A federal judge in Texas has prolonged until Feb. 24 the deadline in a lawsuit looking for to overturn the Food and Drug Administration’s approval of the abortion pill.
Judge Matthew Kacsmaryk on Thursday ordered considered one of the businesses that makes the pill, Danco Laboratories, to put out its opposition to the try to pull the medication from the U.S. market. The anti-abortion physicians who originally filed the lawsuit then have until Feb. 24 to answer.
“Briefing will then be closed on the matter, absent any ‘exceptional or extraordinary circumstance,'” Kacsmaryk wrote.
The Alliance for Hippocratic Medicine, a coalition of physicians who oppose abortion, sued the FDA in November over its greater than two-decade-old approval of mifepristone.
Used together with misoprostol, mifepristone is probably the most common method to terminate a pregnancy within the U.S., accounting for about half of all abortions.
“Forcing FDA to withdraw a longstanding approval would seismically disrupt the agency’s governing authority as as to if drugs are protected and effective, and would cause Danco direct and immediate harm by shuttering its business,” the attorneys for the abortion pill maker Danco Laboratories told the court on Friday.
The abortion rights group NARAL Pro-Selection America, in an evaluation published Friday, said 40 million women would lose access to the abortion pill if the Alliance for Hippocratic Medicine succeeds and mifepristone is effectively banned.
The alliance argued that the FDA abused its authority by approving mifepristone in 2000 through an accelerated process for brand new drugs that profit patients with serious or life-threatening illnesses greater than what’s otherwise available available on the market.
The FDA, in its response, called the lawsuit “extraordinary and unprecedented.” The agency’s lawyers said they may not find any previous example of a court second-guessing an FDA decision to approve a drug.
The agency also said mifepristone was not approved under an accelerated pathway. It took greater than 4 years from the filing of the initial application until the pill was approved.
The FDA approved mifepristone as a protected and effective method to terminate an early pregnancy based on extensive scientific evidence, the agency’s lawyers wrote. Many years of experience amongst hundreds of ladies have confirmed that the drug regimen is safer than surgical abortion or childbirth, the lawyers argued.
The FDA warned that pulling mifepristone from the U.S. market would end in worse health outcomes for patients who depend on the pill to securely end pregnancies. It could also weaken the FDA’s drug approval powers and hinder development by creating regulatory uncertainty within the marketplace.
“If longstanding FDA drug approvals were so easily enjoined, even many years after being issued, pharmaceutical firms could be unable to confidently depend on FDA approval decisions to develop the pharmaceutical-drug infrastructure that Americans depend upon to treat a wide range of health conditions,” the Biden administration lawyers wrote.
Two separate lawsuits are also looking for to overturn state restrictions on mifepristone, arguing that they conflict with FDA regulations.
GenBioPro, one other company that makes the pill, is suing to overturn West Virginia’s ban on these grounds. A physician in North Carolina has also sued to toss out restrictions on mifepristone in that state.
Republican attorneys general in 20 states also recently warned CVS and Walgreens against mailing the abortion pill of their states, indicating that they’d take legal motion.
CVS and Walgreens, the nation’s two largest drugstore chains, are within the means of getting certified to dispense mifepristone in states where it’s legal to achieve this.
The FDA recently modified its regulations to permit retail pharmacies to dispense the prescription medication so long as they’re certified.