Chemical Abortions And Telehealth In 5th Circuit’s Hands

In 2000, the FDA approved the drug mifepristone, which is an abortion pill that is responsible for a majority of medical abortions conducted across the United States. The drug was initially to be used for pregnancies in their seventh week, though in 2016 the FDA granted access to pregnancies in their tenth week. Furthermore, the FDA allowed the drug to be prescribed via telehealth appointments.[1]These developments caught the eye of The Alliance For Hippocratic Medicine (AFHM). They sued the FDA and took their concerns before Judge Matthew J Kacsmaryk of the United States District Court for the Northern District of Texas. Kacsmaryk declared that the drug was unsafe and revoked the FDAs initial approval of the drug in 2000 and challenged the updates made to the drug's usage in 2016.[2]The FDA appealed the decision to the 5th Circuit Court of Appeals, which only put a hold on some parts of Kascmaryk’s order until the case was resolved. The FDA then advanced their claims again, requesting the Supreme Court to place a hold on the order until the dispute could be totally resolved. The Supreme Court agreed, and the order was frozen on April 21st, 2023.[3]When the case was finally heard by the 5th Circuit, the court contended that the AFHM’s claims were brought too late to revoke the drugs approval in 2000, though it did agree with Kascmaryk’s decision that the 2016 and 2021 changes to the drugs accessibility should be held.[4] Considering the conservative leaning of the Robert’s Court, they are expected to announce their consideration of the case this fall.Although it is unlikely that mifepristone will be totally removed from the market, the reduction of telehealth services could be deeply concerning for people living in rural areas. The CDC claims that telehealth is useful because it, “can help reduce barriers to care for people who live far away from healthcare services and specialists, who have time or access restrictions, or who have transportation or mobility issues.”[5] While the CDC discusses telehealth in the context of chronic disease prevention, the rollback of telehealth services for abortion medication may provide the necessary precedent for a general rollback of pandemic-era medical accessibility legislation. Even more concerning, though, is Judge Kascmaryk’s justification for his original ruling. He stated that, “Considering the intense psychological trauma and post-traumatic stress women often experience from chemical abortion, this failure should not be overlooked or understated.”[6] He is referencing the claim that the FDA did not consider the psychological impacts of mifepristone before declaring it safe. While it is certainly plausible that psychological trauma can result from chemical abortions, or any abortion procedures for that matter, that possibility being used as a justification for restricting abortion access can act as a catch-all legal reason for restricting all abortion methods.To avoid this possibility, it would be prudent for the FDA and Biden Administration to reconsider what constitutes psychological trauma as it pertains to FDA drug evaluations. While abortion access is a politically changed topic, even Judge Kascmaryk states that “FDA might have lawfully approved mifepristone under Subpart H for cases where a pregnant woman’s life or health is in danger.”[7] To allow for women to seek abortions in cases such as these, it is imperative that the FDA create more robust methods for ensuring that challenges cannot be brought against abortion medications on psychological grounds without strong evidence.