Generic abortion pill maker GenBioPro sues FDA over its response to orders halting drug’s approval
By Tierney Sneed
The US manufacturer of the generic version of a medication abortion drug sued the Biden administration Wednesday, the latest legal development in the dramatic court fight over abortion pills.
The company GenBioPro alleges that the US Food and Drug Administration has violated the Constitution’s Due Process Clause and other laws in how the agency has responded to recent court orders halting the approval of the generic version of the drug, mifepristone.
GenBioPro is seeking a court order that would require the FDA to go through certain procedural steps laid out under federal law before declaring its mifepristone product unapproved. The company is also asking the court to bar the federal government from taking enforcement actions against the company before the FDA had gone through statutory process of withdrawing or suspending the drug.
The new lawsuit was filed in federal court in Maryland and sets up a third legal battlefront over access to abortion pills.
The Supreme Court is currently considering whether to freeze the court orders that emerged from a separate lawsuit, filed by anti-abortion activists in Texas, that would undo the 2019 approval of the generic version of the drug and reverse other steps the FDA has taken in recent years to make abortion pills easier to obtain. Those orders have been paused by Supreme Court until 11:59 p.m. ET Wednesday, while the justices decide whether the Texas case rulings should be kept on hold for a longer period of time.
It is unclear how the new lawsuit will impact the other legal flashpoints over mifepristone. GenBioPro is not a party in the lawsuit in front of the Supreme Court. In a third case, filed in Washington state by Democratic state attorneys general, a federal judge ordered the FDA to not take any steps that would reduce mifepristone in the 18 jurisdictions behind the lawsuit, which seeks to expand access to abortion pills.
The new lawsuit provides a behind-the-scenes view of the fallout from the anti-abortion litigation in Texas. The complaint zeroes in on how the federal government has said in court filings in that case that recent court orders have the effect of making GenBioPro’s product “misbranded” and leave the generic version of the drug “without an effective drug approval.”
The company argues that the FDA is causing GenBioPro “imminent, catastrophic, and irreparable harm” by making those characterizations while ignoring the “statutory and regulatory procedures” for withdrawing a drug.
The lawsuit describes several attempts by GenBioPro to get assurances from the FDA that it would go through the multistep withdrawal process mandated by Congress before pulling the drug from the market. The company alleges that the agency did not offer those assurances, nor did it respond to the company’s requests for a non-enforcement directive that would shield the company, its business partners and its customers from any FDA enforcement actions based on the court orders in the Texas case.
“GenBioPro faces a credible, serious threat of FDCA enforcement if it attempts to continue producing and marketing mifepristone,” the lawsuit says, referring to the Food, Drug, and Cosmetic Act, which sets out how the FDA goes about its regulatory process. “With the specter of criminal prosecution looming, GenBioPro may be obligated to undertake recalls, cancel contracted manufacturing and hold or destroy perishable inventory.”
GenBioPro’s lawsuit names as its defendants the FDA, the Justice Department and Department of Health and Human Services.
The FDA and the Justice Department declined to comment on the lawsuit. HHS referred CNN to the response from the FDA.
This story has been updated with additional details.
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CNN’s Jessica Schneider and Carma Hassan contributed to this report.
