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 August 19, 2023

Biden White House Regrets Federal Court Ruling Blocking FDA's Loosening of Abortion Pill Restrictions

Joe Biden White House press secretary Karine Jean-Pierre issued a statement this week lamenting a federal court ruling that could prevent the U.S. Food and Drug Administration (FDA) from loosening restrictions on mifepristone, the first drug in a two-drug chemical abortion regimen.

Breitbart News reported on the update by the White House, outlining the administration's opinion on the change.

Jean-Pierre asserted|Wednesday: "We strongly disagree with today’s ruling from the Fifth Circuit Court of Appeals in Alliance for Hippocratic Medicine v. FDA, which undermines FDA’s scientific, independent judgment and reimposes onerous restrictions on access to safe and effective medication abortion."

A three-judge panel of the conservative Fifth Circuit Court of Appeals ruled that the FDA's 2016 decision to allow the abortion pill to be taken later in pregnancy is unconstitutional.

The court reached the same conclusion regarding the FDA's 2021 rule change, which permitted the abortion pill to be dispatched directly to patients and authorized medical professionals other than physicians to prescribe mifepristone.

“In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it,” reads the panel opinion, penned by Judge Jennifer Walker Elrod.

The opinion went on:

It failed to consider the cumulative effect of removing several important safeguards at the same time. It failed to consider whether those ‘major’ and ‘interrelated’ changes might alter the risk profile, such that the agency should continue to mandate reporting of non-fatal adverse events.

And it failed to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person.

Despite the court's ruling against the government and the drug manufacturer, mifepristone will continue to be available under extant regulations for the time being as the litigation continues.

In anticipation of a petition for the Supreme Court to hear the case, the Supreme Court has temporarily halted any appeals court decisions this spring. If the Supreme Court does not accept the case, the order of the Fifth Circuit will be implemented.

“Due to the Supreme Court’s stay, mifepristone remains broadly available for now,” the White House statement continued:

But if the Fifth Circuit’s ruling stands, it will significantly roll back the ability for women in every state to get the health care they need, and undermine FDA’s scientific, evidence-based process for approving safe and effective medications that patients rely on.

Jean-Pierre added that the lawsuit "poses an unprecedented threat to the FDA's authority to review, approve, and set evidence-based requirements for a wide range of safe and effective drugs" and that the Department of Justice (DOJ) is seeking a Supreme Court review of the Fifth Circuit's decision.

Jean-Pierre added that regardless, President Joe Biden and Vice President Kamala Harris will persist in their efforts to defend the termination of pregnancies.

“As our fight continues in the courts, President Biden and Vice President Harris remain firmly committed to defending reproductive health care, and the Administration will continue to stand by FDA’s independent approval of mifepristone as safe and effective,” she said.

“In the face of these unprecedented attacks on women’s health, we will continue to fight for women’s freedom to make decisions about their own bodies.”

Written By:
Charlotte Tyler

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