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Uncertain Future For Abortion Pill After Divergent US Court Rulings

by | Wed, Apr 12 2023

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The US Supreme Court may be forced to intervene to decide whether an abortion pill can continue to be readily available to millions of American women following a landmark decision that threatens to upend the entire foundation of US drug regulation.

A federal judge in Texas has suspended the US Food and Drug Administration (FDA)’s approval of the chemical abortion pill mifepristone, but almost at the same time another federal judge in Washington State issued an opposite ruling.

In Texas, Judge Matthew Kacsmaryk, a Trump appointee, issued a stay of the FDA’s 2000 approval of mifepristone, the first drug in the chemical abortion regimen and also known as RU-486, which has been freely used for more than 20 years and is used in the majority of all US abortions.

The Christian Post reports his ruling won’t go into effect for at least seven days after the US Department of Justice confirmed it would challenge the  ruling.

Judge Kacsmaryk wrote in his 67-page opinion: “The Court does not second-guess FDA’s decision-making lightly. 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.”

He added that: “There is also evidence indicating FDA faced significant political pressure to forego its proposed safety precautions to better advance the political objective of increased ‘access’ to chemical abortion — which was the ‘whole idea of mifepristone.’

The judge argued that the FDA abandoning its proposed restrictions “resulted in many deaths and many more severe or life threatening adverse reactions. Due to FDA’s lax reporting requirements, the exact number is not ascertainable.”

The long-anticipated ruling is being praised by pro-life advocates with Katie Glenn from SBA Pro-Life America hailing it as a “win for the health and safety of women and girls.”

“The ruling reaffirms that pregnancy is not an illness and abortion is not health care. Finally, the FDA is being held accountable for its egregious violation of its own rules to fast-track dangerous abortion drugs to market,” she said.

“The abortion drug regimen rubber-stamped by the FDA has proven disastrous for women as well as unborn children, with the FDA’s own data showing women have died. The Biden FDA ignored the science and approved abortion drugs for sale by mail-order, without any in-person doctor visit, which the strong majority of Americans oppose,” Ms. Glenn contended.

Judge Kacsmaryk’s ruling was criticised by abortion supporters who believe it will further hamper access to abortion in the aftermath of last year’s US Supreme Court historic Roe v. Wade decision that the US Constitution doesn’t include a right to abortion.

However they were buoyed by another decision in Washington State where Judge Thomas Rice, an Obama appointee, issued a preliminary injunction prohibiting the FDA from “altering the status quo and rights as it relates to the availability of mifepristone” as 17 states and Washington, D.C., asked the court to prevent the FDA from “reducing mifepristone’s availability.”

The plaintiffs’ case was that it is “fair and equitable for FDA to not act with respect to the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) program until a determination is made on the merits.”

Judge Rice noted in his 31-page opinion that the plaintiffs asserted that:

  1. FDA acknowledges that serious adverse events are ‘exceedingly rare’.
  2. Mifepristone’s associated fatality rate is .00005%, with not a single death ‘casually attributed to mifepristone.’
  3. All the data shows that mifepristone is among the safest drugs in the world, and safer than the vast majority of drugs for which FDA has never attempted to impose a REMS.
  4. There is no reasoned scientific basis for subjecting it to additional burdens that are not applied to other, riskier medications.