Experts Call for an End to Overregulation of Mifepristone

In a new commentary published in the New England Journal of Medicine, a multi-disciplinary group of clinicians and public health and legal experts highlight how the over-regulation of mifepristone is not only medically unnecessary, but in fact harmful to women seeking medical abortion. Dr. Elizabeth Raymond, Senior Medical Associate and lead author, and Dr. Beverly Winikoff, President of Gynuity Health Projects, were among the experts making this compelling case. Read full press release below.

PRESS RELEASE
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Public Health Experts Call for an End to Overregulation of Mifepristone

Commentary in New England Journal of Medicine asserts that FDA restrictions constitute an undue burden to patients who seek medical abortion

(February 22, 2017 New York, NY)— Today, in a new commentary published in the New England Journal of Medicine, a multi-disciplinary group of clinicians and public health and legal experts highlight how the overregulation of mifepristone is not only medically unnecessary, but in fact harmful to women seeking medical abortion.

In “Sixteen Years of Overregulation: Time to Unburden Mifeprex®,” researchers criticize the FDA regulation mechanism known as a “REMS” (Risk Evaluation and Mitigation Strategy). The REMS restrictions, implemented when mifepristone was first introduced in the U.S. in 2000, currently have stipulations that are unlike what is required to provide most medication:

• mifepristone can only be dispensed to patients in clinics, medical offices, and hospitals by or under the supervision of a certified prescriber; it may not be prescribed by clinicians or sold in retail or mail-order pharmacies;
• all providers who offer mifepristone must complete an unnecessary certification process, attesting to skills that are common to all women’s health providers; and
• each woman taking mifepristone must receive a Medication Guide and sign an FDA-approved Patient Agreement—an unnecessary requirement since providers already give women the information they need.

As the commentary explains, the REMS restrictions on mifepristone are inconsistent with how most drugs are regulated. Stringent REMS restrictions are only used for a small number of drugs, typically those with either a limited safety record or serious risk of complication or abuse. According to a 2016 statement by the American Congress of Obstetricians and Gynecologists, evidence regarding the safety of mifepristone over the past 16 years of use in the United States provides a compelling argument for the removal or substantial modification of the REMS restrictions.

“It’s unconscionable that the REMS restrictions remain after 16 years of data showing mifepristone is an exceedingly safe and effective abortion method,” said Beverly Winikoff, M.D., M.P.H., President of Gynuity Health Projects. Winikoff continued, “The restrictions on mifepristone are a shameful example of overregulation run amok—and they’re harming women’s health. Women and their health providers shouldn’t have to jump through hoops to get a medication that’s been safely and effectively used in this country for a decade and a half.”

Moreover, the REMS place medically unnecessary burdens on patients and providers, and keep mifepristone from being prescribed by clinicians or sold in pharmacies alongside hundreds of other prescription medications. Overregulation means that fewer providers offer mifepristone and fewer women have access to this safe and effective option for ending a pregnancy. This burden is especially heavy on poor and rural women.

“We know based on 16 years of experience and study that mifepristone is a safe and effective medication,” said Elizabeth Raymond, MD, MPH, Senior Medical Associate with Gynuity Health Projects. “The mifepristone REMS restrictions are irrelevant to making it safer, but they do impede women's access to the drug. The FDA is required by law to avoid unnecessarily burdening patients' access to health care. It should fulfil that requirement by lifting this REMS.”

Removal of the REMS would foster opportunities for innovation in service delivery and important opportunities to increase access to safe abortion. Medical abortion has potential to fill in gaps in abortion access: it doesn’t require the infrastructure or facilities that other abortion procedures require and could be better integrated into the U.S. health system by expanding who provides it, how, and when. Removing the REMS would also help make medical abortion through telemedicine possible for some women in underserved areas.

Background:
In 2016, the label for mifepristone—which has been used safely and effectively to end pregnancy in the U.S. for 16 years—was updated to more closely align with current medical practice and evidence. Researchers and medical experts have criticized the label changes for not going far enough, given the excellent safety and efficacy record of the drug.

The Mifeprex REMS Study Group:

• Elizabeth G. Raymond, M.D., M.P.H., Gynuity Health Projects, New York, NY
• Kelly Blanchard, M.Sc., Ibis Reproductive Health, Cambridge, MA
• Paul D. Blumenthal, M.D., M.P.H., Division of Family Planning Services and Research, Department of Obstetrics and Gynecology, Stanford University School of Medicine, Stanford, CA
• Kelly Cleland, M.P.A., M.P.H., Office of Population Research, Princeton University, Princeton, NJ
• Angel M. Foster, D.Phil., M.D., A.M., Faculty of Health Sciences, University of Ottawa, Ottawa, Canada
• Marji Gold, M.D., Albert Einstein College of Medicine, Bronx, NY
• Daniel Grossman, M.D., Advancing New Standards in Reproductive Health (ANSIRH), Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, CA
• Mary K. Pendergast, J.D., LL.M., Pendergast Consulting, Washington DC
• Carolyn Westhoff, M.D., M.Sc., Columbia University, New York, NY
• Beverly Winikoff, M.D., M.P.H., Gynuity Health Projects, New York, NY

Gynuity Health Projects
Gynuity Health Projects is a research and technical assistance organization dedicated to the idea that all people should have access to the fruits of medical science and technology development. For more information, go to www.gynuity.org.