In new amicus brief lawmakers make clear: Friday’s ruling has no basis in law, poses serious health risks to pregnant patients, and threatens FDA’s Congressionally-mandated drug approval process
Reno, Nev. – Senator Catherine Cortez Masto (D-Nev.) joined Senators Schumer, Murray, Durbin, Sanders, and Blumenthal and 240 total Members of Congress—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, in support of the Biden administration’s appeal of federal district court’s ruling that suspends the Food and Drug Administration’s (FDA) more than 20-year-old approval of the abortion pill mifepristone.
In the new amicus brief, the Members of Congress underscore that the district court ruling has no basis in law, 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, 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. 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 the lawmakers in their brief.
If the district court ruling were left to stand and were to go into effect, the Members 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.
“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,” the lawmakers state.
The Members 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.
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.”
The full draft of the brief can be found here.
Senator Cortez Masto has been fierce advocate for women’s reproductive rights. After the Supreme Court overturned Roe v. Wade, Senator Cortez Masto introduced the Freedom to Travel for Health Care Act of 2022 to ensure legal protections for women traveling across state lines to receive reproductive care. She has urged the Federal Trade Commission (FTC) to protect the data privacy of women seeking reproductive health care and introduced legislation to make sure women across the country have access to affordable over-the-counter birth control. Just last month she took on one of the nation’s biggest pharmaceutical wholesalers to ensure Nevadans can access the abortion pill in retail pharmacies, including Walgreens.
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