By Dave Andrusko
On May 17, the 5th U.S. Court of Appeals will hear an appeal by the Biden administration asking the judges to maintain FDA approval of mifepristone after a 5th U.S. Court of Appeals panel placed limitations on mifepristone, the first of two drugs that make up the chemical abortion regimen.
At the request of the Justice Department and Danco, mifepristone’s manufacturer, the Supreme Court placed a hold (a stay) on the lower court rulings while the appeals process plays out. Justices Alito and Thomas dissented. While Thomas did not explain his reasons, Alito did in terse and pointed four-pages.
In the time leading up to and following the April 21 decision by the 5th Circuit, court actions have come fast and furious.
Ground zero for the fast-moving case was U.S. District Judge Matthew Kacsmaryk’s April 7 decision to suspend FDA approval of mifepristone. He accepted the argument of the Alliance for Hippocratic Medicine that the FDA had fast-tracked the approval of mifepristone through a process intended for the treatment of life-threatening illnesses
Judge Kacsmaryk issued a one week temporary stay to allow the government to appeal which it quickly did.
On April 12, the 5th Circuit Court of Appeals granted a partial stay, pending appeal. The 5th Circuit kept in place the portion of Judge Kacsmaryk’s order requiring the FDA to restore previous safeguards for chemical abortion drugs. The Biden administration appealed to the Supreme Court and on the following Friday the Supreme Court ordered a pause.
Meanwhile, 20 minutes after Judge Kacsmaryk handed down his decision, the Democratic attorneys general of 17 states and the District of Columbia won an injunction from U.S. District Judge Thomas Rice in Spokane. He issued a ruling “ordering the FDA to preserve access to mifepristone in those states, regardless of any conflicting court decisions,” barring the FDA from enforcing any additional restrictions on mifepristone in their states.
Yesterday, abortion facilities in Virginia, Montana, and Kansas filed a new lawsuit in U.S. District Court in Virginia, making essentially the same arguments as the 17 states and the District of Columbia did with Judge Rice.
“Plaintiffs cannot retool their practices overnight with no notice — healthcare has no on-off switch,” states the lawsuit, filed on behalf of the clinics by the Center for Reproductive Rights. “They and their patients require clarity around their continued provision of mifepristone.”
According to the Associated Press, “The group said it included abortion providers in Virginia, Montana and Kansas in the lawsuit because those states are not parties to either the Texas or Washington cases, but they have many lawmakers who are hostile to abortion access and ‘are caught in the middle of this maelstrom.’”
In recent years, the FDA has made mifepristone much easier to get and has removed critical safeguards for women.
For example, the FDA weakened the Risk Evaluation and Mitigation Strategy (REMS) requirements for the drug to allow it to be dispensed and even mailed by pharmacies. According to the 5th Circuit opinion, prior to the 2023 changes, the “FDA removed four of the original safety restrictions by
(1) increasing the maximum gestational age at which a woman can use the drug from 49 to 70 days; (2) reducing the number of required in-person office visits from three to one; (3) allowing non-doctors to prescribe and administer the chemical abortions drugs; and (4) eliminating the requirement for prescribers to report non-fatal adverse events from chemical abortion.”
But the FDA has repeatedly concluded that the remaining requirements — including prescriber certification and patient forms — are necessary,” the Associated Press reported [www.kctv5.com/2023/05/09/abortion-clinics-3-states-sue-protect-pill-access].
“In their lawsuit, the clinics argue that these restrictions ‘stigmatize and undermine access to medication abortion.’”