A federal judge in Texas has extended until Feb. 24 the deadline in a lawsuit seeking 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 lay out its opposition to the attempt to pull the medication from the U.S. market. The anti-abortion physicians who originally filed the lawsuit then have until Feb. 24 to reply.
“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 more than two-decade-old approval of mifepristone.
Used in combination with misoprostol, mifepristone is the most common method to terminate a pregnancy in 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 to whether drugs are safe 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-Choice America, in an analysis 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 new drugs that benefit patients with serious or life-threatening illnesses more than what is otherwise available on the market.
The FDA, in its response, called the lawsuit “extraordinary and unprecedented.” The agency’s lawyers said they could 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…
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