A Louisiana-based federal appeals court could decide as soon as Wednesday the availability of the nation’s most used medication abortion drug, as members of Congress from both parties weighed in on a lower court ruling that would stop the manufacture and distribution of the drug this Saturday.
The U.S. Court of Appeals for the 5th Circuit has until the end of the week to decide whether to halt the ruling from Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas that would suspend the Food and Drug Administration’s 2000 approval of mifepristone.
The Biden administration asked for a ruling by Thursday so that it had time to ask the Supreme Court to intervene if needed, and the government filed its final brief in the emergency application Wednesday afternoon.
A group of 69 Republican members of Congress filed a brief at the 5th Circuit that defended Kacsmaryk’s decision, arguing that the FDA violated safeguards Congress placed on the drug approval process with mifepristone and ignored Congress’ decision to make mailing abortion drugs illegal.
“The FDA’s lawless actions ultimately endanger women and girls seeking chemical abortions,” the Republican lawmakers’ brief states.
Republican lawmakers generally have not touted the ruling, while Democrats have been outspoken about the potential fallout and have been strategizing how to respond to the ruling ahead of Saturday.
The House Pro-Choice Caucus held an emergency meeting Monday to discuss next steps, and the White House plans to hold an interagency meeting Wednesday afternoon on the case and how to protect reproductive health patient privacy.
A group of 240 Democratic members of Congress, in a brief filed at the appeals court, asked the judges to stop Kacsmaryk’s “aberrant decision” that threatens access to abortion care, particularly after last year’s Supreme Court decision in Dobbs v. Jackson Women’s Health Organization that overturned the constitutional right to an abortion.
“Just as Dobbs upended abortion access and led to chaos following the decision, eliminating access to mifepristone will further narrow options for care,” the Democrats’ brief stated.
The lawmakers’ brief argued that the Government Accountability Office has reviewed the FDA’s process for mifepristone multiple times and found it was consistent with other drug approvals done by the agency.
“The consequences of the district court’s remedy could extend far beyond mifepristone, for it undermines the science-based, expert-driven process that Congress designed for determining whether drugs are safe and effective,” the brief stated.
The Democratic lawmakers also argued that the lower court decision could have a significant impact on Black maternal health, given the increasingly disproportionate rates of maternal mortality and morbidity among Black women and in states with tighter abortion restrictions.
Joe Manchin III of West Virginia is the only Senate Democrat who did not join the brief. Twenty-three House Democrats did not join.
The Alliance Defending Freedom, the group representing physician groups challenging the drug approval, defended Kacsmaryk’s decision and argued for the drug to be taken off the market by the end of the week.
In a brief to the 5th Circuit, ADF argued that the FDA violated the law to approve mifepristone and the lower court’s order should remain in place.
“That court’s order paints an alarming picture of decades-long agency lawlessness — all to the detriment of the women and girls FDA is charged to protect,” the brief said.
Prominent case
Democrats have signaled they will make the court case a prominent issue in Congress when both chambers return from their recess later this month.
House Energy and Commerce Democrats sent a letter Wednesday to committee Chair Cathy McMorris Rodgers, R-Wash., and Health Subcommittee Chair Brett Guthrie, R-Ky., calling for a hearing on the Texas court’s unprecedented decision over an FDA-approved drug and the effect on the review process.
“Given the implications of this decision, we believe it is important for the Committee to hear from experts about how the outcome of this case attempts to undermine the drug approval process, restricts access to an FDA-approved medication, and places ideology, politics, and judicial activism above science,” the members wrote.
Senate Judiciary Chair Sen. Richard J. Durbin, D-Ill., announced the panel would hold a hearing on the aftermath of last year’s Supreme Court decision overturning the constitutional right to an abortion in Dobbs v. Jackson Women’s Health Organization.
In a statement accompanying the announcement, Durbin said he “will keep fighting to enshrine into law a woman’s right to make her own reproductive choices. We cannot let our children inherit a nation that is less free and more dangerous than the one their parents grew up in.”
The Senate is also poised to vote on an abortion rights bill.
Kacsmaryk issued the decision suspending the FDA approval of mifepristone Friday but stayed the effect of his decision for a week to allow for appeals.
The Biden administration asked the 5th Circuit to pause Kacsmaryk’s ruling in a filing Monday that said the order would “thwart FDA’s scientific judgment and severely harm women, particularly those for whom mifepristone is a medical or practical necessity.”
Experts said the case will likely soon head to the Supreme Court regardless of how the 5th Circuit rules, especially because of an order from a Washington federal judge last week that mandated the FDA preserve the status quo for 17 states and the District of Columbia.
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