Durbin, Duckworth Join Democrats To File Amicus Brief Urging Supreme Court To Prevent Dangerous Ruling From Restricting Access To Mifepristone Nationwide & Upending FDA Approval Process

Press Release

"[T]he district court appears to have second-guessed FDA's expert determinations with cherry-picked anecdotes and studies, and on that basis, imposed a remedy that could significantly upend the status quo. [I]t is an extraordinary and unprecedented step for the district court to invalidate on substantive grounds--and over FDA's objection--a longstanding approval for a drug with a history of safe and effective use. This Court should stay the entirety of that aberrant decision pending appellate review.

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Decades after FDA's initial approval--yet somehow in an emergency posture--the district court intruded into FDA's drug approval process, casting a shadow of uncertainty over its decisions. The perils of this unwarranted judicial intervention into science-based determinations can hardly be overstated. Researchers, health care providers, and patients suffering from a range of medical conditions rely on the integrity and stability of the rigorous science-based drug approval process. The specter of precipitous judicial meddling therefore threatens access to life-improving and lifesaving drugs.

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The consequences of the Fifth Circuit's decision 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. By permitting the district court to disrupt FDA's current regulation of mifepristone, the Fifth Circuit has countenanced judicial interference that erroneously substitutes the district court's judgment for FDA's scientific determination.

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. Moreover, the prospect of courts second-guessing FDA's rigorous drug safety and effectiveness determinations will disrupt industry expectations and could chill pharmaceutical research and development.

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For the last century, a statutory scheme designed by Congress has assured the safety and effectiveness of the drugs available in the United States. At its core resides the application of scientific standards by agency experts. Here, 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.

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Although the district court styled its relief as "less drastic,' it is not apparent that its consequences are less disruptive than those of a mandatory injunction. 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 had baleful effects on 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. The Fifth Circuit's order would exacerbate these adverse health outcomes by limiting access to the most common method of early abortion--a two drug regimen of mifepristone and misoprostol.

Therefore, 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 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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