The company, which makes much of the abortion pill mifepristone sold in the United States, sued the Food and Drug Administration on Wednesday, a new legal salvo in a series of recent court maneuvers over the fate of the drug.
The lawsuit adds another strand to intense litigation surrounding a case filed in Texas federal court in which a consortium of anti-abortion groups is seeking to overturn the 23-year-old FDA approval for mifepristone, the first pill sold in a was used to reverse abortion therapy with two drugs.
In the new case, GenBioPro, which makes the generic version of mifepristone, is trying to prevent the FDA from complying if the courts ultimately pull 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 during the litigation, but ordered a reversal of all regulatory actions the FDA has taken against mifepristone since 2016, including the 2019 approval of the generic version of GenBioPro from the exact same drug.
That order was briefly stayed by the Supreme Court, which is expected to decide by midnight Friday whether to extend the stay until the full case can be heard.
The push to restrict abortion pills
A Texas judge’s decision to void the FDA’s approval of mifepristone, a popular abortion pill, has sparked a new conflict between supporters and opponents of abortion access in the United States.
- Under review: After an appeals court upheld some aspects of the Texas decision and the Justice Department filed an emergency motion to keep FDA approval of mifepristone, the Supreme Court is poised to consider whether to restrict medical abortion in states where abortion is legal can.
- deadline is approaching: Judge Samuel Alito issued a temporary stay to ensure mifepristone remains widely available while the Supreme Court decides whether to grant a formal stay. The stay was extended on April 19.
- A little-known drug: Abortion pills have dominated headlines, but until recently relatively few Americans were familiar with mifepristone and the concept of medical abortion, polls show.
- store pills: The Texas ruling could affect availability even if abortion is legal, and Democrat-led states have been scrambling to brace for a possible mifepristone-free future.
The GenBioPro lawsuit alleges that the FDA repeatedly failed to specify that it would follow a regulatory process established by Congress and grant the pharmaceutical company due process rights guaranteed by the Constitution if the agency was ordered to suspend its approval of the GenBioPro product or to revoke.
By leaving open the possibility that it would immediately comply with such a court order, the lawsuit argues, the FDA has “exposed GenBioPro to the risk of severe civil and criminal penalties for failing to stop supplies of mifepristone.”
The FDA issued a statement stating, “The FDA does not comment on pending litigation.”
In testimony Wednesday before the Senate Appropriations Committee, FDA Commissioner Dr. Robert M. Califf, answering questions about the Texas lawsuit, said the agency was concerned about the potential impact of the case “for the welfare of patients who need access to this drug, the pharmaceutical industry, and our ability to implement our statutory powers.” .”
Noting that the FDA is fighting the case in court, he added, “I’m just saying the FDA intends to comply with all court orders.”
Evan Masingill, CEO of GenBioPro, said Wednesday that uncertainty about the outcome of the Texas case has led to fewer mifepristone orders. “The market disruption is already pervasive, impacting orders that are in the tens of thousands of units,” he said.
The case could also have repercussions for the broader drug industry. The lawsuit alleges that it would be unprecedented for the FDA to follow a court order and immediately revoke a drug’s approval. A drug’s approval can only be revoked if the FDA determines that it poses “an imminent threat to public health,” the lawsuit states. The FDA has strongly argued in court that mifepristone is very safe, citing numerous studies showing that serious complications are rare and that fewer than 1 percent of patients require hospitalization.
“People develop drugs in this country and not others because we used to have a pretty predictable regulatory structure, and with the Texas lawsuit, that won’t be the case anymore?” said Skye Perryman, an attorney for GenBioPro and president of Democracy Forward. a centre-left legal advocacy organization. “It has industry-wide ramifications.”
GenBioPro says 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 documents filed by the FDA with the Supreme Court, in which the agency said that if the appeals court decision were to go into effect, “the generic version of the drug would be unapproved altogether.”
The company said in the lawsuit that such statements amounted to a policy decision by the federal agency and that “the FDA’s decision is flawed and unlawful.”
The lawsuit states that the FDA declined to say otherwise in response to three letters GenBioPro sent it in March and April. In those letters, GenBioPro asked the agency for clarification that it would follow the process mandated by Congress, which typically involves a detailed and lengthy review before making a decision to withdraw a drug.
The company said the FDA only responded to the first letter it sent out in March, ahead of announcing a decision in the anti-abortion groups’ lawsuit, saying only that “the FDA of course, must review the court’s opinion and order before determining what steps might be required to comply with it.”
“We are not questioning the FDA’s scientific or medical judgment,” Ms. Perryman said, “but the FDA has failed to confirm that it will respect the rights of our customers, and therefore we are seeking a court order.”
Christina Jewett provided coverage from Washington.