Nation’s only generic manufacturer sues to compel compliance
with FDA’s laws and regulations
LAS VEGAS – GenBioPro, the nation’s only manufacturer of generic mifepristone which comprises an estimated two-thirds of the mifepristone sold in the United States, filed a legal challenge today against the US Food and Drug Administration (“FDA”). The action, filed in the Maryland federal district court where the agency is headquartered, seeks to compel FDA to preserve availability to mifepristone in accordance with the federal Food, Drug, and Cosmetic Act (“FDCA”), the agency’s own regulations, and protections provided to companies by the fifth amendment of the United States Constitution. Using its regulations and in line with federal law, FDA has meticulously and repeatedly reviewed mifepristone over 23 years. Now external attempts to alter the medication’s approval status and the agency’s reaction to those attempts have caused chaos and uncertainty, to the detriment of the company and health care providers nationwide, as well as the public health.
Under federal law, FDA is required to follow processes before taking any action to alter the approval or availability of a medication. The complaint alleges that in response to a series of communications that GenBioPro has sent the agency, FDA has failed to provide any process to GenBioPro or to confirm it will follow longstanding federal law amidst what is public chaos and concern regarding market disruption for the medication. The suit seeks to compel compliance with federal law and to compel FDA to refrain from taking any action that would alter the availability of mifepristone or its approval status.
“GenBioPro was founded on the belief that all people–regardless of their income, gender, race, or zip code–should be able to access essential, evidence-based medication. In today’s action, we are seeking to enforce rights Congress provided to us, as well as protections in the United States Constitution, which protect our company and our health care provider customers,” said GenBioPro CEO Evan Masingill. “Notably, today’s matter does not question the scientific expertise or judgment of FDA; rather, it seeks to enforce the rights GenBioPro has under federal law and FDA’s regulatory structure.”
GenBioPro received FDA approval for generic mifepristone in 2019 following more than a decade of development. Mifepristone and misoprostol, the two medications in the FDA-approved medication abortion regimen, are the company’s only two products. Last year, GenBioPro was recognized on Fortune’s list of companies changing the world for its commitment to enhancing access to mifepristone.
In the action, GenBioPro is represented by Arnold & Porter, Kellogg, Hansen, Todd, Figel & Frederick, and Democracy Forward Foundation who released the following statements:
“Mifepristone has a long history of safety and efficacy that FDA has repeatedly reviewed and affirmed. Congress itself has deemed the medication essential and GenBioPro should not be deprived of its rights, nor should the public be deprived of this medication without proper process,” said Daphne O’Connor of Arnold & Porter.
“Our case today is intended to protect GenBioPro, its customers, and the public against unlawful attempts to interfere with FDA’s long-standing approval and regulation of mifepristone,” said David Frederick of Kellogg Hansen.
“Companies like GenBioPro rely on their regulators and the laws Congress has passed to govern their operations. There are industry wide implications if far-right external interest groups are able to interfere with drug availability in the country without the legal and regulatory protections provided by Congress. If this were to be the case, few companies would be incentivized to develop and bring essential medications to market,” said Skye Perryman of Democracy Forward Foundation.
Earlier this month, a federal judge in Texas issued an order purporting to “stay” approval of mifepristone in response to litigation from anti-science activists. That order, which has no basis in law or in fact, is now the subject of emergency stay requests. Last week, following an emergency petition to the Supreme Court filed by the federal government and the company that sought initial approval for mifepristone in 2000 and supported on briefs by GenBioPro, industry leaders, and former government officials, the Supreme Court temporarily stayed enforcement of the lower court’s order. Another federal district court in Washington has issued an order holding that FDA cannot alter the availability of mifepristone in 17 states and the District of Columbia.
“In the United States, once a drug has been through the rigorous FDA review process and received approval, federal law protects the right to market the drug. GenBioPro will use all regulatory and legal tools to protect access to mifepristone for patients and providers,” said GenBioPro CEO Evan Massingill.
GenBioPro’s complaint filed today states that “Nothing in the FDCA or US Constitution permits FDA to violate federal law in determining how to navigate these court orders or other external events. On the contrary, Congress specifically mandated and the Constitution requires a procedure the agency must follow” before it deprives a company like GenBioPro of its rights. “That procedure is required regardless of external attempts to interfere with FDA’s drug approvals,” the complaint notes.
In January, GenBioPro brought a post-Dobbs challenge to West Virginia’s unlawful attempt to ban medication abortion, a move that disproportionately affects those living in rural areas and people with low incomes and violates Congress’s express instruction that FDA alone regulate access to mifepristone, and that the agency must do so in a way that does not “unduly burden” patient access. That case remains pending.