Abortion pill maker sues FDA to protect drug if a court orders it off the market

The company that makes a majority of the abortion pill mifepristone sold in the United States sued the Food and Drug Administration on Wednesday, another legal salvo in a series of recent court maneuvers over the drug’s fate.

The lawsuit adds another layer to the intense legal battle ongoing over a case filed in federal court in Texas in which a consortium of anti-abortion groups is trying to overturn the FDA’s 23-year-old approval of mifepristone, the first pill used in a two-stage abortion regimen medications.

In the new case, GenBioPro, which makes the generic version of mifepristone, is trying to block the FDA from complying if the courts eventually 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 injunction invalidating the approval of mifepristone. Last week, a federal appeals court panel said the drug could remain on the market while the case was heard, but it ordered a reversal of all regulatory actions the FDA has taken on mifepristone since 2016, which includes approval in 2019 of GenBioPro’s generic version of the exact same drug.

That ruling has been put on hold by the Supreme Court, which is expected to decide at midnight on Friday whether it will extend the stay until the entire case can be heard.

The GenBioPro lawsuit alleges that the FDA has repeatedly failed to determine that it would follow a regulatory process established by Congress and give the drug company due process rights guaranteed by the Constitution if the agency was ordered to suspend or revoke approval of GenBioPro’s product.

By leaving open the possibility that it would immediately obey such a court order, the lawsuit alleges, the FDA has “left GenBioPro at risk of severe civil and criminal penalties if it does not stop shipments of mifepristone.”

The FDA released a statement saying, “The FDA does not comment on pending litigation.”

In testimony Wednesday before the Senate Appropriations Committee, FDA Commissioner Dr. Robert M. Califf, who fielded questions about the Texas lawsuit, said the agency was concerned about the potential implications of the case, “from the well-being of patients who need access to this drug , the pharmaceutical industry and our ability to implement our statutory authority.”

He noted that the FDA was fighting the case in court, adding “I just want to say that the FDA intends to comply with any court orders.”

Evan Masingill, GenBioPro’s CEO, said Wednesday that uncertainty about the outcome of the Texas case has led to fewer orders for mifepristone. “The market disruption is already pervasive, affecting orders that include tens of thousands of units,” he said.

The case may also have consequences for the wider pharmaceutical 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 poses “an imminent danger to public health,” the lawsuit says. The FDA has forcefully argued in court that mifepristone is very safe, citing numerous studies showing that serious complications are rare and that less than 1 percent of patients require hospitalization.

“People develop drugs in this country and not in others because we’ve usually had a pretty predictable regulatory structure, and with the Texas lawsuit, isn’t that going to be the case?” said Skye Perryman, attorney for GenBioPro and president of Democracy Forward, a center-left legal advocacy organization. “It has industry-wide implications.”

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 filings the FDA filed with the Supreme Court, in which the agency said that if the appeals court’s decision were to take effect, “the generic version of the drug would cease to be approved entirely.”

The company said in the lawsuit that such statements constituted a policy decision by the federal agency and that “the FDA decision is erroneous and illegal.”

The suit says the FDA has refused 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 follow the congressionally mandated process that typically involves a detailed and lengthy review before any decision to withdraw a drug is made.

The company said the FDA had only responded to the first letter, sent in March before any decision was announced in the anti-abortion groups’ lawsuit, saying only that “the FDA will, of course, need to review the court’s opinion and order before deciding what steps to take.” be necessary to comply with it.”

“We are not challenging the FDA’s scientific or medical judgment,” Perryman said, “but the FDA has not confirmed that it will respect our clients’ rights, and so we are seeking a court order.”

Christina Jewett contributed reporting from Washington.