Source: United States Senator for Maryland Chris Van Hollen
May 08, 2023
This week, U.S. Senators Chris Van Hollen and Ben Cardin (both D-Md.) joined their colleagues 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, urging the Court to reverse the district court’s stay on the FDA’s more than 20-year-old approval of mifepristone. In April, the Supreme Court issued a stay of the lower court ruling that allows mifepristone to remain on the market while the case is under review. This effort was led by Senate Majority Leader Chuck Schumer (D-N.Y.) and Senators Patty Murray (D-Wash.), Bernie Sanders (I-Vt.), Dick Durbin (D-Ill.), and Richard Blumenthal (D-Conn.).
The Members argued that the district court’s decision has no basis in law, poses a serious health risk to pregnant women and other individuals by 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 threatens 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 asked the Fifth Circuit to reverse the district court’s order.
“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,” the lawmakers wrote. “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 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,” the lawmakers continued. “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 cited reports from doctors and journalists highlighting the increased importance of mifepristone for reproductive health care in the wake of the Dobbs decision, and outlined concerns that additional restrictions on access to medication abortion threaten to further increase the maternal mortality rate.
The Members concluded by asking the Fifth Circuit to reverse the district court’s decision, writing: “[t]he district court’s order not only misapplies the law but also threatens to harm members of the public, many of whom rely on the availability of mifepristone for reproductive care—and many more of whom rely on the integrity of FDA’s drug approval process for continued access to life-improving and lifesaving 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.”
Since the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, abortion has become inaccessible in much of the United States. The resulting delays and denials of care have already had baleful effect on the health of pregnant individuals, for some of whom pregnancy is a life-threatening condition, regardless of their desire to carry their fetus to term. If left to stand, the district court’s order would exacerbate these adverse health outcomes by eliminating access to the most common method of early abortion—a two drug regimen of mifepristone and misoprostol. Moreover, eliminating access to mifepristone—also used in combination with misoprostol for the management of early miscarriage —will mean fewer options for treating early pregnancy loss, which includes a spontaneous abortion, missed abortion, incomplete abortion, or inevitable abortion—conditions that can be life-threatening, including posing a risk of sepsis or loss of future pregnancy capacity if not treated quickly.
In the Senate, the amicus brief, led by Senate Majority Leader Schumer and Senators Murray, Sanders, Durbin, and Blumenthal, was signed, in addition to Senators Van Hollen and Cardin, by Senators Tammy Baldwin (D-Wis.), Michael Bennet (D-Colo.), Cory Booker (D-N.J.), Sherrod Brown (D-Ohio), Maria Cantwell (D-Wash.), 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 (I-Maine), Amy Klobuchar (D-Minn.), Ben Ray Luján (D-N.M.), Edward J. Markey (D-Mass.), 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.), Kyrsten Sinema (I-Ariz.), Tina Smith (D-Minn.), Debbie Stabenow (D-Mich.), Jon Tester (D-Mont.), Mark Warner (D-Va.), Rev. 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, led by House Minority Leader Hakeem Jeffries and Representatives Katherine Clark, Frank Pallone, Jerry Nadler, Barbara Lee, and Diana DeGette, was signed by Representatives 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, Kusters, 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 Fifth Circuit can be read in full HERE.