WASHINGTON – This week, Senator Peter Welch (D-VT) joined 240 Members of Congress, led by Senators Schumer, Murray, Sanders, Durbin, and Blumenthal and Representatives Jeffries, Clark, Pallone, Nadler, Lee, and DeGette, in filing an amicus brief with the U.S. Court of Appeals for the Fifth Circuit in the case of Alliance for Hippocratic Medicine v. FDA. The brief supports 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 in Vermont and nationwide—as well as FDA’s congressionally-mandated authority and drug approval process.
“Judge Kacsmaryk’s recent ruling is profoundly dangerous and threatens abortion care for women across this country—even in places like Vermont where abortion is a constitutionally protected right,” said Sen. Welch. “I am proud to join more than 200 of my colleagues to support the Biden Administration’s efforts to ensure continued access to mifepristone and other FDA-approved drugs for patients across the United States.”
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. The brief asks 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,” write the lawmakers in their brief.
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.
“[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 write.
In the Senate, the amicus brief was signed by 50 Senators: Senators Welch, 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, Whitehouse, Wyden.
In the House, the brief was signed by 190 Representatives including: Representatives Jeffries, Clark, Pallone, Nadler, DeGette, and Barbara Lee.
The lawmakers’ amicus brief can be read in full HERE.
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