How a Challenge to Mifepristone Could Disrupt Drug Regulation at Large

Sarah Wetter, JD, MPH, is a senior associate with the O’Neill Institute.”/>

Since the FDA approved mifepristone over 25 years ago, the drug has been part of an extremely safe and effective regimen for terminating a pregnancy, with the risk of serious complications less than 1%. Nearly two-thirds of all people seeking abortion choose medication over the surgical procedure. Since 2021, abortion medication has been accessible through telemedicine and the most recent data show that about 28% of all abortions are through telemedicine.

Despite mifepristone’s proven safety, efficacy, and popularity, access to the drug is under attack. Most recently, these attacks came to a critical point when the Fifth Circuit sided with Louisiana and ruled to “stay” (i.e. invalidate) the FDA’s 2023 regulation changes that permanently removed in-person dispensing requirements on mifepristone. On May 14, the Supreme Court preserved access to mifepristone as Louisiana’s challenge to the drug’s regulation works its way through the courts.

Although the Court’s action staved off potential chaos and uncertainty for now, threats to mifepristone and FDA’s regulatory authority are likely to continue.

How Did We Get Here?

Access to mifepristone, approved by FDA in 2000, is regulated by a “Risk Evaluation and Management Strategy” (REMS). Under federal law, the REMS must align with specific risks imposed by the drug, and in mifepristone’s case, the REMS has been adjusted over time largely to increase access.

Beginning in 2021, the FDA allowed mifepristone to be dispensed through pharmacies or the mail. These changes were formally adopted in 2023, when the FDA revised the REMS to permanently eliminate a prior in-person dispensing requirement. A recent JAMA analysis of internal documents from 2011-2023 concluded that FDA’s regulation of the drug has been grounded in scientific evidence.

Litigation over mifepristone access dates back to at least 2017. More recently, in 2024, the Supreme Court found that a group of anti-abortion physicians and medical associations lacked standing to bring their challenge to mifepristone’s regulation. However, the challenge did not end there, with several states, including Louisiana, continuing to challenge FDA’s regulation of mifepristone.

The Louisiana Challenge

The attorney general of Louisiana, alongside a Louisianan woman, allege that access to mifepristone via telehealth and mail harms the state’s residents, increases Medicaid expenditures, and prevents the state from enforcing its multiple abortion bans. Shortly before the lawsuit was filed, the FDA announced that it would conduct a review of mifepristone’s REMS due to “concerns about the safety of mifepristone as currently administered.” Nevertheless, Louisiana asked the court to invalidate the 2023 REMS — which would force women to pick up the medication in person — as the litigation proceeded. In response, the Trump administration did not defend the 2023 REMS but instead argued that the plaintiffs lacked standing to bring the case and asked the court to pause the litigation as FDA conducted its review. Danco and GenBioPro, manufacturers of abortion medication, intervened to defend the FDA’s regulation.

How Courts Have Ruled

On April 7, 2026, a federal district court granted the Trump administration’s request and denied Louisiana’s request to invalidate the 2023 REMS while the litigation proceeds. Louisiana promptly appealed the decision and asked for an emergency order to forbid telemedicine and mail access while the appeal is pending. On May 1, the Fifth Circuit Court of Appeals ruled in Louisiana’s favor, staying the 2023 changes with immediate, nationwide effect. The decision sowed mass confusion on its legal and practical effect, as the FDA’s pre-2023 rules would not “simply snap back” because the current rule was blocked by a court, the drug manufacturers and other experts explained.

In turn, Danco and GenBioPro asked the Supreme Court to provide emergency relief, highlighting that the Fifth Circuit’s decision was unprecedented in blocking “a several years’ old drug approval.” Notably, the Trump administration did not join in the drug companies’ request for Supreme Court intervention.

The Supreme Court initially blocked the Fifth Circuit’s ruling for 2 weeks. Then this week, the High Court ruled to block the Fifth Circuit’s order as the case works its way through the courts, preserving broader access to mifepristone in the meantime.

The Implications

While telemedicine and pharmacy access to mifepristone is preserved for now, the issue will continue to be litigated in the Fifth Circuit, and could land back before the Supreme Court. Depending on how the courts ultimately rule, access to mifepristone could eventually become severely restricted. Most clearly, the in-person dispensing requirement could be reinstated. This would mean that patients seeking medication abortion could only obtain mifepristone directly from their provider in-clinic, rather than at their local pharmacy or through the mail via telemedicine.

These impacts should not be understated. For many, the option to use telemedicine promotes autonomy and privacy, especially in cases of intimate partner violence. For others, it enables them to overcome access barriers, whether due to long travel distances to abortion clinics, lack of transportation, lack of childcare, or inability to take time off work. For these reasons, reinstating the in-person dispensing requirement is a matter of equity, with the greatest effects on lower-income, rural, minority, and other underserved populations. Ultimately, restricting access to mifepristone threatens women’s health and safety. It will lead to delayed and often riskier care, not only for those seeking abortion, but also for those using mifepristone for miscarriage management.

If a court ultimately overturns the FDA’s 2023 changes to mifepristone’s regulation, that would impact other drugs, too. An amicus brief from pharmaceutical company trade group the Pharmaceutical Research and Manufacturers of America (PhRMA), conveys how detrimental this would be. Collectively, PhRMA’s members have invested over $850 billion in researching new treatments in the last decade alone. In doing so, they rely on the “comprehensive, science-driven process for evaluating drug safety and effectiveness” established by Congress.

The drug companies make clear that “[a]llowing states to leapfrog over the [FDA’s] process to invoke the judicial process would inject instability into that framework…undermining the settled expectations that enable the development and distribution of medicines.” The drug companies also emphasize the importance of the flexibilities that Congress intentionally built into the REMS program that enable FDA to respond to emerging information and facilitate “access based on evolving evidence.”

Further, the FDA already maintains an established process for states and others to raise safety concerns on drugs. Allowing states to alternatively seek judicial intervention to thwart FDA decisions could upend this process and open the doors to challenging any drug decision via litigation.

All of this will affect patients’ access to drugs, and the trust in knowing that the regulation of those drugs is based on rigorous safety analysis. If courts and partisan politics are given an outsized role in regulatory determinations on drugs, the consequences will be severe.