GenBioPro sues to prevent FDA from ‘upending’ generic abortion pill approval

GenBioPro (GBP) has filed a lawsuit before the U.S. District Court for Maryland, asking the court to preemptively block the FDA from ‘upending’ the generic abortion pill company’s 2019 approval to distribute mifepristone.

While GBP acknowledged that its “core business is providing drugs used for medication abortion,” it claimed FDA changes would cause the generic abortion pill maker to potentially “undertake recalls, cancel contracted manufacturing and hold or destroy perishable inventory” and that it would suffer “irreparable financial and reputational harm.”

“GenBioPro brings this suit to enjoin the U.S. Food and Drug Administration (‘FDA’) from depriving GenBioPro of its constitutional and statutory rights to market mifepristone without affording GenBioPro due process of law, and to prevent Defendants from upending nearly a quarter-century of public reliance on a safe and effective drug by bringing criminal and civil enforcement actions against GenBioPro, its agents, manufacturers, distributors, partners, and customers,” the company, represented by Arnold & Porter, Kellogg, Hansen, Todd, Figel & Frederick, as well as Democracy Forward, wrote in the court document.

Legal actions sparking the lawsuit

The move by GBP follows lawsuits — Alliance for Hippocratic Medicine (AHM) v. FDA as well as Washington State v. FDA — surrounding legitimacy of the FDA approval process of the drug.

In their legal claim, GBP accused the FDA of threatening to “misbrand” the abortion pill if the AHM case prevailed, predicting that ‘[t]he generic version of the drug would cease to be approved altogether.”

“Over the past two weeks, rulings from four federal courts have purported to dramatically alter the landscape of FDA’s regulation of mifepristone,” GBP claimed. “If the AHM Fifth Circuit Order goes into effect, the result will be chaos,” GBP wrote, later clarifying that “GenBioPro was not and is not a party to the AHM action.”

That Fifth Circuit Court ruling would turn the clock back on FDA approvals to pre-2016, essentially halting the generic approval under GenBioPro, which was issued in 2019.

Pre-2016 REMS requirements would also roll back the approved gestational limits for prescribing or dispensing mifepristone from 10 weeks of pregnancy back to seven weeks of pregnancy, require that only licensed doctors prescribe the drug in-person (eliminating mail order and pharmacy dispensing), and require that non-fatal adverse events (complications) again be reported to the FDA.

They referred to that move as “erroneous and unlawful” and claimed that this would deny GenBioPro of “any process before depriving it of its statutorily and constitutionally protected ANDA rights.”

“FDA and HHS confirmed that they have made a final policy decision with respect to GenBioPro’s ANDA approval. FDA and HHS have decided that they will characterize GenBioPro’s mifepristone as ‘misbranded’ and characterize GenBioPro as ‘without an effective drug approval’ for generic mifepristone,” GBP claimed.

“GenBioPro faces a credible, serious threat of FDCA enforcement if it attempts to continue producing and marketing mifepristone. With the specter of criminal prosecution looming, GenBioPro may be obligated to undertake recalls, cancel contracted manufacturing and hold or destroy perishable inventory,” the abortion pill manufacturer wrote. “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.”

GBP seeks clarification by court on Washington State ‘stay’

“FDA… has not provided any guidance to GenBioPro on how it might effect a ‘stay’ of GenBioPro’s ANDA, while at the same time complying with the Washington Order, which requires FDA to refrain from ‘altering the status quo’ in Maryland, 16 other states, and the District of Columbia,” GBP wrote.

GBP is referring to the Washington State v. FDA lawsuit filed by pro-abortion politicians, where on April 7, 2023, U.S. District Judge Thomas O. Rice granted a preliminary injunction to bar the FDA from “altering the status quo and rights as it relates to the availability of Mifepristone under the current operative January 2023 Risk Evaluation and Mitigation Strategy under 21 U.S.C. § 355-1 in Plaintiff States.”

“Nonetheless, Defendants have declared that, absent a stay, GenBioPro’s generic mifepristone will ‘become misbranded’ and GenBioPro will be ‘without an effective drug approval’ as a result of the AHM Order and AHM Fifth Circuit Order,” the lawsuit reads.

“FDA and the other Defendants have thereby left GenBioPro at risk of severe civil and criminal penalties if it does not cease shipments of mifepristone” and “GenBioPro will suffer threats to its core business and irreparable financial harm,” the abortion pill manufacturer wrote.

GBP claims unprecedented circumstances

“These circumstances are unprecedented. No court in history has ever ‘stayed’ or ‘suspended’ a longstanding FDA approval, and FDA has no template for responding to—or implementing—those decisions,” GBP claimed.

While GBP claims a court ruling is unprecedented, they failed to point out that in the Washington State case, the pro-abortion plaintiffs asked the court to force the FDA to remove the drug from under the REMS safety system. In addition, just this month, the FDA made a decision to withdraw approval of another drug, MAKENA,. even though it had previously been approved by the FDA since 2011.

In addition, GBP later identified another case, writing, “According to FDA, the extreme sanction of suspension has been invoked only once in history, when a ‘rare but serious side effect’ of the drug phenformin, in use by hundreds of thousands of patients, was found to have a 50 percent mortality rate.”

GenBioPro history

GenBioPro was approved as the generic drug maker by the FDA in 2019, and just like the originally approved and highly secretive abortion pill manufacturer Danco Laboratories was seeded with investment dollars from the pro-abortion David and Lucile Packard Foundation, GenBioPro has also been seeded with funding from this abortion philanthropy group.

According to GenBioPro’s lawsuit, the abortion pill company sells only “generic mifepristone and misoprostol, which make up the FDA-approved two-drug regimen for medication abortion.”

“Sales of the two drugs are essentially the company’s sole source of product revenue” they claimed. The company previously admitted they had “captured a significant share of the nationwide market for mifepristone” but now, according to multiple media sources, GBP allegedly supplies roughly two-thirds of U.S. abortion pills.

“Since 2019, when GenBioPro received approval from FDA to sell generic mifepristone, GenBioPro has marketed and sold more than 850,000 units of the product throughout the United States,” GBP wrote. “Between 2017 and 2020 (the year after GenBioPro began marketing its product), medication abortions in the United States increased by 45 percent, even as the overall number of abortions has declined since the 1990s. Medication abortion now accounts for the majority of pregnancy terminations in the United States.”

In response to the court cases, FDA Commissioner Dr. Robert Califf assured a Congressional panel that the FDA “intends to comply with any court orders.”

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