25 years after its approval, the abortion drug Mifepristone is still under attack

It’s been 25 years since the U.S. Food and Drug Administration first approved mifepristone, the abortion pill that changed the landscape of reproductive health in the United States,, offering a safe, accessible, and more private option than a surgical procedure. 

According to the Guttmacher Institute, as of 2023, medication abortion, most commonly in the form of a two-pill regimen of mifepristone followed by misoprostol, accounted for 63% of all abortions provided within the U.S. health care system in states in which abortion is legal, up from about 53% in 2020. Guttmacher noted that regulation changes finalized in January 2023 made it possible for patients to obtain the medication through the mail, without an in-person appointment, broadly increasing access. 

Mifepristone, which remains accessible in all 50 states, even those with abortion bans via telehealth and mail-order services, is approved for abortion through 10 weeks’ gestation, and the safety of the drug is well-established, with rare complications. 

But even after a quarter-century of use, mifepristone remains under attack through legal challenges, regulatory threats, misinformation, and state restrictions. 

In August, Texas and Florida asked to join a lawsuit in which Idaho, Missouri, and Kansas had earlier intervened after the Supreme Court dismissed for lack of standing an earlier case brought against the FDA to restrict mifepristone.

The two states argued a need to join State of Missouri et al. v. U.S. Food and Drug Administration et al. to protect themselves from other states’ shield laws. Such statutes, enacted in at least eight states, protect telehealth providers who prescribe abortion drugs to patients in states where they are banned. That case, in the U.S. District Court for the Northern District of  Texas, under Judge Matthew Kacsmaryk, is in process.

On Sept. 3, the Texas Senate passed House Bill 7, which, if signed by Gov. Greg Abbott, will allow private citizens to sue any person who violates provisions in the bill that state, “A person may not: (1) manufacture or distribute an abortion-inducing drug in this state; or (2)mail, transport, deliver, prescribe, or provide an abortion-inducing drug in any manner to or from any person or location in this state.” The bill contains exceptions that include the provision of medication in cases of medical emergencies, ectopic pregnancies, spontaneous abortion, or “a purpose that does not include performing, inducing, attempting, or assisting an abortion, other than an abortion performed in response to a medical emergency.”

The law will offer a reward of at least $100,000 to “a woman who was pregnant at the time the woman obtained or received an abortion-inducing drug” in violation of the law and the “father, sibling, or grandparent of the unborn child.” If the person is not related to the pregnant person, then the reward is just $10,000, with the remaining $90,000 earmarked for a charity of the person’s choice. The pregnant woman herself cannot be sued.

“This bill will harm women and could even lead to more pregnant women dying because they couldn’t access life-saving medications,” Democratic Texas Rep. Donna Howard said on the Texas House floor, the Texas Observer reported. “The only reason we haven’t returned to the days of [pre-Roe v. Wade] ‘coat-hanger abortions’ is because of the medication abortion pill. I ask you: ‘When will this be enough? How many women have to die or suffer severe bodily injury because they couldn’t access the care they needed?’”

Abbott is expected to sign the bill into law on Sept. 28, the 25th anniversary of the drug’s approval. 

In early September, Health and Human Services Secretary Robert F. Kennedy Jr. suggested that access to mifepristone could be rolled back, accusing the administration of President Joe Biden of falsifying data: “We know that during the Biden administration, they actually twisted the data to bury one of the safety signals, a very high safety signal, around 11%” Kennedy said during a hearing of the Senate Judiciary Committee on Sept. 4, the Guardian reported. “We’re gonna make sure that doesn’t happen anymore.” The Guardian noted that Kennedy appeared to be basing his statement on a non-peer-reviewed paper published by a right-wing think tank.

Reproductive health researchers and medical associations, as well as pharmaceutical companies, have called on the FDA to protect the medication. 

“Decades of conclusive scientific evidence amassed through more than one hundred rigorous studies based on hundreds of thousands of patient outcomes have overwhelmingly established the safety and effectiveness of mifepristone for medication abortion and management of early pregnancy loss,” reads a letter published by the UCLA Law Center for Reproductive Health, Law, and Policy, and University of California San Francisco Advancing New Standards in Reproductive Health and signed by 263 researchers in reproductive health.

Democratic-led states New York, Maine, Massachusetts, Vermont, and Washington have recently gone further than simply passing shield laws and enacted laws that allow health care providers to send abortion pills to patients in states with abortion bans anonymously. A similar bill in Pennsylvania is currently in committee. On Sept. 11, California passed its version, Assembly Bill 260, in the State Assembly and the Senate, and Gov. Gavin Newsom is likely to sign it.