A federal judge in Texas has extended the deadline to February 24 in a lawsuit to overturn the Food and Drug Administration’s approval of the abortion pill.
Judge Matthew Kacsmaryk on Thursday ordered one of the companies that makes the pill, Danco Laboratories, to oppose attempts to take the drug off the US market. The anti-abortion doctors who originally filed the lawsuit will then have until February 24 to respond.
“The briefing will then be closed on this matter barring ‘extraordinary or exceptional circumstances,'” Kacsmaryk wrote.
The Alliance for Hippocratic Medicine, a coalition of anti-abortion physicians, sued the FDA in November over its more than two-decade-old approval of mifepristone.
When combined with misoprostol, mifepristone is the most common method of abortion in the United States, accounting for about half of all abortions.
“Forcing the FDA to withdraw a long-standing approval would upset the government’s agency of determining whether drugs are safe and effective and would directly and immediately harm Danco by shutting down its business,” attorneys for abortion pill maker Danco Laboratories told the court on Friday.
Abortion rights group NARAL Pro-Choice America said in an analysis released Friday that 40 million women would lose access to the abortion pill if the Alliance for Hippocratic Medicine succeeded and mifepristone were effectively banned.
The Alliance argued that the FDA abused its authority by approving mifepristone in an accelerated process in 2000 for new drugs that offer more benefit to patients with serious or life-threatening illnesses than what is otherwise available on the market.
In its response, the FDA called the lawsuit “extraordinary and unprecedented.” Lawyers for the agency said they could not find any previous example of a court guessing after the fact of an FDA decision approving a drug.
The agency also said mifepristone was not approved through an expedited route. More than four years passed from the initial application to the approval of the pill.
The FDA has approved mifepristone as a safe and effective method of terminating an early pregnancy based on extensive scientific evidence, the agency’s attorneys wrote. Decades of experience of thousands of women have confirmed that drug therapy is safer than surgical abortion or childbirth, the lawyers argued.
The FDA warned that withdrawing mifepristone from the US market would result in poorer health outcomes for patients who rely on the pill to safely terminate pregnancies. It would also weaken FDA’s drug approval powers and hamper development by creating regulatory uncertainty in the market.
“If long-standing FDA drug approvals were so easily waived decades after they were granted, pharmaceutical companies could not confidently rely on FDA approval decisions to develop the pharmaceutical drug infrastructure Americans depend on to treat a variety of health conditions,” he said the attorneys for the Biden administration wrote.
Two separate lawsuits also seek to overturn state restrictions on mifepristone, arguing that they conflict with FDA regulations.
GenBioPro, another company that makes the pill, is suing to have West Virginia’s ban overturned for these reasons. A doctor in North Carolina has also sued to lift restrictions on mifepristone in that state.
Republican attorneys general in 20 states recently warned CVS and Walgreens not to ship the abortion pill in their states, saying they would take legal action.
CV And Walgreensthe country’s two largest drugstore chains, are in the process of gaining approval for the sale of mifepristone in states where it is legal.
The FDA recently changed its regulations to allow retail pharmacies to dispense prescription drugs as long as they are certified.