Hundreds of lawmakers have signed onto amicus briefs designed to sway the Fifth Circuit Court of Appeals in its decision on the Food and Drug Administration’s (FDA) approval of mifepristone, the first drug in the abortion pill regimen.
The dueling briefs come after the Supreme Court sent the case back to the Appeals Court in April. It allowed the pill to remain on the market while the case finished making its way through the court system. The Fifth Circuit is currently reviewing Texas judge Matthew Kacsmaryk’s original decision to upend the FDA’s approval.
Democrats’ brief, filed on May 1, included 203 members of the House and 50 senators. It urged the Fifth Circuit to overturn Kacsmaryk’s decision, arguing that the judge had overstepped his authority by overriding the FDA’s assertion of expertise on the abortion pill’s safety.
“For decades, the federal judiciary has respected Congress’s delegation of the drug approval process to FDA’s scientists and experts,” the lawmakers’ brief read. “While courts have, on occasion, held against FDA on issues related to the market exclusivity that is afforded to a drug sponsor by the statute, it is an extraordinary and unprecedented step for the district court to invalidate on substantive grounds—and over FDA’s objection—a longstanding approval for a drug with a history of safe and effective use. This Court should reverse that aberrant decision and order.”
They added that Kacsmaryk’s decision would hinder abortion access as well as “disrupt industry expectations and could chill pharmaceutical research and development.”
Republicans, meanwhile, filed in support of Kacsmaryk’s decision and criticized the FDA for, among other things, not adequately considering the impacts of the abortion pill on minor patients. It also cited the Comstock Act, which prohibits mailing certain items like abortion pills.
“By approving and then deregulating chemical abortion drugs, the FDA failed to follow Congress’ statutorily prescribed drug approval process and subverted Congress’ critical public policy interests in upholding patient welfare,” read the brief, which was filed last week.
It continued, “Moreover, the FDA in 2016 eliminated any requirement that adverse non-fatal medical events resulting from chemical abortion be reported to the FDA, then claimed in its 2021 revision that the absence of reported complications demonstrated that chemical abortion was safe. The FDA’s lawless actions have endangered women and girls seeking chemical abortions, and the Court should affirm the District Court’s ruling.”
From the House, 76 members joined the brief. In total, 18 senators signed on with Pro-Life Caucus Chair Cindy Hyde-Smith (R-Miss.) leading the charge. In April, Republicans filed another brief with even fewer members signing.
Republicans’ brief came as the party faced an internal debate over how far they should go in restricting abortion. At least one Republican – Rep. Nancy Mace (R-S.C.) – went so far as to agree with Rep. Alexandria Ocasio-Cortez (D-N.Y.) in calling on the Biden administration to ignore Kacsmaryk’s decision. Others have bristled at federal abortion bans, suggesting the issue should stay in states’ hands.
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