GenBioPro Sues FDA To Keep Generic Mifepristone Available; Supreme Court Delays Its Decision
Executive Summary
GenBioPro asks Maryland district court to prevent FDA from taking enforcement actions against it if Supreme Court allows stay of approval of mifepristone. Justice Samuel Alito extends deadline to respond until midnight Friday.
The legal battle over mifepristone took a sharp twist with GenBioPro suing the US Food and Drug Administration to prevent it from taking civil and criminal enforcement actions against the company if the US Supreme Court does not halt a Texas district court order staying approval of the medication abortion drug. The suit also asks the court to require FDA to follow regulatory procedures before altering the availability or status of its generic mifepristone product.
Janet Woodcock, FDA’s deputy principal commissioner, laid out what the agency and sponsors will have to do if the order goes into effect in a declaration included in the Department of Justice’s application to the Supreme Court for an emergency stay of the decision by US District Judge Matthew Kacsmaryk of the Northern District of Texas. She said mifepristone would become misbranded, approval of GenBioPro’s generic would be stayed altogether and the company would have to file another abbreviated new drug application. (Also see "FDA's Woodcock To Supreme Court: Mifepristone Ruling Will Create 'Significant Chaos’" - Pink Sheet, 15 Apr, 2023.)
GenBioPro’s suit was filed the same day the Supreme Court had been set to decide on the appeal of the ruling that concerned the firm. Justice Samuel Alito had issued an administrative stay of Kacsmaryk’s order until 11:59 p.m. (EDT) on 19 April. That afternoon, he issued an order extending the stay until 11:59 p.m. (EDT) on Friday, 21 April.
In its complaint, filed in the US District Court for the District of Maryland, GenBioPro says that under the Fifth Amendment to the U.S. Constitution and the Federal Food, Drug, and Cosmetic Act, FDA may not deprive the company of its protected ANDA rights without adequate due process.
GenBioPro said the FDA has not provided it with process of any kind or provided any guidance on how the agency might effect a “stay” of GenBioPro’s ANDA, while at the same time complying with a Washington district court order requiring FDA to refrain from “altering the status quo” on mifepristone availability in Maryland, 16 other states, and the District of Columbia.
“Amidst this tumult, GenBioPro has repeatedly requested assurances from FDA that FDA will follow its own procedures and adhere to the mandates of the FDCA and the U.S. Constitution – mandates that apply to FDA’s actions with respect to all drugs – in its regulation of mifepristone,” the complaint states.
“Notwithstanding the exigent circumstances and the numerous tools available to FDA, FDA has repeatedly refused to assure GenBioPro or the public that it will afford GenBioPro adequate procedures before suspending GenBioPro’s ANDA approval,” the suit says. “Nothing in the FDCA or in the U.S. Constitution permits FDA to violate federal law in determining how to navigate these court orders or other external events.”
No ’Imminent Hazard’ To Public Health
GenBioPro said Congress delegated the secretary of the Department of Health and Human Services the sole legal authority to “suspend” a drug without a pre-deprivation process, and the Secretary may do so only upon a finding that the drug poses an “imminent hazard to the public health.” Upon such a finding, the approval holder must be given the opportunity for an expedited hearing, the complaint states.
The suit says that according to FDA, the extreme sanction of suspension has been invoked only once in history, when a “rare but serious side effect” of phenformin was found to have a 50% mortality rate.
“Without the requisite ‘imminent hazard’ finding – and the procedural protections that accompany such a finding – FDA may not deprive GenBioPro of its protected property and liberty interests in marketing its ANDA for mifepristone,” the complaint says.
GenBioPro sells only two products, mifepristone and misoprostol, the two drugs used in the medication abortion regimen.
The company requests a judgment declaring that FDA and HHS are required to follow statutory and regulatory procedures for any suspension of GenBioPro’s approved ANDA for mifepristone, that its decision to characterize the product as “misbranded” and GenBioPro as “without an effective drug approval” for mifepristone is erroneous and unlawful, and that the agency may not lawfully bring an enforcement action against GenBioPro for distribution of misbranded or unapproved drugs without first following the statutory and regulatory procedures for suspension of approval.
Broad Industry Support For FDA
Judge Kacsmaryk issued a preliminary injunction on 7 April staying the effective date of FDA’s 2000 approval of Danco Laboratories' branded mifepristone drug Mifeprex and stayed the order from going into effect for seven days to give FDA and Danco, which intervened as a defendant in the case, Alliance for Hippocratic Medicine v. FDA, time to seek an emergency stay with the US Court of Appeals for the Fifth Circuit. (Also see "What’s Next For FDA In Face Of Opposing Mifepristone Injunctions" - Pink Sheet, 9 Apr, 2023.)
The Fifth Circuit issued an order on 12 April staying Kacsmaryk’s order regarding the 2000 approval but leaving in place the stay of all agency actions since modification of the mifepristone Risk Evaluation and Mitigation Strategy (REMS) in 2016, including the 2019 approval of GenBioPro’s generic, the sole generic approved by FDA. (Also see "Fifth Circuit Mifepristone Ruling May Temporarily Halt Pharmacy Dispensing, Generic Approval" - Pink Sheet, 13 Apr, 2023.)
A group of anti-abortion doctors and physician groups filed suit against FDA last November asking the court to order FDA to withdraw or suspend the approvals of mifepristone. Judge Kacsmaryk said he was exercising authority under the Administrative Procedure Act to stay the approvals of the drug.
His ruling evoked massive opposition, including from the biopharma industry. A group of 169 companies, senior executives, board members and investors filed an amicus brief to the Fifth Circuit asking it to stay, and ultimately reverse, Judge Kacsmaryk’s order saying it would radically alter the new drug application process. (Also see "Biopharma Companies – But Not PhRMA – Argue That Mifepristone Ruling ‘Radically Alters’ NDA Process" - Pink Sheet, 12 Apr, 2023.)
The Pharmaceutical Research and Manufacturers of America filed its own brief to the Supreme Court supporting the FDA and Danco’s applications for a stay. (Also see "PhRMA Jumps Into Battle Over Mifepristone Regulation With Supreme Court Filing" - Pink Sheet, 15 Apr, 2023.)
Many other groups filed amicus briefs with the Supreme Court calling for a stay, including GenBioPro and 10 former FDA officials. Signatories to the latter brief included former Acting Commissioner and FDA Chief Scientist Stephen Ostroff and former Principal Deputy Commissioner of Food and Drugs Rachel Sherman.