Washington, D.C. — Colorado U.S. Senators Michael Bennet and John Hickenlooper submitted 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. 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, Bennet, Hickenlooper, and over 250 members of Congress 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 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 lawmakers 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.
“[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,” write Bennet, Hickenlooper, and the lawmakers. “[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 go 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.”
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 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,” wrote the lawmakers “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,” stated 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 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,” wrote 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 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 make 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,” write 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 conclude 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 addition to Bennet and Hickenlooper, 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.), 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.), Martin Heinrich (D-N.M.), 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.), 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 203 members of the House of Representatives.
The text of the amicus brief is available HERE.