Wyden Leads Congressional Democrats in Fifth Circuit Fight to Protect Mifepristone Access, Women’s Health Care

Wyden Leads Congressional Democrats in Fifth Circuit Fight to Protect Mifepristone Access, Women's Health Care

More than 250 House and Senate Democrats filed an amicus brief to the Fifth Circuit arguing that mifepristone has undergone a rigorous FDA approval process and has repeatedly been found to be safe and effective.

Washington, D.C. - U.S. Senator Ron Wyden said today he is leading Senate and House Democrats in filing an amicus brief pushing back against Louisiana's attempt to reinstate the in-person dispensing requirement for mifepristone that would restrict critical access for patients in Oregon and across the nation.

Following the Supreme Court's stay of the Fifth Circuit Court of Appeals' nationwide ban on telehealth access to mifepristone, Louisiana v. Food and Drug Administration (FDA) went back to the Fifth Circuit. Louisiana is seeking a ruling that would force the FDA to reinstate the in-person dispensing requirement nationwide for mifepristone-a safe and effective abortion medication that has been FDA-approved since 2000. This medically unnecessary move would end patient access to mifepristone through telemedicine, the method through which more than 1 in 4 women receive their care across the country. The ruling would also remove patients' ability to get mifepristone directly from their pharmacy, forcing them to find a provider that dispenses the medication.

"For more than a quarter century, FDA has repeatedly and consistently affirmed that mifepristone is safe. Over seven million patients in the U.S. have safely used mifepristone. And as with other drugs, FDA continues to monitor the post-marketing safety data on mifepristone-data confirming that mifepristone is safe without regard to how it is dispensed," the members wrote.

The lawmakers emphasized that the in-person dispensing requirement was eliminated in 2021, prior to the Dobbs v. Jackson Women's Health Organization decision of 2022, and not in response to the Supreme Court's decision.

"The in-person dispensing requirement was first suspended by a court in 2020 and later eliminated altogether by the FDA in 2021, before Dobbs came down," the members wrote in their brief. "Louisiana knows these facts but continues to make this spurious claim in its attempt to reimpose an unnecessary burden on all Americans, even residents of states that protect abortion. Decades after FDA's initial approval of mifepristone and years after the in-person dispensing requirement was eliminated, Louisiana now seeks to re-impose this onerous nationwide restriction on all Americans."

"Granting such relief would undermine the science-based statutory framework Congress requires and threatens patient access to reproductive health care," the lawmakers continued. "As has been well documented, many Americans in states where abortion is legal live far from any reproductive health care provider. Reinstating an in-person dispensing requirement for mifepristone exacerbates an already significant reproductive health crisis by limiting access to the most common method of early abortion."

Louisiana's request for a stay of FDA's 2023 rule would result in the reinstatement of the in-person dispensing requirement for mifepristone nationwide-and if granted, would have no basis in law, and would threaten the congressionally-mandated evidence-based process for drug regulation. The court overturning this decision not only limits who can receive this vital and life-saving medication, putting lives at risk, but it also undermines the longstanding, congressionally mandated, and evidence-based decision-making process at the FDA. The lawmakers argue that the Fifth Circuit should deny the stay, protecting telehealth and pharmacy access to mifepristone.

Wyden has been a strong advocate for mifepristone and preserving access to essential health care. In 1990, Wyden chaired the first-ever congressional hearing on mifepristone, launching decades of federal advocacy to ensure access to the medication remained grounded in scientific evidence. Wyden actively fought early FDA import alerts that restricted research on the drug and introduced legislation to lift those barriers prior to its ultimate federal approval in 2000. Following recent legal rulings aimed at restricting access, Wyden delivered Senate floor remarks calling on executive agencies to protect nationwide availability and defend the drug's proven safety record. He has continued to lead congressional colleagues in filing amicus briefs to uphold the FDA's evidence-based regulatory authority and preserve access to reproductive health care across the country.

The amicus brief was led by Wyden, U.S. Senator Patty Murray, D-Wash., Senate Democratic Leader Chuck Schumer, D-N.Y., House Democratic Leader Hakeem Jeffries, D-N.Y., and U.S. Representatives Katherine Clark, D-Mass., Frank Pallone Jr., D-N.J., Diana DeGette, D-Colo., Jamie Raskin, D-Md., and Ayanna Pressley, D-Mass. The brief was signed by all 47 Democratic U.S. Senators and 212 U.S. Representatives.

The full amicus brief is here.