Abortion pill manufacturer sues to keep FDA approval amid court battle
Breccan F. Thies
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Abortion pill manufacturer GenBioPro filed suit against the Food and Drug Administration to maintain its ability to market the drug.
GenBioPro manufactures a generic version of mifepristone, the first drug in a two-step chemical abortion process, which it argued “provides patients with a safe, effective, noninvasive medication option for terminating a pregnancy.”
OB-GYNS DISPUTE SAFETY OF ABORTION PILL AMID COURT BATTLE
The lawsuit, which was filed in a federal court in Maryland, comes as the Supreme Court reviews a 5th Circuit ruling on a Texas decision invalidating the FDA’s approval of the pill.
The company seeks to bar the FDA from “depriving GenBioPro of its constitutional and statutory rights to market mifepristone without affording GenBioPro due process of law.”
Noting the legal landscape, which has seen four different actions from separate courts with one awaiting Supreme Court review, GenBioPro argued, “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.”
The 5th Circuit Court of Appeals halted some of the Texas decision while maintaining stays on more recent FDA changes that expanded access to the pill through telemedicine, mail, and retail pharmacies. The case is before the Supreme Court with an expected ruling Wednesday.
“If the [Alliance for Hippocratic Medicine] Fifth Circuit Order goes into effect, the result will be chaos,” the manufacturer stated.
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One decision out of Washington directed the FDA not to alter the “status quo” on approval in 17 states, one of which is Maryland. The abortion pill-maker maintained it has no guidance as to how to comply with the Texas decision to effect a “stay” while not “altering the status quo.”
According to GenBioPro, the company “repeatedly” asked the FDA for drug suspension procedures. Moreover, the company argued that Fifth Amendment due process rights and the Federal Food, Drug, and Cosmetic Act do not allow the “FDA to violate federal law in determining how to navigate these court orders or other external events” because of a congressionally mandated procedure.