Fifth Circuit Decision Directs FDA to Restrict Mifepristone Access

The Fifth Circuit Court of Appeals has issued a ruling in State of Louisiana et al. v. Food and Drug Administration (FDA) et al, ordering the FDA to temporarily reimpose medically unnecessary in-person dispensing requirements on mifepristone—and upending abortion access nationwide. An emergency appeal to the US Supreme Court will likely follow swiftly, and we will share relevant updates as they occur.

This litigation was initiated by plaintiffs seeking to reimpose in-person dispensing and other restrictions that the FDA permanently removed from the risk evaluation and mitigation strategy (REMS) for mifepristone in 2023, in line with robust research showing they were not medically necessary. A federal district court paused the case in early April to give the FDA time to complete a safety review of mifepristone that it had initiated at the urging of anti-abortion groups, despite overwhelming evidence that the drug is safe and effective. After the district court ruling, plaintiffs quickly appealed to the Fifth Circuit to reimpose the in-person dispensing requirement. 

The end goal of this legal attack is to eliminate telehealth prescribing, pharmacy dispensing, and mailing of mifepristone nationwide, including in states that have not enacted total abortion bans. 

Below, we’re sharing a statement from our vice president for public policy, along with key data and resources: 

Statement from Kelly Baden, Vice President for Public Policy at the Guttmacher Institute:  

“The decision is a stunning and deeply alarming development.  Reimposing medically unnecessary in-person dispensing requirements for mifepristone will send shockwaves of chaos and confusion across the country and dramatically upend patients’ ability to obtain abortion care.

“While this is not the final word on the case, this decision represents the most sweeping threat to abortion since the overturning of Roe v. Wade. If allowed to stand, it would severely restrict access to mifepristone in every state, including those where abortion is broadly legal and where voters have acted to protect abortion rights.

“This move runs counter to decades of scientific evidence from the United States and around the world that overwhelmingly affirms that mifepristone is safe and effective whether provided in person or via telehealth. Data from the Guttmacher Institute show that medication abortion accounts for roughly two out of every three abortions nationwide, while the Society of Family Planning finds that one in four abortions are provided via telehealth.

“Patients should not be forced to navigate ever-changing restrictions that disregard evidence and established standards of care. But abortion providers and support networks have shown amazing resilience and tenacity since the Dobbs decision—and they will continue to do what they can do to ensure that everyone, regardless of where they live, can access the abortion care they need.” 

Here’s what the data show about medication abortion use and how reinstating in-person dispensing requirements could upend the abortion care landscape: