Twelve US states, led by Washington and Oregon, have filed a lawsuit against the US government over access to the abortion pill mifepristone. The states allege that the US Food and Drug Administration (FDA) has placed “particularly burdensome” restrictions on the pill, making it harder for patients to access the medication when they need it. The lawsuit was filed in the US District Court in the Eastern District of Washington and includes Washington, Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island and Vermont. All twelve states are Democrat-led.
The availability of pills to end early pregnancy has become a pivotal battleground for reproductive rights in the US, particularly following the Supreme Court decision last June to overturn Roe v Wade. The states involved in the lawsuit argued that “the availability of medication abortion has never been more important”, as other states have moved to criminalise and civilly penalise abortion.
Mifepristone was developed in 1980 and approved by the FDA in 2000 as the first part of a two-drug regimen to end pregnancies under 10 weeks. It is taken in combination with misoprostol, another pill. According to the Guttmacher Institute, an estimated 54 percent of abortions in the US employ abortion pills, with that number expected to rise as telehealth increases the frequency of remote medical consultations.
However, the FDA has categorised mifepristone under its Risk Evaluation and Mitigation Strategies (REMS) programme, a drug safety framework for “certain medications with serious safety concerns”. The twelve states are pushing for the US District Court to remove mifepristone from the programme, arguing that it has been used more than five million times “with very low rates of complications” and that it is being wrongly placed in a “very limited class of dangerous drugs”.
In response to the lawsuit, the FDA agreed to modify mifepristone’s REMS programme, effective on January 3, “to reduce burden on the health care delivery system”. However, under the updated guidelines, the pill must still be prescribed by a healthcare provider and dispensed under the supervision of a certified prescriber, with documentation signed and reviewed along the way. The twelve states argue that this “burdensome documentation” is making “telehealth less accessible and creating a paper trail that puts both patients and providers in danger of violence, harassment and threats of liability”.
The FDA has warned that any kind of abortion, miscarriage or childbirth carries the risk of “serious and potentially life-threatening bleeding, infections or other problems”. But it has also underscored that those risks are rare and that there is no information that mifepristone has caused any deaths.
Thursday’s lawsuit follows other legal challenges to abortion pill restrictions in North Carolina and West Virginia, filed in January. This month, a Texas judge appointed under former Republican President Donald Trump is expected to rule in a case that could overturn the FDA’s approval of mifepristone. As of January, thirteen states have bans on abortion at all stages of pregnancy and nineteen have laws controlling the prescription and use of abortion pills. By contrast, some of the states involved in Thursday’s lawsuit have taken steps to protect abortion access in their constitutions.