ICYMI: Murray Leads Congressional Democrats in Amicus Brief Urging SCOTUS to Reverse Dangerous Ruling That Would Restrict Access to Mifepristone Nationwide & Upend FDA Approval Process

Letter

“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 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,” the lawmakers wrote. “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.

In the aftermath of this 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 dangerously affected health outcomes for pregnant individuals. Some individuals report being forced to forgo cancer treatment, while others report developing sepsis, being left bleeding for days after an incomplete miscarriage, enduring the risk of rupture due to ectopic pregnancy or being forced to continue carrying a fetus diagnosed with a lethal fetal anomaly such as anencephaly. For some individuals, pregnancy is a life-threatening condition, regardless of their desire to carry their fetus to term. The Fifth Circuit’s order will exacerbate these adverse health outcomes by limiting access to the most common method of early abortion. It will also create additional confusion on top of the post-Dobbs uncertainty surrounding the legality of different forms of reproductive health care.

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...medication abortion using mifepristone is an important means for vulnerable groups to access medical care without having to bear the cost of long-distance travel to find access to procedural abortion and the difficulties associated with getting time off or finding child care,” making clear that “just as Dobbs upended abortion access and led to chaos following the decision, a disruption of mifepristone’s current conditions of use will further narrow options for care.”

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