Cantwell, Congressional Democrats File Amicus Brief Urging Fifth Circuit to Reverse Texas District Court’s Ruling on Mifepristone

Amicus brief follows Supreme Court’s decision to reject lower-court restrictions while lawsuit continues

WASHINGTON, D.C. – Today, U.S. Senator Maria Cantwell (D-WA) joined 252 Members of Congress in submitting an amicus brief to the U.S. Court of Appeals for the Fifth Circuit in the case of Alliance for Hippocratic Medicine v. FDA, urging the Court to reverse the district court’s stay on the FDA’s more than 20-year-old approval of mifepristone. In April, the Supreme Court issued a stay of the lower court ruling that allows mifepristone to remain on the market while the case is under review.

The amicus brief was led by Senators Schumer (D-NY), Murray (D-WA), Sanders (I-VT), Durbin (D-IL), and Blumenthal (D-CT) and Representatives Jeffries (D, NY-08), Clark (D, MA-05), Pallone (D, NJ-06), Nadler (D, NY-12), Lee (D, CA-12), and DeGette (D, CO-01).

The Members argued that the district court’s decision has no basis in law, poses a serious health risk to pregnant women and other individuals by denying patients in every part of the country access to mifepristone—a safe and effective medication widely used in abortion care and miscarriage management for years—and threatens patients’ access to a wide array of other medications by threatening FDA’s drug approval process, which was designed and mandated by Congress. Accordingly, they ask the Fifth Circuit to reverse the district court’s order.

“FDA’s determination that mifepristone is safe and effective is based on a thorough and comprehensive review process prescribed and overseen by the legislative branch,” the Members wrote. “Since mifepristone’s initial approval in 2000, FDA has repeatedly and consistently affirmed that the medication is safe and effective for its approved conditions of use. FDA’s process and conclusions have been validated by both Congress and the Government Accountability Office—and by the lived experience of over 5 million patients who have used the drug in the United States.”

“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 lawmakers continued. “Providers and patients rely on the availability of thousands of FDA-approved drugs to treat or manage a range of medical conditions, including asthma, HIV, infertility, heart disease, diabetes, and more.”

The lawmakers cite reports from doctors and journalists highlighting the increased importance of mifepristone for reproductive health care in the wake of the Dobbs decision, and outline concerns that additional restrictions on access to medication abortion threaten to further increase the maternal mortality rate.

The Members conclude by asking the Fifth Circuit to reverse the district court’s decision, writing: “[t]he district court’s order not only misapplies the law but also threatens to harm members of the public, many of whom rely on the availability of mifepristone for reproductive care—and many more of whom rely on the integrity of FDA’s drug approval process for continued access to life-improving and lifesaving drugs. Congress intended to—and did—vest authority in FDA to evaluate and ensure the safety and efficacy of drugs in the United States, and amici call on this Court to give due weight to that intent.”

Since the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, abortion has become inaccessible in much of the United States. The resulting delays and denials of care have already had baleful effects on the health of pregnant individuals, for some of whom pregnancy is a life-threatening condition, regardless of their desire to carry their fetus to term. If left to stand, the district court’s order would exacerbate these adverse health outcomes by eliminating access to the most common method of early abortion—a two drug regimen of mifepristone and misoprostol. Moreover, eliminating access to mifepristone—also used in combination with misoprostol for the management of early miscarriage—will mean fewer options for treating early pregnancy loss, which includes a spontaneous abortion, missed abortion, incomplete abortion, or inevitable abortion—conditions that can be life-threatening, including posing a risk of sepsis or loss of future pregnancy capacity if not treated quickly.

In the House, the brief was signed by 203 Representatives. The lawmakers’ amicus brief to the Fifth Circuit can be read in full HERE.

Since last year’s leaked draft opinion indicated the Supreme Court’s intent to overturn the reproductive care precedent established under Roe v. Wade, Sen. Cantwell has been acting aggressively to protect abortion access for women across the country. In June 2022, Sen. Cantwell cosponsored the My Body, My Data Act to protect personal reproductive health data. In July 2022, following a meeting with health care providers at the University of Washington Medical Center, Sen. Cantwell cosponsored the Freedom to Travel for Health Care Act to ban anti-choice states from penalizing or prosecuting health care providers that offer reproductive services in states where abortion care is legal.

The same month, Sen. Cantwell also cosponsored the Right to Contraception Act, which would codify the right to contraception access established by the Supreme Court ruling Griswold v. Connecticut. In March, Sen. Cantwell joined Senator Patty Murray (D-WA) in reintroducing the Women’s Health Protection Act and hosting a roundtable discussion on the path forward to defend Americans’ reproductive rights. Last month, Sen. Cantwell joined hundreds of her Democratic colleagues in filing amicus briefs before the U.S. Supreme Court and Fifth Circuit Court of Appeals supporting the Biden Administration’s appeals of Texas federal district court and Fifth Circuit rulings which would restrict availability to mifepristone. The Supreme Court agreed to a stay, permitting the safe and legal drug to remain available for the time being, but the litigation is still pending in the lower courts. Last month, Sen. Cantwell spoke alongside veterans and reproductive rights groups at a press conference to oppose Republicans’ attempt to strip reproductive care from veterans and their families.