EXPERTS ADVISORY

University of Michigan experts are available to discuss the upcoming Supreme Court case that will determine access to the abortion drug mifepristone. The court’s decision will impact abortion access even in states that allow abortion, and could also have big implications for the Food and Drug Administration’s regulatory authority over drugs.

Vicki Ellingrod, dean of the College of Pharmacy and the John Gideon Searle Professor of Translational Pharmacy, has expertise in mental health pharmacotherapy and the clinical trials process that informs the decisions made by the FDA. Consumers and patients, she says, should be concerned about political efforts that threaten the agency’s mission of approving safe, effective drugs.

“The FDA’s approval of medications, biological products and medical devices is steeped in data and science and includes the execution of rigorous safety testing through clinical trials and proof of efficacy,” Ellingrod said. “Ultimately, the FDA grants approval when there is clear evidence that benefits outweigh risks.

“Mifepristone is no exception. It has safely been used by millions of women. Any challenge to the FDA’s approval that isn’t about safety or effectiveness undermines an agency responsible for keeping us from returning to the not-so-distant past where medications were not required to show safety or efficacy and resulted in significant morbidity and mortality.”

Contact: vellingr@med.umich.edu

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Paula Lantz, the James B. Hudak Professor of Health Policy at the Ford School of Public Policy, is a social demographer/social epidemiologist who studies the role of public policy in improving population health and reducing social disparities in health. She is engaged in research regarding abortion policy, housing policy and on how COVID-19 continues to exacerbate existing social, economic and health inequities in the U.S.

“The Alliance for Hippocratic Medicine maintains the core legal issue is that the FDA ignored evidence regarding the risks of mifepristone in its regulatory decisions in an arbitrary and capricious manner,” Lantz said. “The truth is, however, that this SCOTUS case is about the politics of abortion and the misrepresentation of sloppy science.

“The three studies raising concerns about the safety of mifepristone that informed lower court decisions have since been shown to be flawed, misleading and biased, and were all retracted. Over 100 other studies across multiple countries demonstrate that mifepristone is safe in early pregnancy including when prescribed via telemedicine.”

Contact: plantz@umich.edu

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Lee Roosevelt is a clinical associate professor at the School of Nursing and a practicing nurse-midwife with more than 20 years of research and practice experience in sexual and reproductive health care.

“Mifepristone is an essential medication for abortion and miscarriage management,” she said. “The medication was developed in 1980 and has been approved by the FDA in the United States for almost 25 years. The medication has been used by over 5 million people in the United States. There is extensive data pointing to its safety and necessity for comprehensive, evidence-based health care.

“A ban on the medication would not only impact people choosing elective abortions, but would have a negative impact on the way that we safely treat miscarriages. Additionally, a ban would worsen already existing health inequities and health disparities. This case, as well as the Dobbs decision, is another example of the slow and deliberate deterioration of the rights to personal privacy and autonomous health care decision making that will have widespread impact outside the arena of abortion care.”

Contact: morgaine@umich.edu

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Leah Litman, professor at the Law School, teaches and writes on constitutional law and federal courts. Her research examines unidentified and implicit values that are used to structure the legal system, the federal court, and the legal profession. She has written extensively and been widely cited on reproductive freedom and the law.

Contact: lmlitman@umich.edu

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Richard Friedman, professor at the Law School, is an expert on evidence and U.S. Supreme Court history. He led an online teach-out on reproductive rights and the legal, political and medical ramifications of the Supreme Court’s decision to overturn Roe v. Wade.

Contact: rdfrdman@umich.edu

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Susan Ernst is chief of gynecology and sexual health at the University Health Service, associate professor of obstetrics and gynecology at Michigan Medicine, and medical adviser for gender-based misconduct for the U-M Equity, Civil Rights, & Title IX office. She served as the campus lead for U-M’s Reproductive Rights Task Force and as a member of the American College Health Association’s Reproductive Rights Task Force. She is a leading advocate for reproductive health care for women with disabilities and for improving sexual assault services on campus.