On January 3, 2023, the Food and Drug Administration (FDA) modified the rules that restrict access to the abortion medication mifepristone; this allows pharmacies to dispense the drug directly to patients who have a prescription. The change is a critical step toward broadening the availability of mifepristone and increasing abortion access across the United States.
Although the FDA approved mifepristone in 2000, the FDA’s placement of the medication on its Risk Evaluation and Mitigation Strategies (REMS) list has historically hampered its accessibility. Among the restrictions placed on mifepristone was a requirement that certified medical professionals could only dispense the drug in hospitals, medical offices, or clinics. In 2021, due to the COVID-19 pandemic, the FDA temporarily lifted this in-person requirement and began allowing patients to access care via telemedicine and receive their prescriptions through the mail. In December 2021, the FDA announced that it would permanently waive the in-person dispensing requirement, a process that culminated in the January 2023 rule change.
Under the newly modified REMS program, the FDA has expanded access to mifepristone by making the pills available in retail brick-and-mortar pharmacies. Pharmacies interested in dispensing mifepristone must complete an FDA certification process to participate. Large chain pharmacies such as Walgreens and CVS have released statements expressing their intent to administer the product in their stores.
As we mark the 50th anniversary of Roe v. Wade and the first Roe anniversary since the Supreme Court overturned the decision, the conversation of reproductive rights and access is at the forefront of social movements. Abortion access is a fundamental element of reproductive justice and care. According to IWPR research, access to the full range of reproductive health services, including abortion, is often linked to other indicators of well-being and progress for women, such as employment and earnings, political participation, and educational attainment/opportunities. States like Missouri, Idaho, Nebraska, Arkansas, and South Dakota are ranked the worst nationally regarding reproductive access. Within these states, the economic loss of abortion restrictions is approximately $8.5 billion, ranging from $5.3 billion in Missouri to $362.9 million in South Dakota. In the state of Texas, home to one of the most restrictive abortion bans in the country, the economic loss to women and the state economy is $14.5 billion annually.
However, severe challenges to mifepristone access persist. Anti-abortion activists have taken the FDA to court over the approval of mifepristone, seeking to have the drug wholly removed from the market. In the wake of the FDA announcement, more than 20 state attorney generals have threatened to enforce state laws to restrict mifepristone access. In the face of these attacks, the Biden Administration has stood firm, issuing a Presidential Memorandum on January 22, 2023, calling on federal agencies to explore additional steps to protect access to medication abortion further.
Critically, the Biden Administration has also made it clear that the U.S. Postal Service can deliver mifepristone, even in states where abortion is illegal. The Department of Justice’s Office of Legal Council has issued an opinion that, according to Section 1461 of title 18 of the U.S. Code, there is no prohibition for drugs that have multiple uses, including causing an abortion, to be mailed. Mifepristone through mail provides a vital option for people in places where abortion access is limited and, potentially, even in areas where states have passed restrictions and bans.
Since the Supreme Court ruling of Dobbs v. Jackson Women’s Health Organization in 2022, abortion access has been severely limited, if not outright banned, in many states. Given the increased accessibility of mifepristone, numerous state-level actions have taken place to deny access to medication abortion. Last week, lawsuits were filed in West Virginia and North Carolina, challenging state laws limiting access to medication abortion.
In light of ongoing attacks on abortion access, the Biden administration must continue to pursue every avenue available to increase access to mifepristone. Expansion of access to medication abortion cannot solve the crisis created by the Dobbs decision. Still, the continued commitment by the Biden Administration to expand access to mifepristone has the potential to help millions of women access abortion care – and to counteract regressive state legislation.