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Maker of generic abortion pill sues feds to protect access  

The company seeks an order preventing the FDA from taking mifepristone off the market if abortion opponents prevail in their fight to overturn the drug’s approval.

BALTIMORE (CN) — The maker of the first generic version of abortion pill mifepristone to be approved by the Food and Drug Administration filed suit against the agency Wednesday seeking to preserve the medication's availability. 

"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," the company's CEO Evan Masingill said in a statement. "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."

The suit filed in a Maryland federal court seeks to enjoin the FDA from taking any action to restrict access to the abortion pill, claiming it has violated the due process clause and the Federal Food, Drug and Cosmetic Act in its response to court orders against the drug's approval.

Mifepristone has been at the center of a high-profile legal battle stemming from a Texas federal judge's decision less than two weeks ago to halt the FDA's decades-old approval of the pill after anti-abortion advocates challenged that approval.  

Before extending the pause on Wednesday, Supreme Court Justice Samuel Alito had initially given the court until midnight Wednesday to decide whether to take emergency action on a Fifth Circuit ruling that would have changed how abortion pills are administered across the country. The justices temporarily stayed enforcement of the lower court's order until Friday. 

Wednesday's lawsuit says the FDA needs to communicate better with GenBioPro about potentially unapproving the drug. 

"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," 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 [new drug] approval."

GenBioPro is the nation's only manufacturer of generic mifepristone and is responsible for an estimated two-thirds of all sales nationally. The drug is used for over 50% of abortions in the U.S. 

The company alleges in its suit that chaos will ensue if mifepristone is removed from the market. 

"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 complaint states.

Represented by attorneys with the firms Arnold & Porter and Kellogg Hansen as well as the Democracy Forward Foundation, GenBioPro claims that regardless of court orders, the Constitution affords it specific procedures before a drug can become disapproved. 

"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," the complaint states. "That procedure is required regardless of external attempts to interfere with FDA's drug approvals."

Attorney Skye Perryman with Democracy Forward said in a statement that outside interference with drug approval could hinder future medical advancements. 

"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," Perryman said. "If this were to be the case, few companies would be incentivized to develop and bring essential medications to market."

The pill allows consumers to end a pregnancy within 70 days from the first day of the patient's last menstrual period and boasts a 97% effective rate. The original manufacturer of the drug, Danco Laboratories, joined GenBioPro in the case.

FDA's approval of mifepristone dates back to 2000, when it approved a new drug application for the branded version of the drug, Mifeprex, manufactured and distributed by Danco. The agency approved GenBioPro's abbreviated new drug application to market generic mifepristone in 2019. 

"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," Masingill said. "GenBioPro will use all regulatory and legal tools to protect access to mifepristone for patients and providers."

Categories / Business, Government, Health, National

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