An amicus brief filed on behalf of over 300 leading reproductive health researchers, including ANSIRH, urges the Supreme Court of the United States to maintain access to the abortion pill mifepristone.
Today, the UCLA Law Center on Reproductive Health, Law, and Policy (CRHLP) and the law firm Paul, Weiss, Rifkind, Wharton & Garrison LLP filed an amicus brief on behalf of over 300 leading reproductive health researchers from the United States and worldwide urging the Court to reverse an appellate ruling that would severely restrict access to the abortion pill mifepristone. The brief argues that the Court should not allow the politics of abortion to obscure the clear scientific record which shows that mifepristone is extremely safe and effective.
“This is the most important case about abortion since the Supreme Court overturned Roe v. Wade,” said CRHLP Executive Director Melissa Goodman. “Medication abortion accounts for over half of all abortions across the United States and its safety has been rigorously tested. This case is a baseless and blatant attempt to restrict abortion access nationwide. The FDA carefully considered mountains of scientific evidence each time it relaxed needless restrictions on mifepristone access and the Court should not override the FDA’s thorough work.”
At issue in this case are certain modifications made by the FDA to the Risk Evaluation and Mitigation Strategy ("REMS") and labeling of mifepristone. The modifications include the recent decision by the FDA to remove the requirement for in-person dispensing and the 2016 decision to extend the gestational limit to 70 days, modify the dosing regimen, and allow healthcare providers with prescriptive authority under state law (such as nurse practitioners and physician assistants) to become certified prescribers of mifepristone. The Fifth Circuit Court of Appeals overruled the FDA’s decision, reinstating burdensome pre-2016 restrictions on mifepristone because, in the court’s view, the FDA did not have sufficient evidence that the 2016 changes that made it easier for people to access mifepristone were safe and effective. The brief argues that the FDA analyzed tens of thousands of patient experiences and relied on ample scientific evidence to conclusively demonstrate the safety and effectiveness of these changes.
CRHLP worked closely with researchers at Advancing New Standards in Reproductive Health (ANSIRH), a research program at the University of California, San Francisco (UCSF) that has conducted numerous studies on the safety and efficacy of medication abortion, to summarize the relevant studies and lead outreach to researchers who signed on to the brief.
Dr. Daniel Grossman, ANSIRH’s director and professor of obstetrics and gynecology at UCSF, said:
“The FDA has carefully reviewed study after study on mifepristone for decades and its decisions to expand how the medicine can be provided have been based on solid science. To assert otherwise is to not only throw out years of research but to make it even harder for people in the U.S. to receive abortion care—even in states where that care is legal.”
Dr. Ushma Upadhyay, an ANSIRH investigator and UCSF professor, said:
“The science is abundantly clear: mifepristone is overwhelmingly safe and effective, whether provided in-clinic, via telehealth, or in a local pharmacy. Any attempts to roll back access have nothing to do with safety and everything to do with further restricting abortion across the country.”
Read the amicus brief on mifepristone, signed by over 300 leading reproductive health researchers worldwide.
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