Federal Judge Orders FDA To Stop Approval Of Controversial Drug

Last week, a Texas federal judge halted the FDA’s approval of the abortion pill mifepristone, prompting the Biden administration to immediately file a notice of appeal, CBS News reported.

In his 67-page decision, US District Judge Matthew Kacsmaryk said the FDA violated a federal rule allowing for accelerated approval for certain drugs and that subsequent actions by the FDA were unlawful.

While the pro-life medical associations that brought the lawsuit had asked that the court withdraw or suspend the FDA’s approval of mifepristone, Kaczmaryk’s injunction stopped short of doing so.

Judge Kaczmaryk put a 7-day hold on his decision to allow for the administration to appeal the ruling to the 5th Circuit Court of Appeals. And on Friday night, the administration filed its notice to appeal.

In a statement Friday night, President Biden condemned the ruling, accusing the judge of substituting his judgment for the FDA’s. Biden claimed that under Judge Kacsmaryk’s ruling, no FDA-approved prescription would be safe from “political” and “ideological attacks.”

Biden described the ruling as “another unprecedented step” to take away “basic freedoms” while putting women’s health at risk.

Attorney General Merrick Garland said in a statement last Friday evening that the Department of Justice “strongly disagrees” with Kaczmaryk’s decision. He confirmed that the DOJ would appeal the decision and request a “stay pending appeal.”

Garland decried the decision as overturning “the FDA’s expert judgment” that the abortion drug is “safe and effective.”

Mifepristone was approved by the FDA over 20 years ago.

When used with the drug misoprostol, mifepristone is used as an abortifacient when taken within the first ten weeks of gestation.

The drug blocks the production of progesterone, a hormone necessary during pregnancy. Without the production of progesterone, the uterine lining stops thickening and begins to break down, causing the embryo to detach. The second drug, misoprostol then causes the uterus to contract and the cervix to dilate, which expels the embryo.

Abortion drugs account for more than half of US abortions each year.