A Texas judge is set to rule on the FDA’s approval of abortion pill mifepristone, with potential outcomes ranging from withdrawal to tighter restrictions. Anti-abortion groups expect an unfavorable decision for the FDA.
A Texas judge, Matthew Kacsmaryk, is expected to issue a ruling soon in a case challenging the Food and Drug Administration’s (FDA) approval of the abortion pill mifepristone. The Alliance for Hippocratic Medicine has asked Judge Kacsmaryk to nullify FDA medical approval of mifepristone which would effectively ban the drug across the US. If he rules against it, he could order tighter restrictions on access or completely halt sales altogether. Abortion rights groups and legal experts expect an unfavorable decision for the FDA as Judge Kacsmaryk was appointed by former President Donald Trump over concerns about his views on abortion and LGBTQ rights.
If an immediate withdrawal is ordered then there may be further litigation over whether such an order is legal; however if instead the formal process to withdraw begins then this can take months if not years before any final decisions are made meaning that clinics could still prescribe off-label drugs during this time frame.
In January 2021, the FDA permanently lifted a requirement that patients obtain mifepristone from certified health-care providers in person allowing telehealth appointments and delivery by mail but anti-abortion groups have argued that sending medication via mail violates federal law dating back more than 100 years ago called Comstock Act.