21 Years After FDA Approval, Abortion Pill Is More Critical Than Ever

With the Supreme Court poised to overturn Roe v. Wade, the fight for access to the abortion pill has become a matter of life and death.

Twenty-one years ago, the U.S. Food and Drug Administration (FDA) approved the abortion pill mifepristone for distribution in the United States. As states are now passing laws to ban abortion and the U.S. Supreme Court is poised to overturn Roe v. Wade, the abortion pill is what will make a post-Roe world very different from the pre-Roe world, when thousands of women died each year from illegal abortions, and many more were left permanently harmed by unsafe and illegal abortions.  

Abortion pills are safe and effective, widely accessible online and easy to use. A grassroots movement led by the organization Plan C is now working to ensure that women across the country know how to get abortion pills and how to use them.

On the 21st anniversary of FDA approval of the abortion pill, now is a good time to remember the courageous and tenacious people who fought for decades to make this life-saving medication possible.

How Did We Get the Abortion Pill?

The abortion pill mifepristone used in combination with another medication—misoprostol—can safely and effectively end a pregnancy. Mifepristone interrupts the flow of the hormone progesterone that sustains a pregnancy and misoprostol causes contractions to expel the contents of the uterus.

The French company Roussel-Uclaf developed mifepristone, known as RU-486, in 1980. Chemist Georges Teutsch first synthesized mifepristone and endocrinologist Étienne-Émile Baulieu arranged tests of its use for medical abortion. After extensive testing, the company applied for and obtained the French government’s approval in 1988 for the drug to be used for abortion. 

The same year, anti-abortion protests in France caused Rousel-Uclaf’s owner Hoechst AG of Germany to stop distributing mifepristone. The French government responded by ordering Roussel-Uclaf to resume selling the medication in the interest of public health.

French Health Minister Claude Évin famously explained at the time, “I could not permit the abortion debate to deprive women of a product that represents medical progress. From the moment government approval for the drug was granted, RU-486 became the moral property of women, not just the property of a drug company.”

Great Britain approved mifepristone for abortion 1991 and Sweden in 1992. But due to pressure from anti-abortion groups, including the U.S. National Right to Life Committee, Roussel-Uclaf and Hoechst AG declined to bring the drug to the U.S. market for fear of boycotts and lost profits. Instead, the company donated all rights for medical uses of mifepristone in the U.S. to the Population Council—a nonprofit that conducts international research on reproductive health.

The Population Council then tried to find a large drug company willing to develop the drug for the U.S. market. After threatened boycotts from anti-abortion groups, large drug companies refused, so in 1995, the Population Council gave the rights to distribute mifepristone to a small company named Danco Laboratories, formed specifically for this purpose. Danco then sought FDA approval of the drug for distribution in the U.S.

While widely known as an abortion pill, mifepristone is very effective for treating fibroids and may also be effective for treating endometriosis and depression. But politically motivated FDA restrictions limit access. (Robin Marty / Flickr)

After a long fight by anti-abortion activists to block the drug from the U.S. market, the FDA approved mifepristone for use within the U.S. in 2000, but placed the drug under a regulatory restriction called Subpart H, later called the Risk Evaluation and Mitigation Strategy (REMS) drug safety program.

Under this restriction, the FDA prohibited retail pharmacies from stocking and distributing mifepristone, instead requiring mifepristone to be dispensed in a doctor’s office, clinic or hospital registered with the drug manufacturer. The FDA allowed use of mifepristone only in the first seven weeks (or 49 days) of pregnancy and required patients to take the medication in the doctor’s presence. This meant patients had to make three visits to their healthcare providers to obtain the medication.

At the time they approved the drug in 2000, the FDA refused to reveal the names of the manufacturer or the FDA employees involved in approving the drug, citing fear of anti-abortion violence. The threats were so serious the agency had to increase security at its offices.

Evidence accumulated about the safety and efficacy of the abortion pill, but the medication remained heavily restricted, although advocates and medical professionals called for the FDA to remove its restrictions on the drug.

In 2016, during the final days of the Obama administration, the FDA finally loosened restrictions on mifepristone by extending the time period during which the drug could be used to 10 weeks (or 77 days), allowing a lower dose of the drug (from 600 mg to 200 mg)—meaning fewer side effects—and allowing fewer visits to the doctor. 

Also in 2016, the FDA approved a research study on telemedicine abortion a research exception to the REMS restriction called TelAbortion, run by Gynuity Health Projects. Under the study, clinicians are able to provide medication abortion care by videoconference and mail the pills to patients.

Despite the ongoing FDA restrictions on mifepristone, the use of medication abortion has increased significantly over time. In 2017, mifepristone accounted for approximately 40 percent of all recorded abortions and 60 percent of abortions performed up to 10 weeks gestation—although the rate is likely higher because of self-managed abortion, which is not recorded.

While widely known as an abortion pill, mifepristone is very effective for treating fibroids and may also be effective for treating endometriosis and depression. Yet the drug is not available to use for these serious conditions because of the politically motivated REMS restrictions, which have made research on its usefulness in treating these conditions difficult to conduct.

Advocates Demand More Access to Abortion Pill

Reproductive health advocates argue that the REMS restriction is based on politics, not medical evidence. Whereas REMS is meant to restrict dangerous drugs, mifepristone is an extremely safe drug. In fact, mifepristone is six times safer than Viagra—which the FDA does not restrict under the REMS program. 

Advocates are pursuing multiple strategies to challenge the REMS restriction, including challenging the FDA restrictions in court, lobbying the FDA to remove the restrictions, reinterpreting the REMS restrictions to be less restrictive, expanding the TelAbortion research exemption to the REMS restriction, and supporting self-managed abortion.

When COVID hit, the Trump administration lifted FDA restrictions on most drugs so patients could access them without in-person visits to doctors, but not the abortion pill. So advocates and health care providers sued. In July of 2020, a Maryland federal court ruling suspended the FDA requirement that patients make in-person visits to medical providers to get the abortion pill. U.S. District Court Judge Theodore Chuang ruled the FDA requirement of in-person visits during the pandemic imposed a “substantial obstacle” to abortion health care that is likely unconstitutional. Judge Chuang’s order allowed doctors to mail mifepristone to their patients. 

But the Trump administration appealed the ruling all the way to the Supreme Court, twice. The second time, on January 13, 2021, six members of the Supreme Court granted a Trump administration request to reinstate an FDA rule requiring patients seeking medication abortion to make an unnecessary in-person visit to their health care provider just to pick up the medication and sign a form. Justices Sotomayor, Kagan and Breyer dissented.

With President Joe Biden in office, the FDA issued new guidance on April 12 lifting a restriction on mifepristone for the duration of the COVID-19 public health emergency. Then on May 7, the Biden administration announced that the FDA would undertake a review of the REMS restrictions on mifepristone. The announcement came as part of a joint legal filing in the ACLU lawsuit Cheslius v. Becerra, challenging the restrictions.

But while the FDA now allows qualified providers to mail the abortion pill to patients—at least for now—19 states prohibit medication abortion via telemedicine and mailing pills.

The Difference Between Pre-Roe and Post-Roe: The Abortion Pill

As states are adopting a record-breaking number of abortion restrictions, the Supreme Court has allowed a six-week abortion ban to go into effect in Texas, and the court has agreed to hear a case involving 15-week abortion ban in Mississippi, the abortion pill is more important today than ever before. Thanks to the abortion pill and innovative organizations committed to reproductive health and bodily self-determination, a reversal of Roe v. Wade would not send us back to the pre-Roe world of coat hangers and hospital wards full of deathly ill women.

A rally for reproductive rights in Ambler, Pa., in May 2019. (Governor Tom Wolf / Flickr)

Advocates are educating women about how to buy abortion pills online, receive them by mail, and use them at home, and evidence suggests that women are doing just that. Recently-published research reveals that Aid Access received 57,506 requests from people in the U.S. seeking abortion pills between 2018 and 2020, before the pandemic began. Online demand for abortion pills surged when the pandemic hit in early 2020, especially in states that closed abortion clinics such as Texas, where requests for abortion pills made to Aid Access increased by 94 percent.

The week after the Texas ban went into effect, traffic to the website of the abortion pill advocacy group Plan C spiked 2,357 percent — with 30 percent of those new visits coming from Texas. Online abortion clinic Aid Access, which prescribes abortion pills mailed from India for $150, also saw vastly increased traffic on their website—from less than 2,000 hits per day before the ban to about 10,000 on September 1 and then 30,000 on the September 2.

While the FDA still considers it “illegal” for overseas pharmacies to ship medications into the US, this is done all the time and the FDA has a policy of non-enforcement about importation of medicines for limited use (up to a 90 day supply). 

According to Elisa Wells, Plan C co-director:

“Aid Access is set up to comply with all the requirements in the places that they operate: Dr. Gomperts is licensed as a physician, so providing care legally. She writes a prescription for the patient, who then submits it to the pharmacy. The pharmacy is licensed to fill the prescription. And, because the doctor and pharmacy are both offshore, they feel protected from prosecution in the states that don’t allow telemedicine abortion.”

Self-managed abortion—when someone ends a pregnancy outside of a clinical setting, such as by buying abortion pills online—is not illegal in most states.  Only five states have explicit criminal prohibitions against individuals self-managing abortion: Arizona, Oklahoma, South Carolina, Delaware and Nevada. New York repealed their criminal prohibition on self-managed abortion in 2019. And while thirty-eight states have feticide laws that equate pregnancy termination with murder, most explicitly exclude pregnant women from criminal penalties. Last February the American Bar Association adopted a resolution against the criminalization of self-managed abortion and pregnancy loss.

But some overzealous prosecutors across the country have tried to criminally prosecute women for self-managing abortion. In response, the reproductive justice lawyers network  If/When/How has launched a nationwide Repro Legal Defense Fund (RLDF)—a first-of-its-kind resource to support women and others investigated, arrested or prosecuted for self-managed abortion. RLDF provides money for bail and legal representation. If/When/How also has a Repro Legal Helpline—a free, confidential helpline for callers to get legal information or advice about self-managed abortion. 

On September 17, Texas Governor Greg Abbott signed a bill banning the abortion pill after seven weeks of pregnancy and prohibiting mailing abortion pills in the state. But Abbott is spitting in the wind. No one will be able to stop women from obtaining abortion pills if they are determined to find them and use them. And strong evidence suggests they are.

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Carrie N. Baker, J.D., Ph.D., is the Sylvia Dlugasch Bauman professor of American Studies and the chair of the Program for the Study of Women and Gender at Smith College. She is a contributing editor at Ms. magazine. You can contact Dr. Baker at cbaker@msmagazine.com or follow her on Twitter @CarrieNBaker.