May 8th, 2023 by WCBC Radio

This week, U.S. Senators Chris Van Hollen and Ben Cardin (both D-Md.) joined their colleagues in submitting an amicus brief to the U.S. Court of Appeals for the Fifth Circuit 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. This effort was led by Senate Majority Leader Chuck Schumer (D-N.Y.) and Senators Patty Murray (D-Wash.), Bernie Sanders (I-Vt.), Dick Durbin (D-Ill.), and Richard Blumenthal (D-Conn.).  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 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 asked 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,” the lawmakers 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 cited reports from doctors and journalists highlighting the increased importance of mifepristone for reproductive health care in the wake of the Dobbs decision, and outlined concerns that additional restrictions on access to medication abortion threaten to further increase the maternal mortality rate.  The Members concluded 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.”