The ruling from U.S. District Judge Matthew Kacsmaryk in Amarillo could potentially upend access to medication abortion nationwide. Texas mifepristone MedicationAbortion AbortionIsHealthcare abortionrights
Prevent emergency contraception contains the pregnancy-termination drug mifepristone.
“The Court does not second-guess FDA’s decision-making lightly,” Kacsmaryk wrote in the ruling. “But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.” , and the language in the 67-page ruling, released at 5:30 p.m. Friday, reflects those ties — calling abortion providers “abortionists” and describing the use of mifepristone that prohibits the mailing of anything related to an abortion, which could have much wider effects than this one lawsuit.
“The FDA put women and girls in harm’s way and it’s high time the agency is held accountable for its reckless actions,” he said. “The FDA never had the authority to approve these hazardous drugs and remove important safeguards.”Almost since the FDA approved mifepristone in 2000, anti-abortion groups have been working to reverse that decision.
This lawsuit, filed by the ADF in November, is the latest attempt to move mifepristone off the market. The ADF is representing a group of anti-abortion doctors and medical associations who say they have been harmed by having to treat complications from abortion-inducing medication. “But pregnancy is not an illness, nor do chemical abortion drugs provide a therapeutic benefit over surgical abortion,” their lawsuit reads. “In asserting these transparently false conclusions, the FDA exceeded its regulatory authority to approve the drugs.”
Legal experts and the FDA have identified several crucial issues with the lawsuit, from misstated science, to a long-expired statute of limitations, to a lack of standing.
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