The company that makes a generic version of the common abortion pill mifepristone sued the Food and Drug Administration (FDA) on Wednesday in an effort to preserve access to the drug amid the chaotic fight across multiple federal courts.
GenBioPro said it wants to preemptively block FDA from any action that would disrupt access to the drugs, including pulling its 2019 approval, if the Supreme Court declines to stop sweeping restrictions from taking effect.
The lawsuit, filed in a Maryland federal court, argues that if FDA suspends approval to comply with a Texas court order, it would cause “imminent, catastrophic, and irreparable harm” to the company.
GenBioPro said it makes about two thirds of the mifepristone sold in the U.S.
The company said FDA doesn’t have the authority to pull the drug’s approval without a finding of “imminent hazard to the public health,” and without due process.
The lawsuit was filed the same day the Supreme Court delayed until Friday a decision on whether to pause a lower court’s ruling while the Biden administration appeals.
A decision by the 5th U.S. Circuit Court of Appeals last week would unwind all moves made by FDA after 2015 to increase access to mifepristone.
Those changes include increasing the gestational age of when mifepristone can be used to up to 10 weeks of pregnancy, allowing the medication to be mailed to patients, allowing providers other than physicians to prescribe the drug and approving the generic version made by GenBioPro.
If the appellate court’s order takes effect, “the result will be chaos,” GenBioPro warned.
“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 company argued.
The lawsuit said FDA has not provided any guidance to GenBioPro about the process for suspending approval and has not responded to repeated requests for clarification.
FDA says it does not comment on pending litigation.
The agency has “repeatedly refused to assure GenBioPro or the public that it will afford GenBioPro adequate procedures before suspending GenBioPro’s … approval,” the lawsuit alleged.
Further complicating the legal landscape is an order by Judge Thomas Rice in Washington state, which bars FDA from “altering the status quo” for mifepristone access in 17 states and Washington, D.C.