They Have 5 Days to Save Abortion Pill Access. Here’s the Plan
On the evening of Friday, April 7 — the Christian holiday Good Friday — religious-liberty-lawyer-turned-federal-judge Matthew Kacsmaryk issued an order suspending distribution of mifepristone, the most widely used abortion medication in America, nationwide within seven days.
By Monday morning, lawyers and reproductive rights advocates had launched themselves full force into a five-day scramble to preserve access to the abortion pill: A rushed, multi-pronged effort to stay — and, hopefully, overturn — Kacsmaryk’s ruling.
At the same time, they’re preparing for the potential fallout if their efforts aren’t successful: A period of “confusion and chaos” for both patients and doctors as they scramble to deal with supply-side shock to a widely-used medication, and for drug manufacturers as they confront a new reality in which decades-old approvals can be revoked on a single judge’s ill-informed whim.
“No court has ever overturned a long-standing drug approval, so we are in unprecedented territory here,” Jessica Ellsworth, lawyer for Danco Laboratories, manufacturer of the name-brand version mifepristone and a plaintiff in the lawsuit, said on a call with reporters.
Danco filed a request for a stay from the U.S. Court of Appeals for the Fifth Circuit — which has earned itself the dubious reputation as the “Trumpiest” court in the nation — on Monday.
The same day, lawyers from the Department of Justice also asked the Fifth Circuit to block Kacsmaryk’s order, which they called “extraordinary and unprecedented,” from going into effect. They asked the court to issue an order by Thursday at noon. Also on Monday, lawyers for the Biden administration requested a judge in Washington who issued a rival ruling — one that ordered the federal government to preserve access to mifepristone in 17 states — to “clarify” the government’s obligations in light of Kacmaryk’s order.
If the Fifth Circuit does not grant either Danco or the U.S. government’s request before the end of the week, Ellsworth said she expects they will seek a reversal of Kacsmaryk’s order from the Supreme Court.
“We are hopeful that we will not be in that situation of having to figure out what happens come the end of the day on Friday,” Ellsworth said. “If we get to a situation where everyone has denied stays and Judge Kacsmaryk’s injunction has taken effect, I think there will be some difficult questions that Danco needs to address, and some conversations that it will need to have with FDA around what happens next.”
One of thousands of urgent questions about what will happen if Kacsmaryk’s ruling remains in effect is whether or not Danco could apply for re-authorization for Mifeprex under a different application. That would entail assembling clinical data to support that application, data which the FDA typically takes 10 months to review, explained Kirsten Moore of the EMAA Project, an organization dedicated to expanding access to medication abortion. “We could, in reality, be facing a scenario where this medication is only available in a clinical trial setting — and not available to patients in the real world — for upwards of two, maybe three years, even if everybody wants to move fast,” Moore said. “It’s deeply upsetting to think about.”
Lawyers for abortion providers took pains on Monday to point out that Kacsmaryk’s order has not taken effect yet. “There is no change as to access to mifepristone until Friday, and there is a lot of legal activity that’s going to happen between today and Friday,” Jenny Ma, senior staff attorney at the Center for Reproductive Rights, told reporters. “We have not had even a single business day between when the decision came out and [now]. So there will be a lot of activity and more decisions that need to come down before then.” But, if Kacsmaryk’s ruling does go into effect, she acknowledged it will represent a “massive shock to the provision of care in the states where abortion access remains.”
A number of providers, including Hey Jane, Choix, and Just The Pill, have said they are prepared to offer abortions using misoprostol alone — the second pill in the two-pill medication abortion regimen — which doctors say is a safe and effective alternative for abortion and miscarriage management if mifepristone is not available.
In the meantime, some amount of mifepristone will remain in circulation, and Moore says providers with access to that medication would still be free to dispense it. “If the product is already on pharmacy shelves, typically, it can still be prescribed and dispensed,” Moore said. “It can’t be distributed by the manufacturer.”
“We don’t know exactly what will happen if the judge’s order takes effect,” said Jennifer Dalven, Director of the ACLU Reproductive Freedom Project. “What we do know is that there will be significant confusion and chaos, as providers try to provide the best care that they possibly can for their patients.”
If the ruling stands, chaos and confusion won’t be contained to abortion providers, hundreds of pharmaceutical executives warned in an open letter. Kacsmaryk’s opinion, they said, puts all other FDA-approved drugs at risk of similar lawsuits, introducing intolerable amounts of uncertainty to “the already inherently risky work of discovering and developing new medicines.”
For that reason, the executives said, “We call for the reversal of this decision to disregard science, and the appropriate restitution of the mandate for the safety and efficacy of medicines for all with the FDA.”