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The History of Mifepristone

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As we celebrate the 20th anniversary of mifepristone, we want to look back on the history of this medication and how it has expanded the options available for those seeking abortion care.

French researchers developed mifepristone (also known as RU-486) in the 1980s, to be taken along 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 for 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 U.S. Customs when bringing mifepristone into the country from Great Britain. 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 care use on September 28, 2000, twelve years after its original synthesis.

Today, medication abortion care is provided up to 10 or 11 weeks’ gestation in the United States. According to the Guttmacher Institute, medication abortion accounted for 39% of all abortion care in the U.S. in 2017, up from 20% in 2014. Since 2001, medication abortions have increased from 5% of all abortion care to 30% in 2017. The percentage of abortions that are medication abortions continue to increase today, with many people opting to take the pills in the comfort of their own homes. 

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. This classification prevents clinicians from prescribing mifepristone, but rather requires them to stock and dispense the pill directly to patients in-office. 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. 

With today’s ongoing global COVID-19 pandemic, this REMS rule requires 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 has allowed patients to obtain nearly all other REMS classified drugs by mail to avoid COVID-19 risks, but not mifepristone. It must be picked up at a clinic though it can be taken later at home. In the spring, 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 blocks 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 is 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 from COVID-19. 

The preliminary injunction now allows clinicians who stock mifepristone to mail the pill to their patients for medication abortion. However, barriers still remain. For states that already outlaw telemedicine for medication abortion, this injunction does not apply. It also does not apply to patients seeking early pregnancy loss care. And, the Trump administration continues to challenge the July ruling. On September 8, the ACLU went to the Supreme Court to continue fighting the Trump Administration and to ensure that mifepristone can remain more safely accessible during the COVID-19 pandemic.

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