Source: United States Senator for Maine Angus King
WASHINGTON, D.C. – U.S Senator Angus King and 252 other Members of Congress have written to the U.S. Supreme Court in support of the Biden administration’s appeal of a federal district court ruling in Alliance for Hippocratic Medicine v. FDA, that suspends the Food and Drug Administration’s (FDA) more than 20-year-old approval of mifepristone – a safe and effective medication widely used in abortion care and miscarriage management for years.
In the new amicus brief, the Members of Congress continue to underscore that neither the recent appeals court nor district court rulings that limit mifepristone access have any basis in law. The rulings also risk denying patients access to critical healthcare and jeopardize patients’ access to a wide array of other medications by threatening FDA’s drug approval process as it was designed by Congress.
The Members of Congress urge the Supreme Court to pause the lower court rulings – known as “granting a stay” – from the United States Court of Appeals for the Fifth Circuit and Judge Matthew Kacsmaryk’s district court, while the appeal process is ongoing.
“[T]he district court appears to have second-guessed FDA’s expert 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. “[I]t is an extraordinary and unprecedented step for the district court to invalidate on substantive grounds—and over FDA’s objection—a longstanding approval for a drug with a history of safe and effective use. This Court should stay the entirety of that aberrant decision pending appellate review.”
If the district court ruling were left to stand and 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.
“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. “By permitting the district court to disrupt FDA’s current regulation of mifepristone, the Fifth Circuit has countenanced judicial interference that erroneously substitutes the district court’s judgment for FDA’s scientific determination.”
“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,” the lawmakers state.
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 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 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.”
In the Senate, the amicus brief was signed by 50 Senators: Senators Schumer, Murray, Sanders, Durbin, Blumenthal, Baldwin, Bennet, Booker, Brown, Cantwell, Cardin, Carper, Casey Jr., Coons, Cortez Masto, Duckworth, Feinstein, Fetterman, Gillibrand, Hassan, Heinrich, Hickenlooper, Hirono, Kaine, Kelly, King, Klobuchar, Luján, Markey, Menendez, Merkley, Murphy, Ossoff, Padilla, Peters, Reed, Rosen, Schatz, Shaheen, Sinema, Smith, Stabenow, Tester, Van Hollen, Warner, Warnock, Warren, Welch, Whitehouse, Wyden.
In the House, the brief was signed by 203 Representatives: Representatives Jeffries, Clark, Pallone, Nadler, DeGette, Barbara Lee, Adams, Allred, Aguilar, Auchincloss, Balint, Barragán, Beatty, Bera, Beyer, Bishop, Blumenauer, Blunt Rochester, Bonamici, Bowman, Boyle, Brown, Brownley, Budzinski, Bush, Caraveo, Carbajal, Cárdenas, Carter, Cartwright, Casar, Case, Casten, Castor, Castro, Cherfilus-McCormick, Chu, Cicilline, Clarke, Cleaver, Clyburn, Cohen, Connolly, Correa, Courtney, Craig, Crockett, Crow, Davids, Davis, Dean, DeLauro, DelBene, Deluzio, DeSaulnier, Dingell, Doggett, Escobar, Eshoo, Espaillat, Evans, Fletcher, Foster, Foushee, Frankel, Frost, Gallego, Garamendi, R. Garcia, C. García, S. Garcia, Gluesenkamp Perez, Goldman, Gomez, Gottheimer, Green, Grijalva, Hayes, Higgins, Himes, Holmes Norton, Horsford, Houlahan, Hoyer, Hoyle, Huffman, Ivey, Jackson Lee, Jackson, Jacobs, Jayapal, Johnson, Kamlager-Dove, Kaptur, Keating, Kelly, Khanna, Kildee, Kilmer, Kim, Krishnamoorthi, Kuster, Landsman, Larson, Susie Lee, Summer Lee, Leger Fernandez, Levin, Lieu, Lofgren, Lynch, Magaziner, Manning, Matsui, McBath, McClellan, McCollum, McGarvey, McGovern, Meeks, Menendez, Meng, Mfume, Moore, Morelle, Moskowitz, Moulton, Mullin, Napolitano, Neal, Neguse, Nickel, Norcross, Ocasio-Cortez, Omar, Panetta, Pappas, Pascrell, Payne, Pelosi, Peltola, Peters, Pettersen, Phillips, Plaskett, Pingree, Pocan, Porter, Pressley, Quigley, Ramirez, Raskin, Ross, Ruiz, Ruppersberger, Ryan, Sablan, Salinas, Sánchez, Sarbanes, Scanlon, Schakowsky, Schiff, Schneider, Scholten, Schrier, Bobby Scott, David Scott, Sewell, Sherman, Sherrill, Slotkin, Smith, Sorensen, Soto, Spanberger, Stansbury, Stanton, Stevens, Strickland, Swalwell, Sykes, Takano, Thompson, Titus, Tlaib, Tokuda, Tonko, Ritchie Torres, Norma Torres, Trahan, Trone, Underwood, Vasquez, Veasey, Velázquez, Wasserman Schultz, Waters, Watson Coleman, Wexton, Wild, Williams, Wilson.
The lawmakers’ amicus brief to the Supreme Court can be read in full HERE.
Last Tuesday, Members of Congress filed a previous amicus brief urging the Fifth Circuit to stay Judge Kacsmaryk’s district court ruling.
###