A lawsuit filed in November 2022 by anti-abortion advocates against the U.S. Food and Drug Administration (FDA) and the U.S. Health and Human Services (HHS) may remove an abortion medication from the market in all 50 U.S. states.
Anti-abortion groups are suing the FDA over its initial approval of mifepristone, one of the drugs used in medication abortion. Filed in a federal district court in Texas, the lawsuit, Alliance for Hippocratic Medicine v. FDA, is seeking to revoke FDA approval of mifepristone and remove it from the market nationwide. If the court grants the plaintiffs’ request, access to the most common medication abortion regimen would end across the country—even in those states where abortion rights are protected.
“In a nutshell, this case is an attempt to have a nationwide ban on medication abortion,” says Jenny Ma, senior counsel at the Center for Reproductive Rights.
The FDA, in response to the lawsuit, claimed, “The public interest would be dramatically harmed by effectively withdrawing from the marketplace a safe and effective drug that has lawfully been on the market for twenty-two years.” In the U.S., medication abortion accounts for more than half of all abortions.
“Overturning Roe v. Wade was just the beginning for the anti-abortion movement in the United States,” said Ma. “For years, anti-abortion advocates claimed that abortion should be left to each state—but it’s clear that their real goal was always to ban abortion nationwide.”
“The intent of this lawsuit has always been to ban medication abortion in the U.S.—and it is part of anti-abortion extremists’ agenda to make all abortion care impossible to access.” —Jenny Ma, senior counsel at the Center
Leading Medical Organizations Support Medication Abortion
Leading medical organizations—including the American Medical Association (AMA) and the American College of Obstetricians and Gynecologists (ACOG)—have repeatedly expressed concern over the lack of access to abortion on patients’ health.
ACOG and the AMA predict that that the country’s maternal mortality crisis will worsen without access to abortion care, including medication abortion. In a statement, pharmacist organizations raised concerns about the risks to patients’ health without access to mifepristone, which is also used to treat ectopic pregnancies, miscarriages, and other medical conditions.
In addition to endangering access to medication abortion, the lawsuit also threatens the FDA’s authority over the drug approval process, which could severely limit the development of new drugs overall and have far-reaching repercussions on patients’ access to FDA-approved medications.
Alliance for Hippocratic Medicine v. FDA was filed in November in federal district court in Amarillo, Texas, by the Alliance Defending Freedom (ADF), a conservative legal group that has helped write state anti-abortion laws. After briefing in the lawsuit is completed on February 10, the court could issue its decision at any time. The judge expected to rule on the case is known for his conservative opinions.
“A single district court judge in Texas—a state that already has banned all abortion—could be issuing a ruling that would throw access to medication abortion into chaos, and that would have devastating effects,” Ma said.
The Facts: Medication Abortion is Safe and Effective
Medication abortion was approved by the FDA in 2000 and has since been used by more than 5 million women in the U.S. It has a well-documented safety record, demonstrated in real-world use and in more than 100 research publications in peer-reviewed journals.
- The FDA has conducted in-depth analyses on mifepristone over the years which repeatedly demonstrate the drug’s safety and efficacy, including during initial approval in 2000, follow-up review in 2016, and as recently as this year.
- The FDA’s decision to allow patients to obtain medication abortion via mail was made after a comprehensive review in line with evidence.
- Medication abortion accounts for more than half (54%) of all abortions in the U.S and is the preferred method for many patients.
- Leading medical and scientific organizations, including the American Medical Association (AMA), the American College of Obstetricians and Gynecologists (ACOG), and the American Academy of Family Physicians (AAFP), recognize medication abortion care as safe and effective.
- A robust audit by the Government Accountability Office in 2008 found that the FDA’s approval of mifepristone was consistent with the approval of other drugs.
See “The Safety of Medication Abortion Care,” published by the Expanding Medication Abortion Access (EMAA) Project, for more information.