HARTFORD — U.S. Senators Chris Murphy (D-Conn.) and Richard Blumenthal (D-Conn.) on Wednesday led 263 Members of Congress in submitting an amicus brief to the U.S. Supreme Court in the case of Alliance for Hippocratic Medicine v. FDA, urging the Supreme Court to reverse a stay from Texas District Court that would override the Food and Drug Administration (FDA)’s scientific judgment and dramatically curtail access to mifepristone—a safe and effective medication abortion drug that was approved by the FDA in 2000 and is used in more than half of all abortions in the U.S.

At issue in the case are evidence-based regulatory actions the FDA took in 2016 and 2021 that broadened access to mifepristone, including extending the time frame for mifepristone use during the early stages of pregnancy and removing onerous in-person dispensing requirements for mifepristone.

If the Supreme Court affirms the Fifth Circuit’s decision upholding the district court’s stay of the FDA’s 2016 and 2021 actions, it would be effectively rolling back the clock and overriding FDA’s robust scientific approvals process—with immediate and sweeping consequences in every state on the ability of patients to access mifepristone for safe abortion care and miscarriage management.  

In the new amicus brief, the Members of Congress underscore that both the appeals court and the district court rulings threaten the congressionally mandated drug approval process, and pose a serious health risk to pregnant individuals by making safe abortion care more difficult to access—when access has already been seriously eroded in the aftermath of the Dobbs v. Jackson Women’s Health Organization decision that overturned Roe v. Wade.

“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.

The lawmakers go on to make clear the Fifth Circuit’s decision to maintain Judge Kacsmaryk’s stay of mifepristone’s current, FDA-approved conditions of use disrupts longstanding statutory framework.

“Decades after FDA’s initial approval—yet somehow in an emergency posture—the district court and the Fifth Circuit 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,” the lawmakers wrote.

If the Supreme Court upholds the Fifth Circuit’s ruling, the Members stress 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 make clear 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 point 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 conclude 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.

The amicus brief was led by Senators Schumer, Murray, Sanders, Durbin and Blumenthal, and joined by 45 of their Democratic colleagues including Senators Baldwin, Bennet, Booker, Brown, Cantwell, Cardin, Carper, Casey Jr., Coons, Cortez Masto, Duckworth, Feinstein, 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, 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.

 

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