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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

New data shows medication abortion accounted for 63 percent of abortions in the U.S. last year—up 10 percent since 2020

VIDEO: With oral arguments in FDA v. Alliance for Hippocratic Medicine before the Supreme Court on Tuesday, Democratic Senators uplift their amicus brief urging the Court to reverse the Fifth Circuit ruling that could dramatically curtail access to mifepristone nationwide

Case threatens to worsen existing reproductive health care crisis and undermine FDA’s Congressionally-mandated drug approval process, putting at risk patients’ access to all manner of other medications

Washington, D.C. — ICYMI, U.S. Senator Patty Murray (D-WA) led 263 Members of Congress earlier this year in submitting an amicus brief to the U.S. Supreme Court in a case the Court will hear Tuesday—Alliance for Hippocratic Medicine v. FDA—that concerns the fate of mifepristone, a safe and effective medication abortion drug that was approved by the U.S. Food and Drug Administration (FDA) in 2000 and is also critical for miscarriage care. Medication abortion using mifepristone accounted for 63 percent of abortions in the U.S. last year according to new data, marking a 10 percent jump in the use of medication abortion since 2020.

The case before the Supreme Court on Tuesday threatens to override the FDA’s scientific judgment and dramatically curtail access to mifepristone in all 50 states.

At issue before the Court is whether to uphold or reverse a decision from the Fifth Circuit Court of Appeals that would impose severe limitations on the availability of mifepristone nationwide. If the Supreme Court upholds the Fifth Circuit’s decision, it would immediately reinstate significant and medically unnecessary restrictions on mifepristone—reversing moves by the FDA in 2016 and 2021 to expand access—and seriously limit people’s ability to access mifepristone in every single state, including by prohibiting people from receiving mifepristone in the mail. This would cause immense chaos and worsen the already dire landscape for reproductive health care in post-Dobbs America—where women in 21 states are subject to abortion bans, and one in three women of reproductive age cannot access abortion in their home state.

In addition, such a ruling would undermine—and could upend—the FDA’s rigorous drug approval process for other critical medications, everything from cancer medication to Alzheimer treatments. 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 their amicus brief in January, 263 Members of Congress made clear the lower court rulings threaten the congressionally-mandated drug approval process and pose a serious health risk women across America by making safe abortion care even more difficult to access.

“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 Members wrote.

If the Supreme Court upholds the Fifth Circuit’s ruling, the Members stressed that not only could patients’ access in every state to the most common form of abortion care—and an important drug used in miscarriage management—be severely limited, 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.

“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.”

The lawmakers also made clear in their brief that invalidating the FDA’s current approach to regulating mifepristone would reduce access to abortion care—especially for low-income individuals and people of color—exacerbating the reproductive health care crisis the Dobbs decision unleashed:

“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 Members wrote. “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.”

The lawmakers also pointed out that “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.” The lawmakers concluded their amicus brief by asking the Supreme Court to reverse the Fifth Circuit’s affirmance of the district court’s stay of the FDA’s 2016 and 2021 regulatory actions.

In the Senate, the amicus brief was signed by 50 U.S. Senators: Schumer, Murray, Sanders, Durbin, Blumenthal, Baldwin, Bennet, Booker, Brown, Butler, Cantwell, Cardin, Carper, Casey Jr., Coons, Cortez Masto, Duckworth, Fetterman, Gillibrand, Hassan, Heinrich, Hickenlooper, Hirono, Kaine, Kelly, King, Klobuchar, Luján, Markey, Menendez, Merkley, Murphy, Ossoff, Padilla, Peters, Reed, Rosen, Schatz, Shaheen, Sinema, Smith, Stabenow, Tester, Van Hollen, Warner, Warnock, Warren, Welch, Whitehouse, and Wyden. In the House, the brief was signed by 213 U.S. Representatives.

The lawmakers’ amicus brief to the Supreme Court can be read in full HERE.

Senator Murray has been leading the response to this dangerous lawsuit in Congress from the beginning. Following Judge Kacsmaryk’s decision in Alliance for Hippocratic Medicine v. FDA in the federal district court in Texas, Murray emphatically denounced the ruling in a press call the very next morning with Leader Schumer, helped lead her colleagues in filing an amicus brief before the Fifth Circuit urging a stay of Kacsmaryk’s ruling, and slammed the Fifth Circuit’s April 12th decision not to block the district court’s order and reinstate medically unnecessary restrictions on mifepristone while litigation continues. Murray helped lead her colleagues in filing an amicus brief encouraging the Supreme Court to stay the lower court ruling, which the Court did later in April—allowing mifepristone to remain on the market under its existing FDA approval while the merits of the case are under review.

When the Fifth Circuit ruled in August to reinstate burdensome restrictions on mifepristone that the FDA lifted years earlier, Murray responded forcefully and led 257 members—50 Senators and 207 Members of the U.S. House of Representatives—in filing an amicus brief  in October urging the Supreme Court to grant certiorari in the case, arguing that FDA’s current approach to regulating mifepristone must be upheld. In December, Murray responded to the Supreme Court agreeing to take up this case.

Senator Murray has been repeatedly warning about the tremendous harm this lawsuit could inflict on women and patients in all 50 states and has been leading the fight in Congress to protect Americans’ ability to get medication abortion. She pushed to expand access to mifepristone as COVID-19 first spread across the U.S. and blocked Republicans’ attempts to curb access to it in the middle of the pandemic. Senator Murray applauded FDA’s removal of burdensome barriers to mifepristone and has long underscored that access to medications like mifepristone, which has a strong track record of safety and effectiveness, should be based on science—not politics.

Senator Murray has always fought to make reproductive health care more accessible and affordable for women everywhere–beating back countless Republican attempts to defund Planned Parenthood and other family planning services over the course of her career, and she is widely credited with successfully pushing the Bush administration to follow the science and make Plan B available over the counter.

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