The Guttmacher Institute and several of its senior social scientists have joined two powerful amicus briefs that were submitted to the US Supreme Court on January 30, calling on the Court to reverse the Fifth Circuit Court of Appeals’ dangerous decision to limit access to medication abortion and uphold the FDA’s long-standing approval of mifepristone without imposing medically unnecessary restrictions.
“The facts couldn't be more straightforward: Mifepristone is safe, effective and essential. Limiting access to medication abortion—which is used in over half of all US abortions—would only deepen the crisis that dramatically escalated when Roe was overturned almost two years ago,” says Kelly Baden, Guttmacher’s Vice President for Public Policy. “In the face of relentless attacks on abortion rights, the Supreme Court has only one reasonable option—honor the FDA approval of mifepristone and preserve access to medication abortion without any medically unnecessary restrictions.”
In one brief, the Institute joins more than 200 other reproductive health, rights and justice groups in making the case for why the Supreme Court should overturn the Fifth Circuit’s decision, while also addressing the broader social, economic and health consequences of revoking access to mifepristone, one of two drugs used in the most common US medication abortion regimen.
“Restrictions on mifepristone would have widespread detrimental consequences. The Fifth Circuit’s decision reimposes a burdensome in-person dispensing requirement and narrows the types of medical professionals who can become certified prescribers. As a result of these restrictions, even people in states where abortion remains legal and protected could find themselves unable to timely access mifepristone, imperiling access to abortion and jeopardizing the health and autonomy of those denied care. Clinics and providers—including several amici—could find themselves unable to effectively provide competent and much-needed medical care.
Far from protecting patient health, the Fifth Circuit’s decision will have severe and damaging consequences unsupported by law or science. The decision should be reversed.”
In the other brief, seven of Guttmacher’s leading research experts partnered with more than 300 other reproductive health researchers in the United States and worldwide to review the decades of scientific evidence on mifepristone’s safety and effectiveness in support of the FDA’s evidence-based decisions that granted and expanded access to medication abortion.
“This Court should not allow the politics of abortion to obscure the clear, abundant, and plainly sufficient scientific record supporting FDA’s decision-making in this case. In approving certain modifications to mifepristone’s Risk Evaluation and Mitigation Strategy (“REMS”) and labeling in 2016 and 2021, FDA reviewed and relied on extensive scientific evidence conclusively showing the safety and effectiveness of the changes....
It is clear that the evidentiary support for FDA’s 2016 and 2021 decisions far exceeded the statutory requirements.... Pursuant to the statutory requirements, FDA regularly approves drugs supported by only one clinical study. In this case, the record supporting the 2016 and 2021 changes to mifepristone’s REMS and labeling demonstrates that FDA not only met its statutory requirements, but also went well beyond them....
The studies leave no doubt as to the safety and effectiveness of mifepristone’s modified REMS and labeling. Consistent with this overwhelming evidence, this Court should reverse the Fifth Circuit’s decision.”
About the Guttmacher Institute
The Guttmacher Institute is a leading research and policy organization committed to advancing sexual and reproductive health and rights worldwide. The Institute generates data and analysis to defend and advance people’s ability to access the full range of sexual and reproductive health care—including safe, legal and affordable abortion care—with a particular focus on addressing historical and ongoing oppressions due to race, gender, sexuality, income, age or immigration status.