Mifepristone restrictions in U.S. and around the world harm women

Tuesday, February 28, 2017

woman in pharmacy in Ethiopia

The overregulation of mifepristone in the United States is not only medically unnecessary, but also harmful to women seeking medical abortion, asserts a commentary published last week in the New England Journal of Medicine. In the developing countries where Ipas works, similar harm results when women can’t access mifepristone due to regulations or high cost and are thereby deprived of the highest-quality medical abortion care.

“A regimen of mifepristone combined with misoprostol is the gold standard for medical abortion care, according to the World Health Organization,” says Ipas’s Emily Jackson, MD, a senior clinical consultant. “In developing countries across Africa, Asia and Latin America, we work with health systems and clinicians who must provide a misoprostol-only regimen—which has a lower efficacy rate—because national regulations either prohibit the use of mifepristone or cause it to be prohibitively expensive.”

Although 16 years of data in the United States shows that mifepristone, under the brand name Mifeprex®, is a safe and effective abortion method, FDA regulations continue to require onerous stipulations that are unlike what is required to provide most medication. All providers who offer mifepristone must complete an unnecessary certification process, women taking mifepristone must receive an unnecessary Medication Guide and sign an FDA-approved Patient Agreement, and mifepristone can only be dispensed to patients in clinics, medical offices and hospitals by or under the supervision of a certified prescriber—meaning that other clinicians cannot prescribe it and retail pharmacies cannot sell it.

“The restrictions on mifepristone are a shameful example of overregulation run amok—and they’re harming women’s health,” says Beverly Winikoff, MD, MPH, President of Gynuity Health Projects and one of the authors of the commentary. “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.”

Similarly, countries around the world should heed this expert advice, Jackson says. “Making mifepristone available and affordable is an important step toward ensuring top-quality medical abortion care for women everywhere.”