CONGRESSIONAL DEMOCRATS FILE AMICUS BRIEF URGING FIFTH CIRCUIT TO REVERSE TEXAS DISTRICT COURT'S RULING ON MIFEPRISTONE

Press Release

"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,"

"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,"

"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."

"[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."

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