Biden administration asks Supreme Court to take up major abortion pill case

The Biden administration asked the Supreme Court on Friday to review an opinion of a lower court that allowed the abortion pill but restricted its distribution.

In a cert. petition, the Justice Department claimed that the loss of access mifepristone would be “damaging” for women and healthcare professionals around the nation. The government referred to mifepristone as the “best method to terminate an early pregnancy,” and cited the Food and Drug Administration’s prior determination that the drug was safe and effective.

The Justice Department’s lawyers wrote that the lower court decisions would force FDA to go back to the pre-2016 regulatory system that imposes distribution restrictions that FDA found to be unjustified and unnecessary.

The petition was filed just hours after Danco Laboratories, a manufacturer of abortion pills, had also asked the Supreme Court to review a lower court decision.

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A three-judge panel of the 5th U.S. The New Orleans Circuit Court of Appeals reversed the FDA’s deregulation of abortion pills. The decision ended Mifepristone’s availability by mail and required it to be administered in the presence of a doctor. It also stated that Mifepristone can only used up until the seventh week of pregnancy.

In her ruling, Judge Jennifer Walker Elrod stated that the FDA “failed to address several concerns regarding the safety of the drug for women who use it.”

The Justice Department called the decision “unprecedented”, and said it contradicted FDA expert opinion.

The Supreme Court issued an injunction to temporarily keep the Biden administration’s deregulated regulations in place until the court case is resolved. Mifepristone is still available in all states that allow abortions under FDA-approved conditions.

Mifepristone is also known as Mifeprex. It is a pill that, when taken in conjunction with misoprostol, deprives the unborn child of the hormones necessary to survive. Then, the cramps and contractions are used to expel the dead baby from the mother’s body.

Danco claims that more than 5,000,000 women in the United States have used Mifeprex since 2000, when the FDA approved it for use. The drug is 97% efficient in terminating an early pregnancy. However, the company claims that 3% of women will need surgical intervention due to ongoing pregnancy, heavy bleeds, incomplete expulsion, or other reasons, such as patient requests.

Danco stated in a press release that “the FDA actions in question were well supported by extensive data on safety and efficacy from clinical trials as well as decades of real-world experiences with millions of patients.” “The FDA approved changes for 2016 and 2021, which have increased the availability and use Mifeprex (r), resulting in important benefits to individuals and public health.”

Alliance Defending Freedom (ADF), which brought the Texas lawsuit to stop the FDA from approving Mifepristone in the first place, said that the 5th Circuit’s decision was a victory for women’s healthcare.

The 5th Circuit rightfully required the FDA do its job and restore vital safeguards for women and girl, including ending illegal abortions by mail order, said ADF Senior Attorney Erin Hawley. Vice president of the ADF Center for Life and Regulatory Practice. The FDA will be held accountable for the harm it has done to the health and rule of law of many women and girls by removing all meaningful safeguards from the chemical abortifacient drug regimen.