Updated FDA Label Better Reflects Evidence-Based Medicine, Could Expand Access to Medication Abortion

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Updated FDA Label Better Reflects Evidence-Based Medicine, Could Expand Access to Medication Abortion

Change aligns Mifepristone label with current best medical practice and more than 15 years of scientific evidence

WASHINGTON - The U.S. Food and Drug Administration (FDA) has announced it intends to approve a change to the label for Mifepristone (known as Mifeprex®), a drug used to end an early pregnancy, in order to better reflect current medical practice and years of scientific evidence.

This change has the potential to increase access to this safe option in the earliest weeks of pregnancy in states where medication abortion methods are subject to politically motivated restrictions that have forced physicians to prescribe Mifepristone according to the outdated, inferior, and less effective FDA label originally approved in 2000.    

The Center for Reproductive Rights is currently working with our partners and health care providers in states across the country to determine the impact on women seeking medication abortion in light of this announcement.     

Said Nancy Northup, president and CEO of the Center for Reproductive Rights:

"The FDA’s approval of a label reflecting a more updated, evidence-based protocol for medication abortion has the potential to expand women's options for safely ending a pregnancy in the earliest weeks.

"This label change underscores just how medically unnecessary and politically motivated restrictions on medication abortion in states like Texas and Oklahoma truly are—and demonstrates the lengths politicians will go to single out reproductive health care to restrict women’s rights.

"It’s time to put an end to laws that let politics trump science and use underhanded means to attack a woman’s constitutionally guaranteed right to safe, legal abortion."

The Center for Reproductive Rights has challenged unconstitutional restrictions on medication abortion in four states in the last few years.  Restrictions challenged by the Center have been in effect in Texas and North Dakota since 2013 and 2014 respectively, while challenges to restrictions on medication abortion in Arizona and Oklahoma are currently enjoined as they move through the courts.

Women in the United States have been safely and legally using medication abortion for over nearly two decades, with approximately one in four women who make the decision to end a pregnancy in the first nine weeks choosing this method.  Major medical groups oppose laws which severely restrict access to medication abortion.  Both the American Medical Association (AMA) and the American College of Obstetricians and Gynecologist (ACOG) have submitted amicus briefs opposing restrictions on medication abortion in Arizona and Texas.  These types of restrictions ignore years of doctor’s practical experience and scientific advancement, forcing providers to prescribe the medications with an inferior, outdated, and less effective procedure.

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The Center for Reproductive Rights uses the law to advance reproductive freedom as a fundamental human right that all governments are legally obligated to protect, respect, and fulfill.

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