Saturday, April 15, 2023
WASHINGTON (KTVZ) — Senators Ron Wyden and Jeff Merkley and Reps. Earl Blumenauer, Suzanne Bonamici, Val Hoyle, and Andrea Salinas this week submitted an amicus brief with colleagues in support of the Biden administration’s appeal of U.S. District Court judge Matthew J. Kacsmaryk’s ruling last week that suspends the Food and Drug Administration’s more than 20-year-old approval of mifepristone.
The Trump-appointed federal judge’s ruling threatens access to mifepristone for patients in Oregon and nationwide, as well as FDA’s congressionally-mandated authority and drug approval process.
The new amicus brief underscored that the district court ruling has no basis in law; risks denying patients in Oregon 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, the lawmakers asked the court to stay the district court’s order.
“The district court appears to have second-guessed FDA’s scientific determinations with cherry-picked anecdotes and studies, and on that basis, imposed a remedy that could significantly upend the status quo,” the lawmakers wrote in their brief to the U.S. Court of Appeals for the Fifth Circuit in the case of Alliance for Hippocratic Medicine v. FDA.
If the district court ruling were left to stand and were to go into effect, the members stressed that not only could patients in Oregon and nationwide 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 at risk, threatening patients’ access to all manner of other medications.
“[T]he district court’s misguided stay under Section 705 of the Administrative Procedure Act will reduce access to abortion, exacerbating an already significant reproductive health crisis,” the lawmakers continued in their brief. “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.”
“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 stated.
The members also explained 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 concluded their brief by asking the Fifth Circuit to stay the decision, “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 lawmakers’ amicus brief is here
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