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Saturday, May 18, 2024

Approval of Abortion Pill Mifepristone by F.D.A. Invalidated by Judge

A federal judge in Texas has issued a preliminary ruling that could make it more difficult for patients to obtain abortions even in states where abortion is legal, not just in those trying to restrict it. The ruling invalidates the Food and Drug Administration’s (FDA) 23-year approval of the abortion pill mifepristone.

Since Judge Matthew J. Kacsmaryk postponed his own decision for seven days to provide the F.D.A. time to petition an appeals court to intervene, the drug will remain accessible at least in the near term.

A court in Washington state delivered a finding in a separate case less than an hour after court Kacsmaryk’s decision, which directly contradicted the Texas decision by directing the F.D.A. to make no modifications to the availability of mifepristone in the 18 states that brought that complaint.

In a legal confrontation likely to reach the Supreme Court, two federal courts have granted duelling preliminary injunctions before hearing the entire cases.

President Biden has said that the federal government would challenge the Texas decision. “This is not something that only affects women in Texas,” he added. If upheld, it would make it impossible for women in any state where abortion is permitted to get the medicine.

The first judgement in the case by Judge Kacsmaryk, a Trump nominee who has written negatively about Roe v. Wade, might be the most significant abortion decision since the Supreme Court overruled Roe v. Wade last June.

To challenge the FDA’s limits on the prescription and distribution of mifepristone, 18 Democratic attorneys general filed action in Washington State. In that case, Judge Thomas O. Rice issued a preliminary injunction barring the FDA from “any action to remove mifepristone from the market or otherwise cause the drug to become less available,” which applied to the states that had sued.

More than half of all abortions in the United States are induced by medication. The complaint claims that the F.D.A. has neglected safety concerns associated with mifepristone since it was authorised in 2000 without conducting a thorough evaluation of the scientific data and failing to follow basic standards.

Defending the manufacturer of Mifeprex, a brand name of mifepristone, Danco Laboratories, which had entered the litigation on the side of the F.D.A., the company’s attorney strongly disagreed with the judge’s characterizations.

Several legal avenues exist that might enable mifepristone producers to keep distributing the medicine and physicians to keep prescribing it to patients, even if the Texas verdict is maintained.

Misoprostol, the second abortion medicine, is used successfully on its own in many countries where mifepristone is less accessible, and some abortion doctors intend to give just misoprostol if legal access to mifepristone is banned. Misoprostol, a medicine licenced for various medical reasons, induces contractions comparable to those seen during a miscarriage; nevertheless, it is thought to be somewhat less successful when used alone than when combined with mifepristone and is more likely to produce side effects including nausea.

In 2002 and 2019, citizen petitions were submitted against the F.D.A.’s actions on mifepristone, and several of the same anti-abortion organisations who brought the Texas litigation also filed these petitions. Both were deemed to be without merit by the board. Furthermore, the F.D.A.’s approval of mifepristone was deemed to be lawful after a review by the Government Accountability Office in 2008.

According to legal experts, this case seems to be the first time a court has acted to force the removal of a medicine from the market against the F.D.A.’s objections, and if the verdict stands, it might have implications for the federal government’s ability to regulate other pharmaceuticals.

If this verdict stands, practically no medication certified by the F.D.A. would be immune from these types of political, ideological assaults,” Biden said in a statement.

Jonathan James
Jonathan James
I serve as a Senior Executive Journalist of The National Era
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