240 Members of Congress ask Fifth Circuit to stay district court ruling that threatens access to mifepristone nationwide—and access to all manner of other FDA-approved drugs

Washington (April 11, 2023) – Senator Edward J. Markey (D-Mass.) joined 239 members of Congress—led by Senators Charles Schumer (D-N.Y.), Patty Murray (D-Wash.), Bernie Sanders (I-Vt.), Dick Durbin (D-Ill.), and Richard Blumenthal (D-Conn.) and Representatives Hakeem Jeffries (NY-08), Katherine Clark (MA-05), Frank Pallone (NJ-06), Jerrold Nadler (NY-12), Barbara Lee (CA-12), and Diana DeGette (CO-01)—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, in support of the Biden administration’s appeal of federal district court judge Matthew J. Kacsmaryk’s Friday ruling that suspends the Food and Drug Administration’s (FDA) more than 20-year-old approval of mifepristone—threatening access to mifepristone for patients nationwide, as well as FDA’s Congressionally-mandated authority and drug approval process.

In the new amicus brief, the members of Congress underscore that the district court ruling has no basis in law, risks 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 jeopardizes 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 Court to stay 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,” wrote the lawmakers in their brief.

If the district court ruling were left to stand and were to go into effect, the members stress that not only could patients in every state be denied access to the most common form of abortion care—and a key drug used in miscarriage management—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.

“[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,” wrote 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 stated.

The members also explain that Congress specifically designed FDA’s expert-driven drug approval process to ensure that the medications relied on by Americans every day are safe and effective. FDA followed that careful review process before it approved mifepristone for use in 2000, and its approval has been repeatedly affirmed in the more than 20 years since.

“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 wrote. “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 concluded 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 Senator Markey, the amicus brief was signed by 49 senators: Senators Schumer, Murray, Sanders, Durbin, Blumenthal, Tammy Baldwin (D-Wis.), Michael Bennet (D-Colo.), Cory Booker (D-N.J.), Sherrod Brown (D-Ohio), Maria Cantwell (D-Wash.), Ben Cardin (D-Md.), Tom Carper (D-Del.), Bob Casey Jr. (D-Pa.), Chris Coons (D-Del.), Catherine Cortez Masto (D-Nev.), Tammy Duckworth (D-Ill.), Dianne Feinstein (D-Calif.), John Fetterman (D-Pa.), Kirsten Gillibrand (D-N.Y.), Maggie Hassan (D-N.H.), Martin Heinrich (D-N.M.), John Hickenlooper (D-Colo.), Mazie Hirono (D-Hawaii), Tim Kaine (D-Va.), Mark Kelly (D-Ariz.), Angus King (D-Maine), Amy Klobuchar (D-Minn.), Ben Ray Luján (D-N.M.), Bob Menendez (D-N.J.), Jeff Merkley (D-Ore.), Chris Murphy (D-Conn.), Jon Ossoff (D-Ga.), Alex Padilla (D-Calif.), Gary Peters (D-Mich.), Jack Reed (D-R.I.), Jacky Rosen (D-Nev.), Brian Schatz (D-Hawaii), Jeanne Shaheen (D-N.H.), Krysten Sinema (I-Ariz.), Tina Smith (D-Minn.), Debbie Stabenow (D-Mich.), Jon Tester (D-Mont.), Chris Van Hollen (D-Md.), Mark Warner (D-Va.), Raphael Warnock (D-Ga.), Elizabeth Warren (D-Mass.),Peter Welch (D-Vt.), Sheldon Whitehouse (D-R.I.), and Ron Wyden (D-Ore.).

In the House, the brief was signed by 190 representatives: Representatives Jeffries, Clark, Pallone, Nadler, DeGette, Lee, Alma Adams (NC-12), Colin Allred (TX-32), Pete Aguilar (CA-33), Jake Auchincloss (MA-04), Becca Balint (VT), Nanette Barragán (CA-44), Joyce Beatty (OH-03), Ami Bera (CA-06), Don Beyer (VA-08), Sanford Bishop (GA-02), Earl Blumenauer (OR-03), Lisa Blunt Rochester (DE), Suzanne Bonamici (OR-01), Jamaal Bowman (NY-16), Brendan Boyle (PA-02), Shontel Brown (OH-11), Julia Brownley (CA-26), Nikki Budzinski (IL-13), Cori Bush (MO-01), Yadira Caraveo (CO-08), Salud Carbajal (CA-24), Tony Cárdenas (CA-29), Troy Carter (LA-02), Matt Cartwright (PA-08), Greg Casar (TX-35), Ed Case (HI-01), Sean Casten (IL-06), Kathy Castor (FL-14), Joaquin Castro (TX-20), Sheila Cherfilus-McCormick (FL-20), Judy Chu (CA-28), David Cicilline (RI-01), Yvette Clarke (NY-09), Emanuel Cleaver (MO-05), James E. Clyburn (SC-06), Steve Cohen (TN-09), Gerry Connolly (VA-11), Joe Courtney (CT-02), Angie Craig (MN-02), Jasmine Crockett (TX-30), Jason Crow (CO-06), Sharice Davids (KS-03), Danny K. Davis (IL-07), Madeleine Dean (PA-04), Rosa DeLauro (CT-03), Suzane DelBene (WA-01), Chris Deluzio (PA-17), Mark DeSaulnier (CA-10), Debbie Dingell (MI-06), Llyod Doggett (TX-37), Veronica Escobar (TX-16), Anna Eshoo (CA-16), Adriano Espaillat (NY-13), Dwight Evans (PA-03), Lizzie Fletcher (TX-07), Bill Foster (IL-11), Valerie Foushee (NC-04), Lois Frankel (FL-22), Maxwell Frost (FL-10), Ruben Gallego (AZ-03), John Garamendi (CA-08), Robert Garcia (CA-42), Jesus García (IL-04), Kristina Gluesenkamp Perez (WA-03), Dan Goldman (NY-10), Jimmy Gomez (CA-34), Josh Gottheimer (NJ-05), Al Green (TX-09), Raúl Grijalva (AZ-07), Brian Higgins (NY-26), Jim Himes (CT-04), Eleanor Holmes Norton (DC), Steven Horsford (NV-04), Chrissy Houlahan (PA-06), Steny Hoyer (MD-05), Val Hoyle (OR-04), Jared Huffman (CA-02), Glenn Ivey (MD-04), Sheila Jackson Lee (TX-18), Sara Jacobs (CA-51), Pramila Jayapal (WA-07), Hank Johnson (GA-04), Sydney Kamlager-Dove (CA-37), Marcy Kaptur (OH-09), Robin Kelly (IL-02), Ro Khanna (CA-17), Dan Kildee (MI-08), Derek Kilmer (WA-06), Andrew Kim (NJ-03), Raja Krishnamoorthi (IL-08), Annie Kuster (NH-02), Greg Landsman (OH-01), John Larson (CT-01), Susie Lee (NV-03), Summer Lee (PA- 12), Teresa Fernández (NM-03), Mike Levin (CA-49), Ted Lieu (CA-36), Zoe Lofgren (CA-18), Stephen Lynch (MA-08), Seth Magaziner (RI-02), Kathy Manning (NC-06), Doris Matsui (CA-07), Jennifer McClellan (VA-04), Betty McCollum (MN-04), Jim McGovern (MA-02), Gregory Meeks (NY-05), Robert Menendez (NJ-08), Grace Meng (NY-06), Gwen Moore (WI-04), Joe Morelle (NY-25), Jared Moskowitz (FL-23), Kevin Mullin (CA-15), Grace Napolitano (CA-31), Richard Neal (MA-01), Joe Neguse (CO-02), Wiely Nickel (NC-13), Donald Norcross (NJ-01), Alexandria Ocasio-Cortez (NY-14), Illhan Omar (MN-05), Jimmy Panetta (CA-19), Chris Pappas (NH-01), Bill Pascrell (NJ-09), Donald Payne (NJ-10), Nancy Pelosi (CA-11), Mary Sattler Peltola (AK), Scott Peters (CA-50), Brittany Pettersen (CO-07), Dean Phillips (MN-03), Chellie Pingree (ME-01), Mark Pocan (WI-02), Katie Porter (CA-47), Ayanna Pressley (MA-07), Mike Quigley (IL-05), Jamie Raskin (MD-08), Deborah Ross (NC-02), Paul Ruiz (CA-25), Dutch Ruppersberger (MD-02), Pat Ryan (NY-18), Gregorio Sablan (CNMI), Andrea Salinas (OR-06), Linda Sánchez (CA-38), John Sarbanes (MD-03), Mary Gay Scanlon (PA-05), Jan Schakowsky (IL-09), Adam Schiff (CA-30), Hillary Scholten (MI-03), Kim Schrier (WA-08), Bobby Scott (VA-03), Terri Sewell (AK-07), Brad Sherman (CA-32), Mike Sherrill (NJ-11), Elissa Slotkin (MI-07), Adam Smith (WA-09), Eric Sorensen (IL-17), Darren Soto (FL-09), Abigail Spanberger (VA-07), Melanie Stansbury (NM-01), Greg Stanton (AZ-04), Haley Stevens (MI-11), Marilyn Strickland (WA-10), Eric Swalwell (CA-14), Emilia Sykes (OH-13), Mark Takano (CA-39), Mike Thompson (CA-04), Dina Titus (NV-01), Rashida Tlaib (MI-12), Jill Tokuda (HI-02), Paul Tonko (NY-20), Ritchie Torres (NY-15), Norma Torres (CA-35), Lori Trahan (MA-03), David Trone (MD-06), Lauren Underwood (IL-14), Gabriel Vasquez (NM-02), Marc Veasey (TX-33), Nydia Velázquez (NY-07), Debbie Wasserman Schultz (FL-25), Maxine Waters (CA-43), Bonnie Watson Coleman (NJ-12), Jennifer Wexton (VA-10), Susan Wild (PA-07), Nikema Williams (GA-05), and Frederica Wilson (FL-24).

The lawmakers’ amicus brief can be read in full HERE.