Source: United States Senator for Rhode Island Sheldon Whitehouse
04.12.23
50 Democratic and Independent U.S. Senators Urge Fifth Circuit to Stay District Court Ruling That Threatens Access to Mifepristone Nationwide—and Access to All Manner of Other FDA-Approved Drugs
PROVIDENCE, RI — U.S. Senators Jack Reed (D-RI) and Sheldon Whitehouse (D-RI) joined an amicus brief to the U.S. Court of Appeals for the Fifth Circuit in the case of Alliance for Hippocratic Medicine v. FDA, in support of the Biden administration’s appeal of Judge Matthew J. Kacsmaryk’s ruling that suspends the Food and Drug Administration’s (FDA) more than 20-year-old approval of mifepristone. This ruling threatens access to mifepristone for patients nationwide, as well as FDA’s Congressionally-mandated independent authority and drug approval process.
In the amicus brief, Reed, Whitehouse, and 48 other U.S. Senators 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 entire drug approval process, which was designed and mandated by Congress. Accordingly, they ask the court to stay the district court’s order.
“[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 Reed, Whitehouse, and the members of Congress who signed the amicus 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—and a key drug used in miscarriage management—but the 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,” continue the lawmakers.
The lawmakers also explain that Congress specifically designed FDA’s expert-driven drug approval process to ensure that the medications relied on by Americans 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 continued. “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 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 of whom 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 Reed and Whitehouse, the brief was signed by 48 senators, including U.S. Senators Patty Murray (D-WA), Chuck Schumer (D-NY), Bernie Sanders (I-VT), Dick Durbin (D-IL), Michael Bennet (D-CO), Richard Blumenthal (D-CT), Tammy Baldwin (D-WI), Cory Booker (D-NJ), Sherrod Brown (D-OH), Maria Cantwell (D-WA), Ben Cardin (D-Md.), Tom Carper (D-DE), Bob Casey Jr. (D-PA), Chris Coons (D-DE), Catherine Cortez Masto (D-NV), Tammy Duckworth (D-IL), Dianne Feinstein (D-CA), John Fetterman (D-PA), Kirsten Gillibrand (D-NY), Maggie Hassan (D-NH), Martin Heinrich (D-NM), John Hickenlooper (D-CO) Mazie Hirono (D-HI), Tim Kaine (D-VA), Mark Kelly (D-AZ), Angus King (I-ME), Amy Klobuchar (D-MN), Ben Ray Luján (D-NM), Ed Markey (D-MA), Robert Menendez (D-NJ), Jeff Merkley (D-OR), Chris Murphy (D-CT), Jon Ossoff (D-GA), Alex Padilla (D-CA), Gary Peters (D-MI), Jacky Rosen (D-NV), Brian Schatz (D-HI), Jeanne Shaheen (D-NH), Kyrsten Sinema (I-AZ), Tina Smith (D-MN), Debbie Stabenow (D-MI), Jon Tester (D-MT), Chris Van Hollen (D-MD), Mark Warner (D-VA), Raphael Warnock (D-GA), Elizabeth Warren (D-MA), Peter Welch (D-VT), and Ron Wyden (D-OR).
The brief was also signed by 190 members of the U.S. House of Representatives.
Text of the 65-page amicus brief is available HERE.