriously jeopardized our nation’s 85-year-old drug regulatory system,” Dr. Resneck wrote. “We must be cleareyed; upholding any parts of the district court’s dangerous ruling would in all likelihood almost immediately prompt challenges to other longstanding safe and effective FDA-approved drugs that doctors and patients rely on every day.”
Visit AMA Advocacy in Action to find out what’s at stake in protecting reproductive health care and other advocacy priorities the AMA is actively working on.
