Heinrich, Luján File Amicus Brief Urging Appeals Court to Prevent Dangerous Ruling Threatening Access to Mifepristone From Taking Effect

WASHINGTON - Yesterday, U.S. Senators Martin Heinrich (D-N.M.) and Ben Ray Luján (D-N.M.) submitted 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, Heinrich, Luján, and over 240 members of Congress underscore that the district court ruling has no basis in law and 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. It also jeopardizes 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 ask the court to stay the district court’s order.

 

“The district court appears to have second-guessed FDA’s scientific determination with cherry-picked anecdotes and studies, and on that basis, imposed a remedy that could significantly upend the status quo,” write Heinrich, Luján, and the lawmakers.

 

If the district court ruling were left to stand and go into effect, the lawmakers stress that patients in every state be denied access to the most common form of abortion care—and a key drug used in miscarriage management. And FDA’s authority to determine the safety and efficacy of other drugs also would be put at risk, threatening patients’ access to all types of other medications.

 

“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,” write the lawmakers. “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 reaffirmed that the medication is safe and effective for its intended 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 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 Senators Heinrich and Luján, the brief was signed by 48 senators, including U.S. Senators Chuck Schumer (D-N.Y.), Patty Murray (D-Wash.), Bernie Sanders (I-Vt.), Dick Durbin (D-Ill.), Richard Blumenthal (D-Conn.), Tammy Baldwin (D-Wis.), Michael Bennet (D-Colo.), Cory Booker (D-N.J.), Sherrod Brown (D-Ohio), Maria Cantwell (D-Wash.), Ben Cardin (D-Md.), 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.), John Hickenlooper (D-Colo.), Mazie Hirono (D-Hawaii), Tim Kaine (D-Va.), Mark Kelly (D-Ariz.), Angus King (I-Maine), Amy Klobuchar (D-Minn.), , Ed Markey (D-Mass.), Robert 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.), Chris Van Hollen (D-Md.), Mark Warner (D-Va.), Raphael Warnock (D-Ga.), Elizabeth Warren (D-Mass.), Peter Welch (D-Vt.), Sheldon Whitehouse (D-R.I.), and Ron Wyden (D-Ore.). The brief was also signed by 190 members of the House of Representatives.

 

The text of the amicus brief is available HERE.