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.
It’s also a lawsuit that matches the times. Kacsmaryk and the Fifth Circuit handed down unprecedented rulings questioning the well-established and scientifically based processes the FDA has for ensuring a drug’s safety (this is especially striking given that the FDA has gone so far — the medical community says further than is scientifically necessary — in ensuring the safety of mifepristone particularly, amid anti-abortion campaigns to characterize it as dangerous). Justice Department lawyers have been hammering the novelty of the rulings in their filings, warning that greenlighting these opinions means flinging wide the floodgates for all kinds of challenges to the FDA’s authority.
Read the new lawsuit here: