FDA Announces Label Change for Medication Abortion Drug Mifeprex: Milken Institute School of Public Health Expert Available for Comment

For Immediate Release: March 30, 2016

Media Contact: Kathy Fackelmann, kfackelmann@gwu.edu, 202-994-8354

FDA Announces Label Change for Medication Abortion Drug Mifeprex:  Milken Institute School of Public Health Expert Available for Comment

WASHINGTON, DC (March 30, 2016)—The U.S. Food and Drug Administration (FDA) today announced a label change for the abortion pill mifepristone (Mifeprex) which will allow providers to prescribe a lower dose of the drug and make other changes that will improve access to medication abortions. The new label also allows the drug to be taken later in pregnancy and will let women take a follow up pill at home. The changes could make it easier for women living in states that have established restrictions on this form of abortion.

“I applaud the FDA for reviewing and approving an updated Mifepristone label to reflect the most up-to-date scientific evidence for a medication abortion,” said Susan F. Wood, PhD, Associate Professor of Health Policy and Management and Executive Director of the Jacobs Institute of Women’s Health at Milken Institute School of Public Health at the George Washington University. “With this updated label, women in states that have passed laws requiring providers to follow the FDA approved label now face fewer barriers to medication abortion.”

States like North Dakota, Ohio and Texas require health care providers to follow the regimen for a medication abortion on the label that went along with approval of mifepristone 15 years ago, Wood says. Research in the last 15 years has shown that women can take a lower dose of the drug, which reduces the risk of side effects from a higher dose. And studies have also shown that women do not need to visit a clinic or doctor’s office for the follow-up pill, which can be burdensome for women who cannot take time off from work and would prefer to carry out this step at home.

The updated FDA label takes into account the current research and will reduce unnecessary restrictions on women trying to access medication abortions, Wood says.

Resources on the scientific evidence related to medication abortions and U.S. policy changes that could make the process safer and more accessible for patients can be found on the Jacobs Institute of Women’s Health website Bridging the Divide project page. These materials have summarized current evidence and address issues related to the different protocols, doses and timing, clinical follow-up, as well as issues such as “reversibility” and the regulatory history and policies related to medication abortion.  They were developed through a rigorous review of the scientific literature to help provide evidence-based information for policymakers and advocates on the topic of medication abortion.

To interview Dr. Wood, please contact Kathy Fackelmann at kfackelmann@gwu.edu or 202-994-8354.

About Milken Institute School of Public Health at the George Washington University: Established in July 1997 as the School of Public Health and Health Services, Milken Institute School of Public Health is the only school of public health in the nation’s capital. Today, more than 1,900 students from 54 U.S. states and territories and more than 50 countries pursue undergraduate, graduate and doctoral-level degrees in public health. The school also offers an online Master of Public Health, MPH@GW, and an online Executive Master of Health Administration, MHA@GW, which allow students to pursue their degree from anywhere in the world.