Debevoise & Plimpton LLP has filed an amicus curiae brief in the Fourth Circuit Court of Appeals on behalf of the nation’s leading medical societies in an effort to protect access to mifepristone, a drug commonly used in medication abortion and miscarriage care. North Carolina has imposed several barriers to mifepristone access which the Food and Drug Administration (“FDA”) already considered and rejected as unnecessary for mifepristone’s safe use. For example, despite the FDA’s evidence-based determination that mifepristone use is no safer when prescribed by a certified physician than it is when prescribed by a certified non-physician clinician, North Carolina’s law implements a requirement that only physicians may prescribe mifepristone. North Carolina also seeks to require in-person pre-prescription patient evaluation, in addition to requiring in-person prescribing, dispensing, administering, and follow-up, as well as burdensome non-adverse event reporting for prescribing physicians.
The medical societies’ amicus brief supports Plaintiff-Appellee Dr. Amy Bryant, M.D., a North Carolina physician and abortion provider. Dr. Bryant filed the original underlying federal complaint in the Middle District of North Carolina against certain state officials and lawmakers, arguing that North Carolina’s restrictions on mifepristone were preempted by the FDA’s more lenient regulations of the drug. The District Court ruled that some of the challenged restrictions are preempted because states cannot enact laws that conflict with FDA decisions, while others are not preempted because they focus on “general patient health and welfare and informed consent,” rather than safety of mifepristone itself. Both sides appealed the ruling.
Along with Plaintiff-Appellee Dr. Bryant, amici medical societies request that the Fourth Circuit reverse the judgment of the District Court to the extent it held that North Carolina’s restrictions governing medication abortion are not preempted by federal law, and uphold the judgment of the District Court insofar as it held that the restrictions are preempted, to preserve access to mifepristone under the terms currently approved by FDA. The brief underscores that mifepristone is an essential part of reproductive healthcare, that it is safe and effective, and that additional restrictions surrounding its use are neither medically necessary nor scientifically sound. The brief makes clear that the FDA’s decisions to remove identical restrictions on mifepristone—or to not impose them in the first place—were firmly based on “hundreds of studies and decades of evidence.” North Carolina’s restrictions are therefore unwarranted and have no tie to patient care or health outcomes. Instead, the restrictions are a “thinly-veiled attempt to limit access to a demonstrably safe medication because certain legislators oppose how it is used.”
Limiting access to mifepristone impedes access to quality reproductive health care more generally and will only exacerbate the risks already associated with pregnancy and childbirth. While restricting access to mifepristone endangers anyone who is pregnant, the consequences will be most severe for populations who are already poorly served by the maternal health system, including people of color as well as low-income and rural patients. North Carolina’s law, in short, seeks to both undermine the nation’s longstanding drug approval system and improperly targets mifepristone because of personal opposition to abortion care not rooted in science, medical ethics, or patient care.
The brief was filed on behalf of American College of Obstetricians and Gynecologists; Society for Maternal-Fetal Medicine; Society of Family Planning; American Academy of Family Physicians; American Academy of Nursing; American College of Medical Genetics and Genomics; American College of Physicians; American College of Preventative Medicine; American Gynecological and Obstetrical Society; American Medical Women’s Association; American Society for Reproductive Medicine; Council of University Chairs of Obstetrics & Gynecology; North American Society for Pediatric Adolescent Gynecology; Society of General Internal Medicine; and Society of Gynecologic Oncology.
The Debevoise team is led by litigation partner Shannon Rose Selden and associates Adam Aukland-Peck and Nicole Marton and includes associates Isabelle Canaan, Cara Ortiz, Zoe Jacoby and Kaitlyn McGill and law clerk Alexandra McDevitt.