WCBC

April 15th, 2023 by WCBC Radio

U.S. Senators Chris Van Hollen and Ben Cardin (both D-Md.) joined Senate Majority Leader Chuck Schumer and Senators Patty Murray (D-Wash.), Bernie Sanders (I-Vt.), Dick Durbin (D-Ill.), and Richard Blumenthal (D-Conn.) and other congressional colleagues in submitting an amicus brief to the U.S. Supreme Court in the case of Alliance for Hippocratic Medicine v. FDA, in support of the Biden administration’s appeal of a federal district court ruling that suspends the Food and Drug Administration’s (FDA) more than 20-year-old approval of mifepristone as well as the decision by the Court of Appeals for the Fifth Circuit—which does not revoke FDA approval of mifepristone in its entirety but does significantly restrict access to the drug nationwide and ultimately overrides FDA’s scientific judgement.

The Members of Congress urged the Supreme Court to grant emergency relief from the United States Court of Appeals for the Fifth Circuit’s partial denial of a stay pending appeal, and stay Judge Matthew Kacsmaryk’s district court order in its entirety.

In the new amicus brief, the Members of Congress continue to underscore that neither the appeals court nor district court rulings have any basis in law, risk 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 jeopardize patients’ access to a wide array of other medications by threatening FDA’s drug approval process, which was designed and mandated by Congress.

 “[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,” wrote 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.”

The lawmakers went on to make clear the Fifth Circuit’s decision to maintain Judge Kacsmaryk’s stay of mifepristone’s current, FDA-approved conditions of use disrupts longstanding statutory framework, calling attention to the fact that the district court’s ruling comes decades after FDA’s initial approval.  

“Decades after FDA’s initial approval—yet somehow in an emergency posture—the district court intruded into FDA’s drug approval process, casting a shadow of uncertainty over its decisions.  The perils of this unwarranted judicial intervention into science-based determinations can hardly be overstated.  Researchers, health care providers, and patients suffering from a range of medical conditions rely on the integrity and stability of the rigorous science-based drug approval process.  The specter of precipitous judicial meddling therefore threatens access to life-improving and lifesaving drugs,” they state.

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 noted.

The Members also explained 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 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 lawmakers also made clear that the Fifth Circuit’s decision late Wednesday maintains the severely disruptive and dangerous effects of the original ruling, and would still exacerbate an already significant reproductive health care crisis.

“Although the district court styled its relief as ‘less drastic,’ it is not apparent that its consequences are less disruptive than those of a mandatory injunction,” continued the lawmakers. “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 effects 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.  The Fifth Circuit’s order would exacerbate these adverse health outcomes by limiting access to the most common method of early abortion—a two drug regimen of mifepristone and misoprostol.”

The lawmakers concluded by asking the Supreme Court for emergency relief from the decision, writing: “Therefore, 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 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.”

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, 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.

On Tuesday, Members of Congress filed a previous amicus brief urging the Fifth Circuit to stay Judge Kacsmaryk’s district court ruling.