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Supreme Court blocks lower court’s restrictions on abortion pill

Ruling leaves drug on the market during litigation

WASHINGTON — The U.S. Supreme Court said April 21 it would block a lower court’s restrictions on an abortion pill, leaving the drug on the market while litigation over the drug proceeds.

The Supreme Court froze a lower court’s ruling to stay the U.S. Food and Drug Administration’s approval of the drug. The Justice Department and Danco Laboratories, the pharmaceutical company behind the abortion pill mifepristone, previously asked the U.S. Supreme Court to intervene in the case after an appeals court allowed portions of the ruling by U.S. District Judge Matthew Kacsmaryk in Texas to take effect.

The order was an apparent 7-2 vote, with Justices Clarence Thomas and Samuel Alito publicly dissenting.

Erik Baptist, senior counsel for Alliance Defending Freedom, one of the groups challenging the FDA’s approval of mifepristone, said in a statement that “As is common practice, the Supreme Court has decided to maintain the status quo that existed prior to our lawsuit while our challenge to the FDA’s illegal approval of chemical abortion drugs and its removal of critical safeguards for those drugs moves forward.”

A coalition of pro-life opponents of mifepristone, the first of two drugs used in a medication or chemical abortion, filed suit in an effort to revoke the FDA’s approval of the drug, arguing the government violated its own safety standards when it first approved the drug in 2000. However, proponents argued mifepristone poses statistically little risk to women using it for abortion early in pregnancy and claim the drug is being singled out for political reasons.

A federal appeals court on April 12 blocked portions of Kacsmaryk’s ruling suspending the FDA’s approval of mifepristone, ruling that the drug can remain on the market but under more strict regulations while amid a legal challenge to that approval.

A three-judge panel of the 5th U.S. Circuit Court of Appeals agreed April 12 to temporarily block Kacsmaryk’s Good Friday ruling that suspended the FDA’s approval of mifepristone.

However, the appeals court, in its 2-1 decision, also permitted other portions of that ruling to take effect, rolling back FDA rules revised in 2016 and 2021 on a drug the agency originally approved in 2000. Those rules permitted mifepristone’s usage up to 10 weeks of pregnancy rather than the original seven weeks and permitted its distribution by mail.

Separate state lawsuits may also impact whether the drug remains on the market as well, as Washington state seeks to block the Texas ruling. GenBioPro has also sued West Virginia over its ban on mifepristone, arguing it violates the commerce clause of the Constitution.

From the Archive Module

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