In an unprecedented legal decision, a federal judge Friday halted FDA approval on mifepristone, a widely-used abortion medication. The approval had been in place for two decades.
U.S. District Judge Matthew Kacsmaryk, in a 67-page opinion, ruled that the FDA was in violation of federal regulations that allow accelerated approval of some medications.
He placed a seven-day hold on his decision to allow for an appeal by the Biden administration in the U.S. 5th Circuit Court of Appeals, which is expected.
The injunction did not withdraw or suspend mifepristone’s FDA approval, a move which would have likely halted access to the drug even in states where abortion remains legal.
In the immediate wake of the Kacsmaryk ruling, a Washington state judge ruled in a separate case involving the drug and issued a decision that lines up in direct competition with the Kacsmaryk decision.
The result will likely be a showdown over the medication at the U.S. Supreme Court.
Mifepristone was approved in 2000 and has been widely used for the past 23 years. Its usage was challenged in November by a group of medical associations suing to revoke the drug’s approval.
The doctors argue that the drug’s accelerated approval was under a stipulation that allows for treatment of “serious or life-threatening illnesses,” obviously arguing that mifepristone does not fit that description.
“The [FDA] must protect the health, safety, and welfare of all Americans by rejecting or limiting the use of dangerous drugs. But the FDA failed America's women and girls when it approved chemical abortion drugs for use in the United States,” the organizations argued in court. “And it has repeatedly failed them by removing even the most basic precautionary requirements associated with their use.”
“Removing access to mifepristone would cause worse health outcomes for patients who rely on the availability of mifepristone to safely and effectively terminate their pregnancies,” the FDA argued in rebuttal, adding that the “sudden absence” of medication abortion would likely cause “real and significant harms” to patients choosing to take abortion pills due to medical necessity, for privacy or to avoid further trauma.
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