New FDA label for medical abortion pill, Mifeprex

Statement by Vicki Saporta, President and CEO of the National Abortion Federation (NAF), on the New FDA Label for Medical Abortion Pill, Mifeprex:

We are delighted that the FDA has approved a label change, which brings the label for mifepristone in-line with scientific research and evidence-based practice. Since mifepristone was initially approved by the FDA in 2000, National Abortion Federation members have used an evidence-based regimen, differing from the former label, allowing for a lower 200mg dose of mifepristone; and an alternate dose, route of administration, and place of administration for misoprostol. In 2013, our evidence-based Clinical Policy Guidelines, which set the standards for quality abortion care, also increased the gestational age this care could be provided from 63 days to 70 days.

Because providers in the United States have already been providing evidence-based care, which the new label now recognizes, actual practice will not change. What will change is that politicians can no longer deny women access to this safe and effective method of early abortion care by insisting on an out-dated regimen. We hope the new label changes will soon allow women to access medical abortion care in states where anti-choice restrictions have made this evidence-based care unavailable.

The label change broadening the definition of a prescriber will now also allow advance practice clinicians in some states to provide medical abortion care. This holds the promise of increasing women’s access to this safe and effective method of early abortion, especially in more rural areas where there is not a current abortion provider.

NAF was instrumental in the initial training and education of abortion providers and other health care professionals when mifepristone was first approved by the FDA in 2000. We were also instrumental in informing women that this safe and effective method of early abortion care was available—through a public awareness campaign— and referred women through our toll-free hotline to quality abortion providers who offered this option.

Our members look forward to continuing to provide evidence-based, quality medical abortion care.

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The National Abortion Federation (NAF) is the professional association of abortion providers. Our members include individuals, private and non-profit clinics, Planned Parenthood affiliates, women’s health centers, physicians’ offices, and hospitals who together care for approximately half the women who choose abortion in the U.S. and Canada each year. Our members also include public hospitals and both public and private clinics in Mexico City and private clinics in Colombia.