Cantwell, Congressional Democrats File Amicus Brief Urging Supreme Court to Reject Radical Lower Court Decision to Restrict Mifepristone Access

If upheld, Fifth Circuit ruling would limit mifepristone access for patients nationwide

WASHINGTON, D.C. – Today, U.S. Senator Maria Cantwell (D-WA) joined 263 members of Congress in submitting an amicus brief to the U.S. Supreme Court in the case of FDA v. Alliance for Hippocratic Medicine. The court announced yesterday that oral arguments in the case will be held on Tuesday, March 26. 

In the amicus brief, the members urged the court to reverse the Fifth Circuit Court of Appeals’ ruling that would restrict access to mifepristone, a key abortion medication. The Fifth Circuit ruled in August that although the FDA’s approval of mifepristone in 2000 can remain in place, other steps that the FDA took to expand access, like allowing mifepristone to be accessed via telemedicine, must be overturned. The Fifth Circuit ruling has not gone into effect because in April, the Supreme Court issued a stay of the lower court ruling that allows mifepristone to remain on the market while the case is under review.

“The evidence overwhelmingly demonstrates that medication abortion is safe and effective, despite ongoing litigation led by anti-choice crusaders,” Sen. Cantwell said. "The FDA approved mifepristone over twenty years ago, and studies show the medication causes fewer complications than Tylenol. More than half of the abortions provided in Washington state are medication abortions. Patients must be able to access necessary health care without undue interference or harassment.”

The amicus brief was led by U.S. Senator Patty Murray (D-WA).

The members argued that the Fifth Circuit’s decision has no basis in law, poses a serious health risk to pregnant women and other individuals by limiting access to mifepristone—a safe and effective medication widely used in abortion care and miscarriage management for years—and threatens 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 Supreme Court to reject the Fifth Circuit’s decision.

“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,” the members wrote. “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 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 continued. “By disrupting FDA’s current regulation of mifepristone, the Fifth Circuit has countenanced judicial interference that erroneously substitutes a court’s judgment for FDA’s scientific determination.”

The lawmakers cite reports from doctors and journalists highlighting the increased importance of mifepristone for reproductive health care in the wake of the Dobbs v. Jackson Women’s Health Organization decision, and outline concerns that additional restrictions on access to medication abortion threaten to further increase the maternal mortality rate.

The members conclude by asking the Supreme Court to reverse the Fifth Circuit’s decision, writing: “The Fifth Circuit’s order will further restrict abortion access, exacerbating the harmful effects of existing limitations. Just as Dobbs upended abortion access and led to chaos following the decision, a disruption of mifepristone’s current conditions of use will further narrow options for care.”

Since the Supreme Court’s decision in Dobbs, 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. If left to stand, the Fifth Circuit’s order would exacerbate these adverse health outcomes by placing unnecessarily restrictions on access to the most common method of early abortion—a two-drug regimen of mifepristone and misoprostol. Moreover, restricting access to mifepristone—also used in combination with misoprostol for the management of early miscarriage—will mean fewer options for treating early pregnancy loss, which includes a spontaneous abortion, missed abortion, incomplete abortion, or inevitable abortion. These conditions can be life-threatening, including posing a risk of sepsis or loss of future pregnancy capacity, if not treated quickly.

The lawmakers’ amicus brief to the Supreme Court can be read in full HERE.

Since May 2022’s leaked draft opinion indicated the Supreme Court’s intent to overturn the reproductive care precedent established under Roe v. Wade, Sen. Cantwell has been focused on protecting abortion access and choice for women across the country. In March 2023, Sen. Cantwell joined Sen. Murray in reintroducing the Women’s Health Protection Act and hosting a roundtable discussion on the path forward to defend Americans’ reproductive rights.  

In April 2023, Sen. Cantwell joined U.S. Senator Patty Murray (D-WA) and 25 other colleagues in reintroducing the Let Doctors Provide Reproductive Health Care Act, which would ban anti-choice states from restricting or preventing health care providers from performing legal abortions. 

In May, Sen. Cantwell joined 12 Senate colleagues in reintroducing the My Body, My Data Act to protect personal reproductive health data.  

Also in May, Sen. Cantwell joined 29 Senate colleagues to introduce the Protecting Service Members and Military Families’ Access to Health Care Act, legislation that would codify the Department of Defense’s policy to help service members and their families access non-covered reproductive health care – including abortion services – regardless of the state in which they are stationed.  

In June, Sen. Cantwell joined colleagues in reintroducing the Right to Contraception Act to codify the right to contraception access established by the Supreme Court ruling Griswold v. Connecticut in 1965. Also in June, Sen. Cantwell cosponsored the Freedom to Travel for Health Care Act to ban anti-choice states from penalizing or prosecuting health care providers that offer reproductive services in states where abortion care is legal.

Earlier this month, in the days before the anniversary of the Roe v. Wade decision, Sen. Cantwell released a report describing the impact that the overturn of Roe has had on abortion providers in Washington state, including increased harassment and workloads.  The snapshot compiles stories and data from Planned Parenthood clinics in Central and Eastern Washington, the Washington State Department of Health, and the Northwest Abortion Access Fund. Together, they paint a picture of a strained reproductive care delivery system in the State of Washington: the number of abortions provided in the state rose by 23% in 2022, even as clinics struggle with staffing and harassment.

Sen. Cantwell has been actively tracking the litigation in the mifepristone case. In April 2023, Sen. Cantwell joined hundreds of her Democratic colleagues in filing amicus briefs before the U.S. Supreme Court and Fifth Circuit Court of Appeals supporting the Biden Administration’s appeals of Texas federal district court and Fifth Circuit rulings which would restrict the availability of mifepristone. In May, Sen. Cantwell joined 252 Members of Congress in submitting an amicus brief to the U.S. Court of Appeals for the Fifth Circuit in the case, urging the Court to reverse the district court’s stay on the FDA’s more than 20-year-old approval of mifepristone.