Public Health

AMA to court: Don’t overturn FDA approval of mifepristone

Tanya Albert Henry , Contributing News Writer

The AMA has joined leading medical and public health associations to detail in federal court the safety, efficacy and importance of mifepristone in protecting pregnant patients’ health, as well as the health of patients being treated for conditions other than pregnancy.

Your Powerful Ally

The AMA helps physicians build a better future for medicine, advocating in the courts and on the Hill to remove obstacles to patient care and confront today’s greatest health crises.

A federal judge in Texas is holding a hearing Wednesday in a lawsuit that challenges the approval of the drug, by the Food and Drug Administration (FDA), more than 20 years ago. The Alliance for Hippocratic Medicine filed the suit on behalf of itself and member groups such as the Catholic Medical Association, the Christian Medical and Dental Associations, and others that oppose abortion.

The lawsuit claims that the FDA’s initial approval process for mifepristone was inappropriate and that the agency didn’t protect the health and safety of women and girls. If the judge agrees and grants a nationwide preliminary injunction, patients across the country would lose access to the medication used for patients experiencing miscarriages, choosing medication abortions, experiencing bleeding or hemorrhaging during certain serious pregnancy complications, being treated for Cushing’s Syndrome and other existing and growing treatments not related to pregnancy.

“Plaintiffs have taken a position that is fundamentally ideological, not scientific. … Their request is not based on rigorous scientific review and analysis but on speculation and the personal opinions of two physicians,” the AMA and others tell the court in their amicus brief in the case, Alliance for Hippocratic Medicine et al. v. U.S. Food and Drug Administration et al.

If the court reverses the FDA’s mifepristone approval, it would cause “profound and irreparable harm to patients across the country,” the brief warns.

In addition to the AMA, 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 a half dozen other organizations jointly filed the brief.

Related Coverage

AMA holds fast to principle: Reproductive care is health care

The most common medication abortion in the U.S. is a two-drug regimen where mifepristone is used with misoprostol to end an early pregnancy. The treatment is used to induce abortion and manage miscarriage or early pregnancy loss, which can be life threatening.

The brief tells the court that mifepristone is one of the most studied medications prescribed in the nation and that the scientific evidence supporting its safety and efficacy is “overwhelming” and “on par with common painkillers like ibuprofen and acetaminophen” that more than 30 million Americans take daily.

The drug has been discussed in more than 780 medical reviews and used in more than 630 published clinical trials, of which more than 420 were randomized controlled studies. Evidence shows:

  • Major adverse events are “exceedingly rare,” occurring in about 0.3% of cases.
  • Between 0.014% and 0.07% of patients experience serious infection.
  • The risk of patient death from medication abortion is near zero.

“Plaintiffs point to no sound scientific evidence to support their arguments, relying instead on anecdotes, unsupported theories and speculation,” the brief says.

Related Coverage

Ambiguous anti-abortion laws are putting patients at risk

Abortion care can be lifesaving, especially for people who have serious health conditions or who are experiencing early pregnancy loss, the brief tells the court.

Evidence shows patients are at least 14 times more likely to die of complications during childbirth than during any abortion procedure. They are also at higher risk of experiencing hemorrhage, infection and injury to other organs during pregnancy and childbirth. And substantial evidence shows that denying abortion care puts patients at an increased risk for violence from intimate partners and it exacerbates patients’ economic hardships.

Medication abortion makes the medical care more accessible to patients, including patients who have been economically or socially marginalized, or who come from historically marginalized racial and ethnic groups. Patients in these groups are most likely to experience severe maternal morbidity and increased mortality from pregnancy-related complications.

“Making mifepristone unavailable nationwide—even in states where abortion remains legal—will impose a severe, almost unimaginable cost on pregnant people throughout the United States,” says the brief joined by the AMA.