UPDATE (April 19, 2023, 3:32 p.m. ET): The Supreme Court on Wednesday issued an order keeping abortion pill restrictions from taking effect through at least Friday.
The legal fight over access to a commonly used abortion pill is now in the hands of the Supreme Court that overturned Roe v. Wade last year. And the federal government and drug manufacturers are sounding the alarm on the devastating consequences of potentially allowing restrictions on the drug to take effect.
Supreme Court Justice Samuel Alito issued an order Friday temporarily blocking lower courts’ rulings that would restrict access to mifepristone, an abortion pill approved by the Food and Drug Administration in 2000. (Don’t read too much into the conservative justice’s role here; he’s assigned to handle emergency litigation from the relevant appeals court in this case.)
A more definitive ruling could come Wednesday from the GOP-majority Supreme Court — Alito’s order expires at the end of Wednesday — though whatever the justices do in this emergency litigation may not be the last word.
Seeking to keep the restrictions paused while litigation continues, the Justice Department warned in a legal filing Tuesday that allowing the restrictions to go forward “would scramble the regulatory regime governing” mifepristone, which has been used by more than 5 million women since the FDA’s approval decades ago.
The Justice Department further argued in its Tuesday filing that, without a stay: Every extant package of [brand name mifepristone made by Danco Laboratories] Mifeprex would instantly become misbranded and could not be lawfully introduced into interstate commerce. The generic version of the drug, which accounts for most of the market, would cease to be approved altogether. And before Danco could resume introduction of the drug into interstate commerce, FDA would be forced to change the drug’s labeling and other regulatory materials — including by reinstating an obsolete dosing regimen that provides for women to take more of the drug than necessary.
In its own filing Tuesday, Danco called Donald Trump-appointed Judge Matthew Kacsmaryk’s April 7 order, which kicked off this mess, a “first-in-a-century judicial second-guessing of FDA’s scientific judgment” that caused “immediate chaos and nationwide confusion.” And though a 5th Circuit Court of Appeals panel led by two Trump-appointed judges arguably narrowed Kacsmaryk’s order, the company said the panel’s action “doubled down on the judicial second-guessing of FDA” and was “no more narrow in effect”: It equally precludes lawful distribution of Mifeprex until Danco can obtain FDA approval to implement a now-obsolete dosing regimen involving higher doses of mifepristone and unwinding seven years of FDA approvals—a process that would take months even if FDA were not separately enjoined by another court from taking any action related to mifepristone’s conditions on distribution.
Noting the absurdity of the argument that the anti-abortion doctors have standing to bring their suit — which the lower courts endorsed — Danco wrote, “If this litigation involved any other drug, there would be no debate that a group of doctors who [1] do not prescribe it and [2] rely on a statistical possibility of encountering a patient in need of follow up care would be found to lack standing.” Adding to the chaos and uncertainty is a conflicting order to Kacsmaryk’s issued on the same day as his, from Barack Obama-appointed Judge Thomas Rice in Washington. Rice’s ruling blocked the FDA from altering mifepristone access in the jurisdictions from that separate case, which include 17 states and the District of Columbia. Kacsmaryk’s order purported to apply nationwide.
Jordan Rubin is the Deadline: Legal Blog writer. He was a prosecutor for the New York County District Attorney’s Office in Manhattan and is the author of “Bizarro," a book about the secret war on synthetic drugs. Before he joined MS NOW, he was a legal reporter for Bloomberg Law.
Latest Post
Recommended
