The Supreme Court extended its stay on lower court rulings on mifepristone until Friday just before midnight, meaning that the drug will remain accessible and available at least until then.
The order, written by Justice Samuel Alito, came “upon further consideration of the application of counsel for the applicants, the response and the reply.”
The Court’s initial stay would have expired just before midnight Wednesday, bringing restrictions to the drug into action.
While the Supreme Court mulls the case, action hasn’t stopped in the lower courts. In a new, separate lawsuit, the maker of generic mifepristone sued the FDA Wednesday to not revoke its approval or take it off the market without going through the mandated processes, including the Heath and Human Services Secretary declaring that the drug is an imminent risk. The company, GenBioPro, argues that court rulings don’t trump the required steps the agency has to take to remove its approval.
See here for the previous update. I didn’t see any speculation about What It All Means in the news coverage I read, but we do still have Twitter for some things:
At most, this development *maybe* tilts the odds *marginally* more in favor of a stay pending appeal (else why extend the administrative stay).
But I don’t think extending the administrative stay changes the bottom-line probabilities in any material respect.
— Steve Vladeck (@steve_vladeck) 2:32 PM – 19 April 2023
Yes, it’s very unusual for a Justice to extend an administrative stay—but Alito is the *only* Justice who regularly puts deadlines on them in the first place. For most of the Justices, administrative stays are indefinite, so never need to be “extended.”
Uniformity would be nice.
— Steve Vladeck (@steve_vladeck) 3:39 PM – 19 April 2023
Pessimistic take: The court denied a stay and a liberal is writing a dissent.
Optimistic take: The court granted a stay and a conservative is writing a dissent.
Panglossian take: The court is writing an opinion reversing the 5th Circuit and directing it to toss the case.
— Mark Joseph Stern (@mjs_DC) 2:19 PM – 19 April 2023
Make of that what you will. In the meantime, there’s that other case that was just filed.
GenBioPro, the maker of generic mifepristone, made a bid to establish a backstop Wednesday, should the Supreme Court decide to restrict one of its primary products.
The company sued the Food and Drug Administration (FDA) in federal court in Maryland, seeking assurances that the agency wouldn’t revoke its approval or try to remove it from the market.
This lawsuit, while separate, flows from the chain that started with Judge Matthew Kacsmaryk in Texas. That case is currently at the Supreme Court, which is due to hand down a ruling in the case, but which extended its stay on the lower court opinions until Friday just before midnight. As it stands, the Fifth Circuit Court of Appeals ruled to reimpose restrictions on the drug that the FDA had lifted in recent years — and to nix the agency’s 2019 approval of generic mifepristone altogether.
While that case unspooled, GenBioPro, per its Wednesday filing, has been deluging the FDA with letters in an attempt to make sure that its product won’t be yanked off the market. After getting unsatisfactory responses, the company turned to the government’s filings in the case, where it warned that “[t]he generic version of the drug would cease to be approved altogether.”
Now, the company is arguing that the FDA is prepared to illegally revoke its approval without going through the proper steps: A finding by the Heath and Human Services Secretary that the drug is an “imminent hazard” and an expedited hearing once the drug is suspended. These unprecedented court orders, GenBioPro argues, don’t trump the congressionally-delegated processes the FDA must follow to remove its product from the market.
“With the specter of criminal prosecution looming, GenBioPro may be obligated to undertake recalls, cancel contracted manufacturing and hold or destroy perishable inventory,” the company’s lawyers write. “And because of the FDA Decision and the enforcement risk and uncertainty it has created, GenBioPro is suffering irreparable financial and reputational harm, severely threatening its core business model and commercial viability.”
GenBioPro is asking that the FDA be forbidden from suspending or altering its approval, and from using its enforcement power to take it off the market, unless the agency goes through the established process to revoke the drug’s approval. It makes its arguments under a constellation of laws, including the Fifth Amendment, Administrative Procedure Act and All Writs Act.
This lawsuit is the legal equivalent of breaking glass in case of emergency. GenBioPro has its finger in the wind — and is clearly uncomfortable depending on the Supreme Court to maintain its drug’s accessibility.