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Judge Halts FDA Approval Of Abortion Pill As The Biden Administration Vows To Fight

A Texas judge halted the approval of the abortion pill as the Biden Administration plan to appeal the decision in post-Roe

A U.S. judge in Texas has suspended the government’s decades-old approval of the abortion pill mifepristone, which terminates a pregnancy within the first 10 weeks.

On Friday, Judge Matthew Kacsmaryk of the U.S. Northern District of Texas, who was appointed to the bench by former President Donald Trump, ruled that the Food and Drug Administration (FDA) had ignored the risks in approving the drug. Kacsmaryk also noted that his ruling would not take effect for one week to give U.S. President Joe Biden’s administration seven days to appeal to the 5th U.S. Circuit Court of Appeals. 

A pro-abortion activist displays abortion pills as she counter-protests during an anti-abortion demonstration on March 25, 2023, in New York City. A Texas judge halted the approval for an FDA abortion pill. KENA BETANCUR/BENZINGA

“The Court does not second-guess FDA’s decision-making lightly,” he wrote in his ruling. “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.”

Soon after, however, Judge Thomas Owen Rice of the U.S. District for the Eastern District of Washington issued a seemingly conflicting injunction that prevented federal regulators from altering access to the same abortion drug, Reuters reported. 

According to Reuters, four anti-abortion groups headed by the recently formed Alliance for Hippocratic Medicine and four anti-abortion doctors sued the FDA in November, arguing the FDA had followed an improper process to approve mifepristone in 2000. The petitioners also asserted that the agency did not adequately consider the drug’s safety when used by girls under 18 to terminate a pregnancy.

The Biden administration has vowed to fight the abortion pill ruling, according to Bloomberg. 

“If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks,” Biden said. 

“It is the next big step toward the national abortion ban that Republican elected officials have vowed to make law in America,” he added. 

Vice President Kamala Harris also chimed in, saying that the Texas decision threatens women’s rights nationwide and ripples beyond abortion rights. 

“This decision undermines the FDA’s ability to approve safe and effective medication,” she said in a separate statement. “Our Administration will continue to fight to protect reproductive freedom and the ability of all Americans to make health care decisions with their doctors free from political interference.” 

Drug companies slammed the judge’s decision on the abortion pill calling it an undermining of the FDA’s authority. 

“If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone,” the executives said in a written statement.

BIO, a biotech lobbying group, also criticized the decision as an “attack on science.”

Produced in association with Benzinga

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