Warner, Kaine, & Colleagues Urge Appeals Court to Prevent Dangerous Ruling Threatening Access to Mifepristone from Taking Effect

WASHINGTON, D.C. – Today, following a federal district court judge’s ruling suspending the Food and Drug Administration (FDA)’s 2000 approval of mifepristone, U.S. Senators Mark R. Warner and Tim Kaine, along with 238 other members of Congress, submitted an amicus brief urging a higher court to prevent that dangerous ruling from going into effect. Mifepristone is a safe and effective medication that has been widely used for abortion care and miscarriage management for over two decades. The Department of Justice announced on Monday that it would appeal the lower court ruling and ask the Fifth Circuit to stop the ruling from going into effect.

The lawmakers’ brief underscores that the district court ruling denies access to mifepristone in every state, posing serious health risks to pregnant patients, and jeopardizes patients’ access to other medications by threatening FDA’s drug approval process, which was mandated by Congress. Accordingly, the brief asks the Fifth Circuit to pause the district court’s order.

“The district court appears to have second-guessed FDA’s scientific determinations with cherry-picked anecdotes and studies, and on that basis, imposed a remedy that could significantly upend the status quo,” write the lawmakers in their brief.

If the Fifth Circuit allows the district court ruling to go into effect, the members stress that patients in every state may be denied access to the most common form of abortion care and a key drug used in miscarriage management. This ruling would also undermine FDA’s authority to determine the safety and efficacy of other drugs , threatening patients’ access to medications. The members also explain that Congress specifically designed FDA’s expert-driven drug approval process to ensure that the medications relied on by Americans are safe and effective. FDA followed that careful review process in its approval of mifepristone for use in 2000, and that approval has been repeatedly affirmed in the more than 20 years since.

“[T]he district court’s misguided stay under Section 705 of the Administrative Procedure Act will reduce access to abortion, exacerbating an already significant reproductive health crisis,” write the lawmakers, adding: “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.”

“Its perilous consequences reach far beyond mifepristone. 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 state.

“For the last century, a statutory scheme designed by Congress has assured the safety and effectiveness of the drugs available in the United States. At its core resides the application of scientific standards by agency experts,” the lawmakers write. “Here, 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 reaffirmed 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 lawmakers conclude by asking the Fifth Circuit to stay the decision, writing: “emergency relief from the order is necessary to mitigate the imminent harm facing members of the public, many of whom rely on the availability of mifepristone for reproductive care—and many more rely on the integrity of FDA’s drug approval process for continued access to life-improving and life-saving 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.” 

In addition to Warner and Kaine, the amicus brief was signed by U.S. Senators Chuck Schumer (D-NY), Patty Murray (D-WA), Bernie Sanders (I-VT), Dick Durbin (D-IL), Richard Blumenthal (D-CT), Tammy Baldwin (D-WI), Michael Bennet (D-CO), Cory Booker (D-NJ), Sherrod Brown (D-OH), Maria Cantwell (D-WA), Ben Cardin (D-MD), Tom Carper (D-DE), Bob Casey Jr. (D-PA), Chris Coons (D-DE), Catherine Cortez Masto (D-NV), Tammy Duckworth (D-IL), Dianne Feinstein (D-CA), John Fetterman (D-PA), Kirsten Gillibrand (D-NY), Maggie Hassan (D-NH), Martin Heinrich (D-NM), John Hickenlooper (D-CO), Mazie K. Hirono (D-HI), Mark Kelly (D-AZ), Angus King (I-ME), Amy Klobuchar (D-MN), Ben Ray Luján (D-NM), Edward J. Markey (D-MA), Bob Menendez (D-NJ), Jeff Merkley (D-OR), Chris Murphy (D-CT), Jon Ossoff (D-GA), Alex Padilla (D-CA), Gary Peters (D-MI), Jack Reed (D-RI), Jacky Rosen (D-NV), Brian Schatz (D-HI), Jeanne Shaheen (D-NH), Kyrsten Sinema (I-AZ), Tina Smith (D-MN), Debbie Stabenow (D-MI), Jon Tester (D-MT), Chris Van Hollen (D-MD), Raphael Warnock (D-GA), Elizabeth Warren (D-MA), Peter Welch (D-VT), Sheldon Whitehouse (D-RI), and Ron Wyden (D-OR). 190 members of the House of Representatives also signed the amicus brief.

The amicus brief is available here.

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