February 28, 2017

News |

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

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.”

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