AG Curtis Hill Appeals Federal Court Ruling That Suspended FDA Abortion Pill Requirements

Attorney General Curtis Hill this week appealed a district court’s preliminary injunction that temporarily prevents the United States Food and Drug Administration (FDA) from enforcing certain requirements for mifepristone, a drug used in medication abortions.

The FDA requires that mifepristone be dispensed only in clinics, medical offices or hospitals. The American College of Obstetricians and Gynecologists (ACOG) sued the FDA in May, arguing that, during the COVID-19 pandemic, the in-person dispensing requirement violates both the due process and equal protection requirements of the U.S. Constitution’s Fifth Amendment. On behalf of Indiana and nine other states, Attorney General Hill sought to intervene in the case to aid in defense of the FDA requirement on the grounds that any ruling adverse to FDA could undermine similar state laws governing mifepristone.

A judge for the U.S. District Court for the District of Maryland denied the States’ request to intervene but granted ACOG’s request to enjoin the in-person dispensing requirement. Attorney General Hill has appealed both the intervention order and the preliminary injunction, arguing in a brief filed Monday that the district court wrongly ignored the States’ legitimate interests in the case, ignored evidence submitted by the States in support of the FDA requirement, and applied the wrong legal standard to ACOG’s claims. 

The current risk evaluation and mitigation strategy (REMS) for mifepristone requires that the drug only be dispensed in certain health care settings and by only health care providers who are certified in the drug’s REMS program. Additionally, it requires that patients be informed about the risk of serious complications associated with mifepristone. Without these requirements, women may encounter an increased risk of dangerous complications from the drug, including hemorrhaging, infection and other injuries.

“These reasonable requirements, which have been in place for many years, are paramount in ensuring that women who seek medication abortions receive proper medical attention and are empowered with knowledge,” Attorney General Hill said. “Requiring that abortion drugs be dispensed only in person also helps deter coerced abortions and human trafficking,” he added.

“While the COVID-19 pandemic burdens many facets of life, it does not target abortion or reduce the need for proper safety protocols concerning abortion-inducing drugs,” Hill observed. “I will continue my efforts to keep Hoosier women safe, including those who may be coerced into abortion and those who are victims of human trafficking.”

Indiana separately requires abortion providers to follow the FDA guidelines, including the requirement that providers dispense mifepristone only in person. The district court expressly concluded that Indiana’s enforcement of that law is unaffected by the injunction against FDA.