(DCWatchdog.com) – The US Department of Justice has immediately appealed a federal judge’s ruling that blocked the FDA’s 2000 approval of the abortion-inducing drug mifepristone.
The DOJ move came after last Friday, Judge Matthew Kacsmaryk of the US District Court for the Northern District of Texas suspended the Food and Drug Administration’s approval of the abortion pill.
Kacsmaryk’s order, which is in a lawsuit brought before him by anti-abortion activists, has thus practically ended mifepristone sales for the duration of the case.
Meanwhile, hours later, also on Friday, a competing ruling was issued by Judge Thomas Rice of the Eastern District of Washington state.
According to Rice, the FDA must maintain mifepristone’s availability in 17 Democratic-led states and the District of Columbia.
“The dueling orders make it likely that higher courts will consider both cases in an expedited fashion,” The National Review commented in a report.
On Monday, the US Justice Department challenged the standing and the merits of the Texas-based judge’s preliminary injunction.
“Plaintiffs lack standing to challenge FDA’s approval of a drug they neither take nor prescribe. The court also erred by holding that plaintiffs’ claims are timely,” stated the DOJ court filing as the Fifth Circuit Court of Appeals.
“FDA’s approval of mifepristone and subsequent modifications of the REMS [risk evaluation and mitigation strategy] were wholly reasonable,” the filing said further.
It insisted that mifepristone was safe, which had been proven by all the available evidence.
The lawsuit before Judge Kacsmaryk was brought by four anti-abortion doctors and the Alliance for Hippocratic Medicine, an organization of pro-life medical groups.
They argued that the FDA had no authority to approve the chemical abortion regime involving mifepristone, it failed to explore its safety correctly, and “stonewalled” doctors who tried to challenge it.
The Biden administration’s Justice Department has attacked each of the plaintiff’s main arguments, which Kacsmaryk has supported.
“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,” the judge wrote.
The report notes that the FDA at first approved the chemical abortion regimen based on a section of the federal code known as Subpart H. Subpart H permits expedited approval of drugs that can be used to treat “serious or life-threatening illnesses” or that provide a “meaningful therapeutic advantage over existing treatment.”
The DOJ’s appeal has disputed the plaintiffs’ insistence that pregnancy is not an illness, so the FDA “had no business” approving abortion drugs under Subpart H. According to the Biden administration, Subpart H was invoked correctly.
“FDA found that pregnancy ‘can be a serious medical condition in some women,’ and mifepristone avoided a surgical procedure for 92% of patients,” the DOJ court filing reads.
The Biden administration argues further that plaintiffs have no legal right to challenge the FDA’s 2000 decision since its statute of limitations has expired. Then, in 2016, when the FDA changed the abortion pill’s conditions of use, the state was not reopened.
If the DOJ appeal fails, it is expected to take the case to the US Supreme Court.
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