While the U.S. Supreme Court considers the future of access to the abortion medication, mifepristone, another lawsuit against the FDA that would expand access to the medication is on hold.

Last year there were two separate cases against the FDA – one to restrict access to mifepristone and one to expand it. The U.S. Supreme Court heard arguments in Alliance for Hippocratic Medicine v. FDA, which is the case that could restrict access, last month and will issue a decision later this year. The suit trying to expand access, Washington et al v. FDA, alleges that the FDA is acting improperly and discriminatorily by maintaining some regulations around the drug that are unnecessary. 

In the Washington et al v. FDA case, a Washington state federal judge placed a preliminary injunction but has yet to rule. The preliminary injunction, in effect, shielded Washington and the 17 other jurisdictions, including New Mexico, from the separate case, the Alliance for Hippocratic Medicine v. FDA. In that case, a Texas district judge made the initial ruling against the FDA in the case brought by the Alliance trying to restrict access last spring. The FDA appealed the Texas district judge’s decision, which led the case going to the Supreme Court.

New Mexico Attorney General Raúl Torrez told NM Political Report that if the Supreme Court rules in favor of the Alliance in the Texas case, that could impact the case Washington and the 17 additional jurisdictions’ have made to expand access.

But if the majority of the Supreme Court justices rule against the Alliance and do not delve into the FDA’s approval process in the case before it, that could leave room for the Washington district court to consider expanding access, Torrez said.

Washington state and the 17 jurisdictions note that since the FDA gave its approval for mifepristone to be available as one step in a two-step abortion medication regimen in 2000, it has been used approximately 5.6 million times in the U.S. The drug first began to be used in France in the late 1980s for abortion, the complaint states.

In its review of the drug’s efficacy and safety in 2016, the FDA found that serious adverse events, including death, hospitalization, serious infection, bleeding requiring a transfusion or ectopic pregnancy are at rates far below 1 percent and the medication is, therefore, safe.

The Washington state complaint states that mifepristone is safer than Tylenol and Viagra, both of which are available without a prescription.

But although the FDA removed some restrictions in 2016, and then removed more during the pandemic, the agency still requires that a medical professional or a pharmacist that dispenses the drug must obtain certification in advance to provide the medication.

This can lead to fear, especially since some states have banned abortion, including medication abortion. The complaint states that one abortion clinic in Washington was subject to a hacking attempt to access its data. Requiring the certification can put both patient and provider at risk, the complaint states.

The complaint also says that there are 20,000 drugs available that have received FDA approval. Torrez said the most dangerous, such as fentanyl, require special restrictions in the same way mifepristone does.

“Mifepristone, in contrast, doesn’t have the same adverse safety issues and unique characteristics the science would justify having added restrictions. It’s our view this is not the current best science because of these extra barriers to access that should be taken down. If the [Washington state district] court orders the FDA to remove the REMS [federal restrictions] from the drug using current best science, that is justified,” Torrez said.

Since the FDA removed some of its restrictions in 2016, which increased its accessibility, the use of abortion medication has increased to more than half of all abortions are through abortion medication. 

Amanda Stevenson, assistant professor of Sociology at the University of Colorado-Boulder, studies the impacts of reproductive health policies. She told NM Political Report that if the Supreme Court rules even very narrowly to further restrict access to mifepristone, in the Alliance case against the FDA, it would expose some individuals to the risk of pregnancy, which “are not insubstantial.”

She said that many of those who need an abortion are “at the greatest risk for pregnancy morbidity and mortality.”

Individuals of color have greater barriers to both positive health outcomes, have higher rates of maternal mortality and morbidity and face greater barriers to abortion access.

Stevenson said that studies have shown that those who are denied an abortion have worse outcomes in health, higher rates of poverty and face greater adverse economic outcomes like medical debt. She said they are also more likely to remain in abusive relationships and are more likely to have mental health problems.

“When a person is prevented from obtaining a wanted abortion, they are forcibly exposed to the risk of staying pregnant which is greater than the risk for abortion,” she said.

Torrez said the New Mexico Department of Justice [formerly known as the Attorney General’s Office] joined the Washington state lawsuit against the FDA because mifepristone “is a safe and effective medication.”

“It’s been on the market [in the U.S.] for 24 years. It shouldn’t be restricted like drugs like fentanyl is classified,” he said.