Access to Abortion Pill on the Precipice

FOR A BRIEF moment in time last April, the U.S. Food and Drug Administration’s (FDA) approval of the commonly used abortion medication, Mifepristone, was curtailed. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. Department of Justice (DOJ) asked the Fifth Circuit to grant an emergency or administrative stay of that decision. On review, the Fifth Circuit held that Mifepristone could only be prescribed in the first seven weeks of pregnancy, under a physician’s supervision, and the drug cannot be sent by mail, temporarily suspending more recent modifications to the FDA’s approval. The Fifth Circuit’s decision was issued in the backdrop of another decision out of the Eastern District of Washington enjoining the FDA from altering the status quo as it relates to the availability of Mifepristone in 17 states and Washington, DC. Due to the “regulatory chaos” that ensued since the issuance of the Fifth Circuit order, Danco Laboratories, LLC (Danco), distributor of the drug, Mifepristone, sought emergency relief from the U.S. Supreme Court to either stay the Texas District Court’s preliminary injunction in full pending appeal or grant certiorari in the case. The DOJ followed suit immediately thereafter, filing its own emergency request with the U.S. Supreme Court to restore access to the drug nationwide. Hours before the restrictions were set to go into effect, Supreme Court Justice Samuel Alito placed a five-day administrative stay on the Fifth Circuit’s order, and shortly thereafter, the Supreme Court granted the stay in full, preserving nationwide access to Mifepristone pending appeal. Currently, the fate of Mifepristone lies with the Fifth Circuit as it considers whether to curtail the FDA’s approval of the drug. It is anticipated that, regardless of how the Fifth Circuit rules, the decision will be appealed to the U.S. Supreme Court. Until such time, Mifepristone remains on the market without court-imposed restrictions. This article provides an in-depth analysis of the implications of the Texas case, including the availability and use of the Mifepristone drug going forward, and the potential impact to the FDA’s broader authority, if the Texas plaintiffs ultimately prevail. Read more here.