On May 1, the Fifth Circuit temporarily reinstated the pre-2023 in-person dispensing requirement for the chemical abortion pill mifepristone nationwide and blocked telehealth prescribing that allows residents in states with abortion bans to obtain the drugs in the mail. Danco Laboratories and GenBioPro immediately appealed the decision that would require anyone seeking chemical abortions to make an in-person visit to a clinic, at least during the duration of the trial. Supreme Court Justice Samuel Alito issued a one-week administrative stay on May 4. That stay is set to expire on May 11, while several special-interest groups, states, and the FDA submit amicus briefs to support or oppose the measure. Monday, the Supreme Court will decide whether to extend the stay or allow the Fifth Circuit’s temporary ruling to take effect.

The immediate decision will determine whether mifepristone is available through telehealth appointments during the trial, and the final decision will likely be made by the Fifth Circuit at the conclusion of the trial. However, the Supreme Court also has the option to grant certiorari and transfer the case from the Fifth Circuit to the Supreme Court for expedited review.

The issue involves a 2023 FDA Risk Evaluation and Mitigation Strategy (REMS) that removed the in-person dispensing requirement for mifepristone. This requirement was also removed during the COVID-19 pandemic, but wasn’t permanently removed until the FDA under President Joe Biden’s administration completed the REMS in 2023. The REMS was conducted by HHS Secretary Xavier Becerra at the direction of President Biden, who directed him to find ways to ensure it is “as widely available as possible” following the Supreme Court’s Dobbs ruling that overturned Roe v. Wade.

Louisiana is arguing that the FDA acted “arbitrarily and capriciously” in its review process. The Fifth Circuit determined that Louisiana was very likely to succeed in this case based on the evidence and that the state would be irreparably harmed if the stay isn’t granted. The Trump administration’s FDA announced in September 2025 that it was reviewing the mifepristone REMS decision, and it is “informed by the lack of adequate consideration underlying the prior REMS approvals, and by recent studies raising concerns about the safety of mifepristone as currently administered.”

The FDA’s statement is an admission that safety concerns weren’t considered in the review process. An amicus brief was submitted by 2,794 individuals who were injured by abortion, and a total of 4,855 legally admissible affidavits were also collected.

The brief includes testimony from a woman who was coerced by an abusive partner who was able to order the drug online via telehealth as a result of the Biden-era REMS. Another woman said she was coerced by her abusive partner and Planned Parenthood while they lied about the viability of her baby. Another woman said the doctor lied to her about the health impacts of the drug. She said she was bleeding heavily, thought she was dying, and was passing clots the size of baseballs. The woman felt shame and guilt after she saw her aborted baby in the toilet.  

In addition to the health impacts, post-traumatic stress disorder, and lack of informed consent testimonies, Louisiana is arguing that the FDA’s 2023 REMS violates the state’s sovereignty in protecting unborn life. The REMS effectively allows pro-choice states to export their policies to pro-life states, according to Louisiana’s argument.

163 reproductive health rights and justice organizations argue that “forcing patients to travel to a health center” will “endanger patient health and autonomy.” They say that mifepristone is critical for patients who need abortion and miscarriage care. The organizations also say that blocking the FDA 2023 REMS will cause economic hardship. The brief states that being “denied an abortion also increases women’s debt and negative public financial records, including bankruptcies and evictions.”

The manufacturers say that pharmaceutical companies have invested $850 billion over the last decade based on rules implemented by the FDA. They argue that overturning FDA rules would create market uncertainty and stifle innovation in medicine.

The case represents a contradiction between federal and state policy. The overturning of Roe v Wade allowed states to implement their own abortion restrictions, but the FDA REMS effectively took away state sovereignty to protect unborn lives by restricting abortion access. Louisiana argues that this causes irreparable harm through increased ER and Medicaid costs from the harms caused by out-of-state abortion pills. The state also discusses other harms, including coercion, lack of informed consent, and missed ectopic pregnancies.

Ectopic pregnancies are a contraindication for Mifepristone. The FDA and the label for the drug say that it is not effective and can be dangerous if somebody who has an ectopic pregnancy takes Mifepristone. The symptoms associated with a medical abortion can be the same as those of a ruptured ectopic pregnancy, including abdominal pain and uterine bleeding.

The drug label suggests providers should “assess the pregnancy by ultrasonographic scan if the duration of the pregnancy is uncertain or if ectopic pregnancy is suspected.” When a patient accesses chemical abortion pills via telehealth appointments, the provider is unable to conduct an ultrasonographic scan, which poses a greater risk that ectopic pregnancies could be missed. As Mifepristone is not effective for ectopic pregnancies and has the same side effects as a life-threatening ruptured ectopic pregnancy, there is an added risk from obtaining Mifepristone without an in-person evaluation.

More than one million abortions were performed in the United States in 2023, and 63% of those were medication abortions. That is a 10% increase from the number of medicated abortions that occurred in 2020. Since 2000, when Mifepristone was first authorized by the FDA, there have been 36 deaths associated with Mifepristone. That includes two ectopic pregnancies.

Clinics are prepared to pivot their protocol if Mifepristone is restricted, to still allow access to medical abortions. Misoprostol is an alternative medication that is often used alongside Mifepristone in medical abortions. Clinics are prepared to provide Misoprostol-only abortions if Mifepristone access is restricted by the court.

Steven Middendorp

Steven Middendorp is an investigative journalist, musician, and teacher. He has been a freelance writer and journalist for over 20 years. More recently, he has focused on issues dealing with corruption and negligence in the judicial system. He is a homesteading hobby farmer who encourages people to grow their own food, eat locally, and care for the land that provides sustenance to the community.

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