The company that makes a majority of the abortion pill mifepristone sold in the United States sued the Food and Drug Administration on Wednesday, a new legal volley in a string of recent court manipulations over the fate of the drug. The lawsuit adds another strand to the Intense legal battle underway over a case filed in federal court in Texas in which a consortium of anti-abortion groups are seeking to overturn the FDA’s 23-year-old approval of mifepristone, the first pill used in a two-drug medication abortion regime. In the new case, GenBioPro, which makes the generic version of mifepristone, seeks to block the FDA from complying if the courts ultimately order mifepristone off the market. The case was filed in the US District Court of Maryland.Earlier this month, the federal judge in the Texas case issued a preliminary ruling invalidating the approval of mifepristone. Last week a federal appeals court panel said the drug could remain on the market while the case was being litigated, but it ordered a reversal of all regulatory actions the FDA has taken on mifepristone since 2016, which include the approval in 2019 of GenBioPro’s generic version of the exact same drug. That order has been briefly paused by the Supreme Court, which will decide by midnight on Wednesday whether it will extend the stay case until the full be heard. The Push to Restrict Abortion Pills The decision by a Texas judge to invalidate the FDA’s approval of mifepristone, a common abortion pill, has set off a new clash between supporters and opponents of abortion access in the United States. Under Review: After an appeals court order let stand some aspects of the Texas decision and the Justice Department filed an emergency request to preserve the FDA’s approval of mifepristone, the Supreme Court is poised to consider whether medication abortion can be curtailed in states where abortion is legalatuous.Tempor : Justice Samuel Alito issued a temporary stay ensuring that mifepristone would remain widely available while the Supreme Court decides whether to grant a formal stay. A Little-Known Drug: Abortion pills have dominated headlines, but, until recently, relatively with few Americans mifepristone and the concept of medication abortions, polls show. Stockpiling Pills: The Texas ruling could affect availability even where abortion is legal, and states led by Democrats have been scrambling to adjust to a possible future without mifepristone. The GenBioPro claims the FDA has repeatedly failed to stipulate that it would follow a regulatory process established by Congress and afford the drug company due process rights guaranteed by the Constitution if the agency was ordered to suspend or revoke its approval that of GenBioPro’s product. By leaving it open the possibility Immediately obey such a court order, the lawsuit argues, the FDA has “left GenBioPro at risk of severe civil and criminal penalties if it does not cease shipments of mifepristone.” Evan Masingill, GenBioPro’s chief executive, said Wednesday that undoubtedly the The Texas case has led to fewer orders of mifepristone. “The market disruption is already pervasive, impacting orders that include tens of thousands of units,” he said. The case could also have implications for the broader drug industry. The suit claims that it would be unprecedented for the FDA to follow a court order to immediately revoke the approval of a drug. A drug’s approval can only be revoked if the FDA determines that it presents “an imminent hazard to the public health,” the lawsuit says. The FDA has forcefully argued in court that mifepristone is very safe and cited scores of studies showing that serious complications are rare and that less than 1 percent of patients need hospitalization.”People develop drugs in this country and not in others because we’ve typically had pretty predictable regulatory structure, and with the Texas lawsuit, is that becoming not the case?” said Skye Perryman, a lawyer for GenBioPro and president of Democracy Forward, a center-left legal advocacy organization. “That has industry wide implications.” GenBioPro says that it supplies about two-thirds of the drug sold in the United States and that it sold more than 850,000 units of the drug between 2017 and 2020. GenBioPro’s lawsuit cites filings the FDA submitted to the Supreme Court, in which the agency said If the appeals court decision were to take effect, “the generic version of the drug would cease to be approved altogether.” The company said in the lawsuit that such statements amounted to a policy decision by the federal agency and that “the FDA decision is erroneous and unlawful.”The suit says that the FDA has declined to say otherwise in response to three letters GenBioPro sent it in March and April. In those letters, GenBioPro asked the agency to clarify that it would adhere to the congressionally-mandated process that Typically involves a detailed and lengthy review before any decision about withdrawing a drug is made. The company said that the FDA had responded to only the first letter, sent in March before any decision was announced in the anti-abortion groups’ lawsuit, and that it said only that the “FDA will, of course, need to review the Court’s opinion and order before determining what steps may be necessary to comply with it.” “We are not challenging FDA’s scientific or medical judgment,” Ms. Perryman said, “but FDA has failed to confirm it will respect our clients’ rights and so we are seeking a court order.”
