253 Members of Congress ask the Fifth Circuit to reverse Texas district court’s ruling in its entirety

Tuesday, May 2, 2023

Washington, D.C. – U.S. Senators Ron Wyden and Jeff Merkley, along with 253 members of Congress, submitted an amicus brief to the U.S. Court of Appeals for the Fifth Circuit today in the case of Alliance for Hippocratic Medicine v. FDA, urging the Court to reverse the district court’s stay on the FDA’s more than 20-year-old approval of mifepristone.

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 members argued that the district court’s decision has no basis in law, poses a serious health risk to pregnant women and other individuals by 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 they said the decision —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 Fifth Circuit to reverse the district court’s order.

“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,” Wyden, Merkley andcolleagues 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 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,” the lawmakers continued. “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 cite reports from doctors and journalists highlighting the increased importance of mifepristone for reproductive health care in the wake of the Dobbs 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 Fifth Circuit to reverse the district court’s decision, writing: “[t]he district court’s order not only misapplies the law but also threatens to harm 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.”

 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 hurt 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 district court’s order would worsen these adverse health outcomes by eliminating access to the most common method of early abortion—a two-drug regimen of mifepristone and misoprostol.  Moreover, eliminating 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—conditions that 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 Fifth Circuit is HERE.

A web version of this release is here.