On its 25th birthday, mifepristone is more under attack than ever

Twenty-five years ago today, the Food and Drug Administration approved the use of mifepristone for abortions. Now, the drug is more under threat than ever as anti-abortion Republicans seek to revoke FDA approval of the drug in a bid to further curtail abortion access nationwide.

The first of two drugs used in the standard abortion pill regimen, mifepristone blocks the pregnancy hormone progesterone; the second drug, misoprostol, causes the uterus to contract, expelling the pregnancy. Mifepristone’s FDA approval on Sept. 28, 2000, came more than a decade after the drug was first approved in France, where it was invented.

After it finally was approved in the US, its impact was revolutionary, allowing pregnant people to have abortions in the quiet of their homes, rather than in a clinic, thereby avoiding anti-abortion protesters and opening up access to the procedure as never before.

While mifepristone was originally approved for use up to seven weeks of pregnancy, in 2016, the Obama-era FDA permitted its use through ten weeks’ gestation—although abortion rights activists arguing it is safe later in pregnancy, with the World Health Organization saying it can be used anytime in the first trimester. In December 2021, the Biden administration began allowing abortion drugs to be prescribed remotely rather than in person, a development that has made them even more accessible and less expensive.

Today, despite the Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization that overturned Roe v. Wade, mifepristone’s reach has only grown, thanks to telehealth and shield laws that protect providers in blue states from mailing pills into red states. Medication abortion now accounts for more than 60 percent of all abortions nationwide, according to the abortion rights research and advocacy organization the Guttmacher Institute. One in four abortions are now provided via pills prescribed through telehealth, and half of telehealth abortions last year were provided under shield laws, according to research from the Society of Family Planning.

Anti-abortion Republicans, including some in the Trump administration, have been doing everything they can to try to roll back access to the pills. Their strategy has been to cast doubt on the safety and efficacy of the drugs, even though more than 100 scientific studies have confirmed that mifepristone is safe and effective. As Carrie N. Baker, a Smith College professor and author of Abortion Pills: US History and Politics, told my colleague Nina Martin earlier this year, medication abortion “really is safer than Tylenol.” According to Baker, because of political opposition, the FDA took much longer to approve mifepristone than it did to approve most drugs at the time—”and now, decades later,” she adds, “anti-abortion groups are using the FDA’s [earlier] caution to argue that this drug is unsafe.”

Just this past week, Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary announced that HHS would conduct a new review of mifepristone, after hinting they would do so back in May, as I reported at the time. In their announcement, which reportedly came as a response to a letter Republican attorneys general wrote to Kennedy and Makary back in July, the officials cited a report produced by the Ethics and Public Policy Center, a right-wing organization that was on the advisory board of Project 2025, which claims to have unearthed a higher-than-previously-reported rate of complications from the pills.

Experts have pointed out major flaws with the EPPC’s alleged findings, including the fact that it is not peer-reviewed, fails to fully clarify its methodology, and lacks standardized definitions of terms like “hemorrhage” and “serious adverse events,” which could inflate rates of so-called complications. Even so, abortion opponents promptly embraced the report, which urges the FDA to make the pills more difficult to access and ultimately “reconsider [mifepristone’s] approval altogether.” Sen. Josh Hawley (R-Mo.), for example, asked Makary to “do a complete review” on mifepristone following the report’s publication.

Of course, efforts to reduce access to mifepristone were underway long before the EPPC report’s publication. As my colleague Madison Pauly and I reported back in January, anti-abortion groups sent letters to the Department of Justice and FDA requesting they roll back access to medication abortion by enforcing the 19th-century anti-obscenity Comstock Act, restoring the seven-week gestational limit, and rescinding the Biden-era telehealth regulation. Project 2025, the lengthy playbook for Trump’s second term, also recommended the DOJ enforce the dormant Comstock Act to ban the mailing of abortion pills, though President Donald Trump claimed last year that it was “very unlikely” the FDA would roll back access or that the DOJ would enforce Comstock.

In 2022, an anti-abortion group calling itself the Alliance for Hippocratic Medicine sued in Texas, challenging the FDA’s initial approval of mifepristone as well as the agency’s later moves to expand access. The Supreme Court rejected the suit last year, saying the anti-abortion medical providers didn’t have standing to bring it. But attorneys general in at least six red states, including Texas and Florida, have since intervened in a bid to revive the case. Other suits are trying to curtail access by claiming mifepristone could contaminate drinking water.

There have also been myriad efforts to limit and penalize access at the state level. Last year, Louisiana became the first state to classify mifepristone and misoprostol as controlled substances, a move that one doctor predicted would also impact non-abortion-related care, including postpartum hemorrhages and IUD insertions. This month, Texas enacted a radical bill that allows allows private citizens to sue anyone who “manufactures, distributes, mails, transports, delivers, prescribes, or provides” abortion pills to Texans for at least $100,000. Officials in Texas and Louisiana have sought to punish doctors in New York and California who mailed abortion pills into their states under shield laws. Meanwhile, a handful of blue states with shield laws have sought to strengthen those laws by allowing providers to keep their names off of prescriptions for abortion pills.

Ahead of mifepristone’s 25th birthday, reproductive rights advocates lauded the role the drug has played in helping people take control of their reproductive lives and blasted anti-abortion Republicans for trying to restrict access to it.

“Anti-abortion policymakers and activists are escalating attacks on medication abortion to continue their crusade against abortion for anyone and at any time through shoddy science, medically unnecessary restrictions, and punitive lawsuits and legislation,” said Kelly Baden, vice president of public policy at the Guttmacher Institute. “With abortion already banned or restricted in much of the country, safeguarding access to medication abortion using mifepristone and rejecting calls to reinstate outdated restrictions or revoke approval is critical.”

“As disinformation campaigns continue to try to scare the public, Planned Parenthood will remain unequivocal: Abortion is health care, mifepristone is safe and effective, and everyone deserves the right to make their own decisions about their body,” added Danika Severino Wynn, vice president of care and access at Planned Parenthood Federation of America.

In an op-ed published Sunday with Stat News, Elisa Wells, co-founder of Plan C, a website that provides information about how to access abortion pills, called mifepristone “a transformational and disruptive hero in the fight to modernize abortion access, even in the face of unjust political restriction of care.”

“Even if all of these barriers are put into place,” she added, referring to Republicans’ myriad attacks, “they will not stop access to abortion pills.”