All FDA-approved drugs could be at risk, FDA officials warn.
was allowed to stand, suggesting all federally-approved medications—including birth control and vaccines—could be under attack., a Trump-appointed federal judge in Texas, temporarily rescinded the Food and Drug Administration’s approval for mifepristone, one of two drugs used in medication abortion procedures. According to legal experts, it marked the first time a judge has ever overruled an FDA approval.
“The implications of this case go far beyond [abortion],”added Jennifer Dalven, director of the ACLU Reproductive Freedom Project. “If the courts allow this, it will radically change the process for approving new drugs and chill innovation.” She noted that the approval of mifepristone had been reviewed multiple times over the last 20 years, including a 2016 review by the Government Accountability Office that found there was “no political intervention in that process.” Further reviews by the FDA actually resulted in a loosening of restrictions around the dispensing of the drug, after further studies and years of use proved its safety and effectiveness.
Kacsmaryk’s ruling is a preliminary injunction, meaning it holds only until he hears the full case and issues a final ruling. Kacsmaryk gave until Friday for the ruling to take effect or be overturned, and the Biden administration has already filed an appeal of the ruling to the Fifth Circuit Court of Appeals. If the Fifth Circuit does not overturn the injunction, the administration will likely appeal the case up to the Supreme Court.
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