The judge extended the period for considering a claim for the export of drugs from the United States
A federal judge in Texas has extended until Feb. 24 the deadline for a lawsuit seeking to overturn the Food and Drug Administration’s approval of an abortion pill.
Judge Matthew Kachmarik on Thursday ordered one of the pill companies, Danco Laboratories, to state its opposition to the attempt to withdraw the drug from the US market. Anti-abortion doctors who originally filed the lawsuit have until February 24 to respond.
“The briefing on this matter will be closed in the absence of any ‘exceptional or extraordinary circumstances’,” Kaczmarik wrote.
The Hippocratic Alliance for Medicine, a coalition of doctors opposed to abortion, sued the FDA in November over a more than twenty-year-old approval of mifepristone.
Mifepristone, used in combination with misoprostol, is the most common method of abortion in the US, accounting for about half of all abortions.
Abortion Rights Group NARAL Pro-Choice America, in an analysis released on Fridaystated that 40 million women would lose access to abortion pills if the Hippocratic Medicine Alliance were successful and mifepristone was effectively banned.
The alliance argued that the FDA abused its authority by approving mifepristone in 2000 through a fast track process for new drugs that benefit patients with serious or life-threatening conditions more than those available on the market.
The FDA, in its response, called the lawsuit “extraordinary and unprecedented.” The agency’s lawyers said they could not find a single previous example of a court reassessing the FDA’s decision to approve a drug.
Agency lawyers wrote that the FDA has approved mifepristone as a safe and effective method of terminating early pregnancy based on extensive scientific evidence. Lawyers argue that years of experience among thousands of women has confirmed that the drug regimen is safer than surgical abortion or childbirth.
The FDA has warned that the removal of mifepristone from the US market will lead to a deterioration in the health of patients who rely on pills to safely terminate their pregnancies. It would also weaken the FDA’s drug approval authority and hinder drug development by creating regulatory uncertainty in the marketplace.
“If long-standing FDA drug approvals could be so easily obtained, even decades after they were issued, pharmaceutical companies would not be able to confidently rely on FDA approval decisions to develop the pharmaceutical infrastructure that Americans depend on to treat a variety of diseases.” the study says. Biden administration lawyers wrote about this.
Two separate lawsuits also seek to remove state restrictions on mifepristone, alleging that they are contrary to FDA rules.
GenBioPro, another company that makes the pill, is suing to overturn West Virginia’s ban on those grounds. A doctor in North Carolina also sued to overturn restrictions on the use of mifepristone in that state.
Republican attorneys general in 20 states also recently warned CVS and Walgreens against mailing abortion pills in their states, indicating they would sue.
CVS And walgreensthe country’s two largest drugstore chains are in the process of obtaining certification to dispense mifepristone in states where it is legal.
The FDA recently changed its rules to allow retail pharmacies to dispense prescription drugs as long as they are certified.