“Once a drug has been through the rigorous FDA review process and received approval, federal law protects the right to market the drug,” said GenBioPro CEO Evan Massingill. “GenBioPro will use all regulatory and legal tools to protect access to mifepristone for patients and providers.”
GenBioPro—the pharmaceutical company that makes a generic version of the abortion pill mifepristone—sued the U.S. Food and Drug Administration (FDA) on Wednesday, April 19, in Maryland federal court, where the agency is headquartered. The suit seeks an order to compel the FDA to allow GenBioPro to continue to sell the medication in the United States. GenBioPro estimates their generic medication comprises two-thirds of the mifepristone in the United States.
The lawsuit came in response to rulings in a Texas case that attempt to remove the medication from the market. The FDA approved GenBioPro’s 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.
“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,” said GenBioPro CEO Evan Masingill. “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. 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 argued the company has the right to preserve the drug’s availability under the federal Food, Drug and Cosmetic Act (FDCA), the FDA’s regulations and the company’s constitutional rights guaranteed by the Fifth Amendment of the United States Constitution.
“The FDCA and FDA regulations authorize the HHS secretary—and only the secretary—to immediately suspend a drug approval when the secretary determines, based on specifically enumerated findings of fact, that the drug presents ‘an imminent hazard to the public health,’” according to the complaint.
GenBioPro seeks an order preventing the FDA “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.”
GenBioPro is represented by Democracy Forward Foundation and the law firms of Arnold & Porter and Kellogg, Hansen, Todd, Figel & Frederick.
“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.
On April 7, a federal district judge in Texas purported to stay the FDA’s approval of mifepristone, including the approval of GenBioPro’s generic mifepristone in 2019. In his ruling, the Trump-appointed Matthew Kacsmaryk said that the FDA improperly approved mifepristone. On the same day, another federal district court in Washington state issued an order that the FDA cannot alter the availability of mifepristone in 17 states and the District of Columbia.
On April 12, the Fifth Circuit Court of Appeals reversed the Texas court’s decision in part, but affirmed the court’s order to stay the FDA’s the approval of GenBioPro’s product. Then on April 13, the federal court in Washington state said that the FDA must follow his order, “irrespective” of the Fifth Circuit appeals court.
The defendants in the lawsuit—who are the FDA and the pharmaceutical company Danco, which makes the brand-named mifepristone, Mifeprex—filed an emergency stay request with the Supreme Court, which has stayed the lower court decisions until April 21 while it considers the case.
GenBioPro is not a party to the Texas case before the Supreme Court, but has filed a brief in the case.
Abortion rights supporters across the U.S. took to the streets this weekend in nationwide protests against the new attempted restrictions on the drug. Over 700 pharmaceutical executives have signed a letter objecting to the Texas ruling, which could destabilize the drug market in the United States.
“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.
GenBioPro said they have sent the FDA a “series of communications” about the status of their medication, but the agency has failed to confirm it will follow longstanding federal law amidst what is “public chaos and concern regarding market disruption for the medication.”
“Nothing in the FDCA or U.S. Constitution permits FDA to violate federal law in determining how to navigate these court orders or other external events,” according to the complaint. “On the contrary, Congress specifically mandated and the Constitution requires a procedure the agency must follow before it deprives [GenBioPro] of its rights. That procedure is required regardless of external attempts to interfere with FDA’s drug approvals.”
Last January, GenBioPro filed another lawsuit challenging state restrictions on abortion pills. In that case, the company sued West Virginia in federal court, alleging that a state abortion ban passed in the aftermath of Dobbs and other restrictions on medication abortion violate the Supremacy Clause and the Commerce Clause of the U.S. Constitution.
“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,” said GenBioPro CEO Evan Massingill. “GenBioPro will use all regulatory and legal tools to protect access to mifepristone for patients and providers.”
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