DeGette Leads Amicus Brief Urging Supreme Court to Reverse Dangerous Ruling That Would Restrict Access to Mifepristone Nationwide

U.S. Rep. Diana DeGette (D-CO), co-chair of the Pro-choice Caucus, led 263 Members of Congress — along with U.S. Senators Schumer, Murray, Sanders, Durbin, and Blumenthal and Representatives Jeffries, Clark, Pallone, Nadler, and Lee — on an amicus brief to the U.S. Supreme Court in the case of Alliance for Hippocratic Medicine v. FDA On Jan 30. This amicus brief urges the Supreme Court to reverse a stay from Texas District Court Judge Matthew Kacsmaryk, reaffirmed in part by the U.S. Court of Appeals for the Fifth Circuit, that would override the Food and Drug Administration (FDA)’s scientific judgment and dramatically curtail access to mifepristone — a safe and effective medication abortion drug that was approved by the FDA in 2000 and is used in more than half of all abortions in the U.S. At issue in the case are evidence-based regulatory actions the FDA took in 2016 and 2021 that broadened access to mifepristone, including extending the time frame for mifepristone use during the early stages of pregnancy and removing onerous in-person dispensing requirements for mifepristone.

If the Supreme Court affirms the Fifth Circuit’s decision upholding the district court’s stay of the FDA’s 2016 and 2021 actions, it would be effectively rolling back the clock on reproductive healthcare and overriding FDA’s robust scientific approvals process — with immediate and sweeping consequences in every state on the ability of patients to access mifepristone for safe abortion care and miscarriage management.

DeGette leads amicus brief urging Supreme Court to reverse dangerous ruling that would restrict access to mifepristone nationwide
263 Members of Congress ask Supreme Court to reverse Fifth Circuit ruling that could dramatically curtail access to mifepristone nationwide & upend FDA approval process
Washington, D.C. — Today,

In the new amicus brief, the Members of Congress underscore that both the appeals court and the district court rulings threaten the congressionally-mandated drug approval process, and pose a serious health risk to pregnant individuals by making safe abortion care more difficult to access — when access has already been seriously eroded in the aftermath of the Dobbs v. Jackson Women’s Health Organization decision that overturned Roe v. Wade.

“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. 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 Members wrote.

If the Supreme Court upholds the Fifth Circuit’s ruling, the Members stress that not only could patients’ access in every state to the most common form of abortion care — and an important drug used in miscarriage management — be severely limited, but FDA’s authority to determine the safety and efficacy of other drugs would be put at risk, threatening patients’ access to all manner of other medications.

“The consequences of the Fifth Circuit’s decision 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 wrote. “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. Moreover, the prospect of courts second-guessing FDA’s rigorous drug safety and effectiveness determinations will disrupt industry expectations and could chill pharmaceutical research and development.”

In the Senate, the amicus brief was signed by 50 U.S. Senators. In the House, the brief was signed by 213 U.S. Representatives.

The lawmakers’ amicus brief to the Supreme Court can be read in full here.