Appeals court can rule at any time in dispute over suspending FDA approval of medication abortion drug

By Tierney Sneed, CNN

The Justice Department and a manufacturer of abortion pills have submitted the final round of court briefs in the emergency dispute over whether an appeals court should freeze a judge’s ruling that would suspend the Food and Drug Administration’s approval of medication abortion drugs.

Now that the filings have been submitted, the US 5th Circuit Court of Appeals Court could rule at any time on whether to put a hold on the order from US District Judge Matthew Kacsmaryk.

Kacsmaryk on Friday night said he was halting the FDA’s approval of the drug mifepristone but that he was delaying the order by seven days to give the pill’s defenders time to appeal the case. The Justice Department has asked the appeals court to act by 12 p.m. CT Thursday on its request that Kacsmaryk’s ruling be paused, to give the government time to seek a Supreme Court intervention if need be. The 5th Circuit is not obligated to meet that deadline.

The Justice Department wrote in its new filing that Kacsmaryk purported “to be acting in a restrained manner … but there is nothing modest about upending the decades-long status quo by blocking access nationwide to a safe and effective drug.”

“Effectively requiring Danco Laboratories and GenBioPro to cease distribution of mifepristone after more than two decades would upend the status quo, severely harming women, healthcare systems, and the public,” the Justice Department said, referring to the two US manufacturers of mifepristone.

The Justice Department filing pushed back on the assertions by the challengers, made in their filing overnight in the emergency dispute, that the 5th Circuit did not have the authority to hear the appeal of Kacsmaryk’s ruling. The Justice Department also called out Kacsmaryk and the challengers for relying on anonymous blog posts to claim mifepristone is unsafe.

Danco Labroratories, which intervened in the case to defend mifepristone’s approval, wrote in its new filing with the appeals court that if the ruling is not frozen, “women across the nation will face serious, unnecessary health risks from the elimination of access to a drug FDA has repeatedly deemed safe and effective and that is the standard of care.”

In an overnight filing, the anti-abortion doctors who sued to ban medication abortion drugs told a federal appeals court that it should leave in place the ruling that will halt the drug’s FDA approval.

The anti-abortion doctors defended Kacsmaryk’s ruling called it a “meticulously considered” ruling that “paints an alarming picture of decades-long agency lawlessness — all to the detriment of the women and girls FDA is charged to protect.”

Mifepristone has been approved by the FDA for terminating pregnancies for nearly 23 years. Leading medical associations have rebuked the claims by the approval’s legal challengers and by the judge that the drug is unsafe.

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