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The History of Mifepristone

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Updated April 18, 2023

Nearly three years ago, we celebrated the 20th anniversary of mifepristone and looked back on the history of this medication and how it expanded the options available for those seeking abortion care.

French researchers developed mifepristone (also known as RU-486) in the 1980s to be taken with misoprostol for medication abortion care. Despite the outcry of anti-abortion activists, it was approved for use in France in 1988. In the United States, however, it was a very different story, as the FDA banned the importation of mifepristone in 1989. The manufacturer of mifepristone, Roussel-Uclaf, also banned mifepristone distribution in the United States and refused to supply it to researchers investigating the drug’s other possible health benefits. 

The first challenge of this ban in the courts was by an American woman named Leona Benten, who was stopped by US Customs when bringing mifepristone into the country from the United Kingdom. Although Benten lost her case, it brought mifepristone into the national spotlight and galvanized the movement to overturn the FDA ban. When President Bill Clinton was elected in 1993, he ordered the Department of Health and Human Services to investigate mifepristone’s use for medication abortion. In 1995, Roussel-Uclaf agreed to give the Population Council the patent rights to mifepristone in the United States.

It wasn’t all downhill from there, however – although the FDA’s advisory branch recommended mifepristone for approval, legal and manufacturing troubles led to the medication being pushed to the side until 2000. Thanks to the work of activists and health professionals, mifepristone was finally approved for medication abortion on September 28, 2000, twelve years after its original synthesis.

Today in the US, medication abortion with mifepristone and misoprostol is provided in-clinic up to 11 weeks gestation. As of 2020, medication abortion accounted for 53% of all US abortions, up from 39% in 2017. Medication abortion has only been growing, especially as access to self-managed medication abortion information and support has increased due to the needs and preferences of communities most impacted by barriers to healthcare and abortion restrictions. 

Unfortunately, mifepristone remains inaccessible to many people. The US Food and Drug Administration (FDA) regulates mifepristone under a Risk Evaluation and Mitigation Strategy (REMS), which means it’s classified as a “dangerous drug” – despite its history of safe and effective use. There is an overwhelming body of scientific and medical evidence that shows mifepristone is safe and effective for virtually anyone in a variety of practice settings, including telehealth, in-clinic, and self-managed care. Until recently, the REMS rules on mifepristone required them to stock and dispense the pill directly to patients in-office, creating barriers to providing mifepristone in primary care settings. When mifepristone is inaccessible in primary care, patients are harmed. Their continuity of care is disrupted, emotional and financial consequences are exacerbated, they experience unnecessary and invasive procedures, and they must manage multiple appointments and delays in care. 

Early in the ongoing global COVID-19 pandemic, the REMS rule required patients to travel to the clinic to pick up mifepristone in-person, forcing those seeking abortion care to risk needless exposure to the virus. In fact, the FDA had allowed patients to obtain nearly all other REMS-classified drugs by mail to avoid COVID-19 risks, but not mifepristone. It had to be picked up at a clinic, though it can be taken later at home. In the spring of 2020, the American Civil Liberties Union (ACLU) filed a lawsuit on behalf of a coalition of medical experts and reproductive justice advocates to fight this rule. On July 13, 2020, a federal district court issued a preliminary injunction that blocked the FDA from enforcing its in-person pick-up requirement for medication abortion until at least 30 days after the end of the federal government’s declared public health emergency. This ruling was particularly important for low-income communities and those who are Black, Indigenous, and People of Color, as they make up the majority of those disproportionately impacted by COVID-19. 

The preliminary injunction became an official REMS modification in January 2023, allowing clinicians to not only mail mifepristone to their patients but also to prescribe the pill to certified pharmacies for patients to pick up or receive by mail. However, barriers still remain. For states that already outlaw telemedicine for medication abortion or ban abortion entirely, these rules do not apply. And, today, there are imminent threats to nationwide access to mifepristone through the Alliance for Hippocratic Medicine v. Food and Drug Administration case trying to force the FDA to remove mifepristone’s approval. This is entirely based on politics, not on medicine, science, or law. It is an extension of our nation’s history and ongoing present of reproductive coercion and control. This case should never have moved forward, yet as of April 21st 11:59 PM ET mifepristone is still available and accessible due to an administrative stay by the Supreme Court. 

This decision is part of an agenda to ban medication abortion – and all abortion – across the country. It attempts to prevent people from accessing abortion medication with threats of investigation, jail, and prosecution. If you are concerned about the abortion laws in your state, including self-managed abortion and the law, If/When/How’s Repro Legal Helpline provides free legal information and advice at reprolegalhelpline.org or 844-868-2812. And, if you need legal advice or representation for providing or helping others access abortion care, contact the Abortion Defense Network.

If you would like to receive updates on this issue and the Reproductive Health Access Project’s work to support primary care clinicians to protect and expand access to reproductive health care, including abortion, during this time, click here

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