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Justice Department asks Supreme Court to intervene in abortion drug ruling
By Ariane de Vogue, Tierney Sneed and Devan Cole, CNN Updated 11:24 AM EDT, Fri April 14, 2023
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The Justice Department asked the Supreme Court Friday to intervene in an emergency dispute over a Texas judge's medication abortion drug ruling, requesting that the court step in now rather than wait for an appeal to formally play out at the federal appellate level.
The case is the most important abortion-related dispute to reach the high court since the justices overturned Roe v. Wade last term. It centers on the scope of the US Food and Drug Administration's authority to regulate a drug that is used in the majority of abortions today in states that still allow the procedure.
Solicitor General Elizabeth Prelogar said in the filing that it "concerns unprecedented lower court orders countermanding FDA's scientific judgment and unleashing regulatory chaos by suspending the existing FDA-approved conditions of use for mifepristone."
She said that if the ruling were allowed to stand it would "inflict grave harm on women, the medical system, the agency, and the public."
Danco, a manufacturer of the drug, also asked the justices to step in on an emergency basis before Friday, with an attorney for the company saying in its filing that leaving the lower court opinion in play will "irreparably harm Danco, which will be unable to both conduct its business nationwide and comply with its legal obligations under the FDCA nationwide."
"The lack of emergency relief from this Court will also harm women, the healthcare system, the pharmaceutical industry, States' sovereignty interests, and the separation-of-powers," the attonrey, Jessica L. Ellsworth, told the justices.
The clock is ticking. If the Supreme Court does not step in, the district court's ruling, as amended by a subsequent appeals court opinion, will go into effect at midnight CT, and access to the drug, Mifepristone, will be restricted while the appeals process plays out.
Both the government and Danco are asking the court to freeze the lower court opinion, or alternatively, agree to take up the case themselves and hear arguments before the summer recess, a very expedited time frame.
The controversy began when US District Court Judge Matthew Kacsmaryk issued a broad ruling that blocks the FDA's 2000 approval of the drug, as well as changes the FDA made in subsequent years to make the drug more accessible.
Late Wednesday, the 5th US Circuit Court of Appeals froze part of the ruling. The court said the drug, that was approved in 2000, could stay on the market, but agreed with Kacsmaryk that access could be limited.
The appeals court ordered a return to the stricter, pre-2016 FDA regime around the drug, which prevents mailing the pill to patients who obtained it through telehealth, or virtual visits with their providers rather than traveling to a clinic or hospital to obtain the drug in person.
