A federal judge in Texas has extended until February 24 the deadline in a lawsuit seeking to overturn the Food and Drug Administration’s approval of the abortion pill.
Judge Matthew Kaczmarik on Thursday ordered one of the companies that make the pill, Danco Laboratories, to resist an attempt to pull the drug from the US market. The anti-abortion doctors who initially filed the lawsuit then have until February 24 to respond.
“The briefing will then be closed on the matter, absent ‘exceptional or extraordinary circumstances,'” Kaczmarik wrote.
The Alliance for Hippocratic Medicine, a coalition of doctors who oppose abortion, sued the FDA in November over its approval of mifepristone more than two decades ago.
Used in combination with misoprostol, mifepristone is the most common method of terminating a pregnancy in the US, accounting for about half of all abortions.
Abortion rights group NARAL Pro-Choice America said in an analysis released Friday that 40 million women would lose access to abortion pills if the Alliance for Hippocratic Medicine succeeds and mifepristone is effectively banned.
The alliance claims the FDA abused its power by approving mifepristone in 2000 through an accelerated process for new drugs that benefit patients with serious or life-threatening illnesses beyond what is otherwise available on the market.
In its response, the FDA called the case “extraordinary and unprecedented.” Attorneys for the agency said they could find no previous example of a court second-guessing an FDA decision to approve a drug.
The FDA approved mifepristone as a safe and effective method of terminating early pregnancy based on extensive scientific evidence, the agency’s lawyers wrote. Decades of experience among thousands of women have confirmed that the drug regimen is safer than surgical abortion or childbirth, advocates say.
The FDA has warned that withdrawing mifepristone from the US market will lead to worse health outcomes for patients who rely on the pill to safely terminate pregnancies. It would also weaken the FDA’s authority to approve drugs and hinder drug development by creating regulatory uncertainty in the marketplace.
“If FDA’s long-standing drug approvals were so easily enforced, even decades after they were issued, pharmaceutical companies could not confidently rely on FDA approval decisions to develop the pharmaceutical drug infrastructure that Americans rely on to treat a variety of health conditions.” states”, Lawyers from the Biden administration write.
Two separate lawsuits also seek to overturn state restrictions on mifepristone, arguing that they run afoul of FDA regulations.
GenBioPro, another company that makes the pill, is suing to overturn West Virginia’s ban on those grounds. A doctor in North Carolina has also filed a lawsuit to remove restrictions on mifepristone in that state.
Republican attorneys general in 20 states also recently warned CVS and Walgreens not to mail the abortion pills to their states, indicating they would take legal action.
CVS and Walgreensthe two largest drugstore chains in the country are in the process of obtaining certification to dispense 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.