A federal judge in Texas ruled to withdraw the Food and Drug Administration's approval of the abortion drug mifepristone, potentially making medication abortion less accessible nationwide
The future of medication abortion, which accounts for more than half of abortions in the U.S., is in limbo after a federal judge ordered the Food and Drug Administration to withdraw its approval of the drug mifepristone, also known as RU-486, which is used in medication abortions. If the ruling is upheld, such abortions will still be possible using another drug regimen.
What does the ruling challenging mifepristone’s approval address? Kacsmaryk’s ruling came in response to a lawsuit by the Alliance for Hippocratic Medicine, a group of antiabortion organizations and doctors who claimed that the FDA ignored reports that patients had been harmed by mifepristone and that it did not follow proper procedures in approving the drug more than 20 years ago.
The third complaint could have the biggest impact on drug policy. The plaintiffs say that the FDA’s approval and its delayed response to complaints brought by antiabortion advocates in 2002 were “arbitrary and capricious” and that evidence of mifepristone’s safety and efficacy were insufficient. The FDA issued an interim response in 2003 and a final response in 2016, ultimately denying the complaints based on extensive evidence of the drug’s safety.
“The concern is really quite well founded,” says Patricia Zettler, a health law expert at the Ohio State University. Courts have tried to ban drugs in the past: in 2014 a judge in Massachusetts tried to ban the sale of an addictive painkiller called Zohydro. That decision was overruled by a federal judge on the grounds that the FDA’s federal authority takes precedence over state law. But Zettler says no federal judge has ever tried to overturn the FDA approval itself.
“We have over 20 years of data showing that the use of mifepristone is incredibly safe for medical abortion in the United States,” says Kari White, director of the Texas Policy Evaluation Project at the University of Texas at Austin. The lawsuit, she says, “seems to be a means by which those who are opposed to abortion are trying to limit people’s ability to obtain abortion care even in states where abortion remains legal.
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