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

April 12, 2023 - WASHINGTON, D.C. — On Tuesday, U.S. Senator Alex Padilla (D-Calif.) joined 239 Congressional Democrats in submitting an amicus brief to the U.S. Court of Appeals for the Fifth Circuit in the case Alliance for Hippocratic Medicine v. FDA. The amicus brief is in support of the Department of Justice’s appeal of federal District Court Judge Matthew J. Kacsmaryk’s Friday ruling that attempts to suspend the Food and Drug Administration’s (FDA) more than 20-year-old approval of mifepristone—threatening access to the medication for patients nationwide as well as FDA’s Congressionally-mandated authority and drug approval process.

Members of Congress filed this friend of the court brief to protect their interest both in delegating authority to the FDA to safely regulate drugs and in our nation’s crucial separation of powers. In the new amicus brief, the lawmakers 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—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 determination 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 district court ruling were left to stand and go into effect, the lawmakers stress that not only could patients in every state be denied access to the most common form of abortion care, 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,” 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. 

The lawmakers 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 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 intended 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 Padilla, the amicus brief was signed by 49 Senators: Senators Schumer (D-N.Y.), Murray (D-Wash.), Sanders (I-Vt.), Durbin (D-Ill.), Blumenthal (D-Conn.), Baldwin (D-Wis.), Bennet (D-Colo.), Booker (D-N.J.), Brown (D-Ohio), Cantwell (D-Wash.), Cardin (D-Md.), Carper (D-Del.), Casey Jr. (D-Pa.), Coons (D-Del.), Cortez Masto (D-Nev.), Duckworth (D-Ill.), Feinstein (D-Calif.), Fetterman (D-Pa.), Gillibrand (D-N.Y.), Hassan (D-N.H.), Heinrich (D-N.M.), Hickenlooper (D-Colo.), Hirono (D-Hawaii), Kaine (D-Va.), Kelly (D-Ariz.), King (D-Maine), Klobuchar (D-Minn.), Luján (D-N.M.), Markey (D-Mass.), Menendez (D-N.J.), Merkley (D-Ore.), Murphy (D-Conn.), Ossoff (D-Ga.), Peters (D-Mich.), Reed (D-R.I.), Rosen (D-Nev.), Schatz (D-Hawaii), Shaheen (D-N.H.), Sinema (I-Ariz.), Smith (D-Minn.), Stabenow (D-Mich.), Tester (D-Mont.), Van Hollen (D-Md.), Warner (D-Va.), Warnock (D-Ga.), Warren (D-Mass.), Welch (D-Vt.), Whitehouse (D-R.I.), Wyden (D-Ore.).

In the House, the brief was signed by 190 Representatives: Representatives Jeffries (D-N.Y.-08), Clark (D-Mass.-05), Pallone (D-N.J.-06), Nadler (D-N.Y.-12), DeGette (D-Colo.-01), Barbara Lee (D-Calif.-12), Adams (D-N.C.-12), Allred (D-Tex.-32), Aguilar (D-Calif.-33), Auchincloss (D-Mass.-04), Balint (D-Vt.-At-Large), Barragán (D-Calif.-44), Beatty (D-Ohio-03), Bera (D-Calif.-06), Beyer (D-Va.-08), Bishop (D-Ga.-02), Blumenauer (D-Ore.-03), Blunt Rochester (D-Del.-At-Large), Bonamici (D-Ore.-01), Bowman (D-N.Y.-16), Boyle (D-Pa.-02), Brown (D-Ohio-11), Brownley (D-Calif.-26), Budzinski (D-Ill.-13), Bush (D-Mo.-01), Caraveo (D-Colo.-08), Carbajal (D-Calif.-24), Cárdenas (D-Calif.-29), Carter (D-La.-02), Cartwright (D-Pa.-08), Casar (D-Tex.-35), Case (D-Hawaii-01), Casten (D-Ill.-06), Castor (D-Fla.-14), Castro (D-Tex.-20), Cherfilus-McCormick (D-Fla.-20), Chu (D-Calif.-28), Cicilline (D-R.I.-01), Clarke (D-N.Y.-09), Cleaver (D-Mo.-05), Clyburn (D-S.C.-06), Cohen (D-Tenn.-09), Connolly (D-Va.-11), Courtney (D-Conn.-02), Craig (D-Minn.-02), Crockett (D-Tex.-30), Crow (D-Colo.-06), Davids (D-Kans.-03), Davis (D-Ill.-07), Dean (D-Pa.-04), DeLauro (D-Conn.-03), DelBene (D-Wash.-01), Deluzio (D-Pa.-17), DeSaulnier (D-Calif.-10), Dingell (D-Mich.-06), Doggett (D-Tex.-37), Escobar (D-Tex.-16), Eshoo (D-Calif.-16), Espaillat (D-N.Y.-13), Evans (D-Pa.-03), Fletcher (D-Tex.-07), Foster (D-Ill.-11), Foushee (D-N.C.-04), Frankel (D-Fla.-22), Frost (D-Fla.-10), Gallego (D-Ariz.-03), Garamendi (D-Calif.-08), R. Garcia (D-Calif.-42), C. García (D-Ill.-04), Gluesenkamp Perez (D-Wash.-03), Goldman (D-N.Y.-10), Gomez (D-Calif.-34), Gottheimer (D-N.J.-05), Green (D-Tex.-09), Grijalva (D-Ariz.-07), Higgins (D-N.Y.-26), Himes (D-Conn.-04), Holmes Norton (D-D.C.), Horsford (D-Nev.-04), Houlahan (D-Pa.-06), Hoyer (D-Md.-05), Hoyle (D-Ore.-04), Huffman (D-Calif.-02), Ivey (D-Md.-04), Jackson Lee (D-Tex.-18), Jacobs (D-Calif.-51), Jayapal (D-Wash.-07), Johnson (D-Ga.-04), Kamlager-Dove (D-Calif.-37), Kaptur (D-Ohio-09, Kelly (D-Ill.-02), Khanna (D-Calif.-17), Kildee (D-Mich.-08), Kilmer (D-Wash.-06), Kim (D-N.J.-03), Krishnamoorthi (D-Ill.-08), Kuster (D-N.H.-02), Landsman (D-Ohio-01), Larson (D-Conn.-01), Susie Lee (D-Nev.-03), Summer Lee (D-Pa.-12), Leger Fernandez (D-N.M.-03), Levin (D-Calif.-49), Lieu (D-Calif.-36), Lofgren (D-Calif.-18), Lynch (D-Mass.-08), Magaziner (D-R.I.-02), Manning (D-N.C.-06), Matsui (D-Calif.-07), McClellan (D-Va.-04), McCollum (D-Minn.-04), McGovern (D-Mass.-02), Meeks (D-N.Y.-05), Menendez (D-N.J.-08), Meng (D-N.Y.-06), Moore (D-Wis.-04), Morelle (D-N.Y.-25), Moskowitz (D-Fla.-23), Mullin (D-Calif.-15), Napolitano (D-Calif.-31), Neal (D-Mass.-01), Neguse (D-Colo.-02), Nickel (D-N.C.-13), Norcross (D-N.J.-01), Ocasio-Cortez (D-N.Y.-14), Omar (D-Minn.-5), Panetta (D-Calif.-19), Pappas (D-N.H.-01), Pascrell (D-N.J.-09), Payne (D-N.J.-10), Pelosi (D-Calif.-11), Peltola (D-Alaska-At-Large), Peters (D-Calif.-50), Pettersen (D-Colo.-07), Phillips (D-Minn.-03), Pingree (D-Maine-01), Pocan (D-Wis.-02), Porter (D-Calif.-47), Pressley (D-Mass.-07), Quigley (D-Ill.-05), Raskin (D-Md.-08), Ross (D-N.C.-02), Ruiz (D-Calif.-25), Ruppersberger (D-Md.02), Ryan (D-N.Y.-18), Sablan (D-Northern Marian Islands), Salinas (D-Ore.-06), Sánchez (D-Calif.-38), Sarbanes (D-Md.-03), Scanlon (D-Pa.-05), Schakowsky (D-Ill.-09), Schiff (D-Calif.-30), Scholten (D-Mich.-03), Schrier (D-Wash.-08), Bobby Scott (D-Va.-03), Sewell (D-Ala.-07), Sherman (D-Calif.-32), Sherrill (D-N.J.-11), Slotkin (D-Mich.-07), Smith (D-Wash.-09), Sorensen (D-Ill.-17), Soto (D-Fla.-09), Spanberger (D-Va.-07), Stansbury (D-N.M.-01), Stanton (D-Ariz.-04), Stevens (D-Mich.-11), Strickland (D-Wash. 10), Swalwell (D-Calif.-14), Sykes (D-Ohio-13), Takano (D-Calif.-39), Thompson (D-Calif.-04), Titus (D-Nev.-01), Tlaib (D-Mich-12), Tokuda (D-Hawaii-02), Tonko (D-N.Y.-20), Ritchie Torres (D-N.Y.-15), Norma Torres (D-Calif.-35), Trahan (D-Mass.-03), Trone (D-Md.-06), Underwood (D-Ill.-14), Vasquez (D-N.M.-02), Veasey (D-Tex.-33), Velázquez (D-N.Y.-07), Wasserman Schultz (D-Fla.-25), Waters (D-Calif.-43), Watson Coleman (D-N.J.-12), Wexton (D-Va.-10), Wild (D-Pa.-07), Williams (D-Ga.-05), Wilson (D-Fla.-24).

The lawmakers’ amicus brief can be read in full HERE.
Source: Senator Alex Padilla