Physicians for Reproductive Health: Updated Mifeprex Label Is A Win For Science

Today, the Food and Drug Administration (FDA) announced that it is revising the label of the drug Mifeprex (mifepristone), a critical step that will ensure that this medication can be provided in accordance with the current standard of care. The announcement means that providers in states that have unnecessarily restricted medication abortion access will once again be able to provide a high standard of evidence-based care to their patients.

Dr. Nancy Stanwood, Board Chair of Physicians for Reproductive Health, issued the following statement in response to the announcement:

“We applaud the FDA for recognizing the safety of medication abortion and the voluminous research that shows evidence-based regimens are beneficial to patients. As physicians, we work every day to provide the highest quality care to our patients. An updated label means that providers in states that require adherence to the FDA-approved Mifeprex label will not have to practice outdated medicine.

 “We at Physicians for Reproductive Health believe strongly that access to abortion is crucial to women’s health. We decry the laws and policies that have targeted abortion for unnecessary restrictions in an effort to discourage providers and block patients. Millions of women in the United States and Europe have used Mifeprex to safely end pregnancies, and it was profoundly disappointing to see it restricted in some states for political reasons. Abortion opponents object to medication abortion because it allows women more options for ending an early pregnancy – and they want to restrict access to this safe method of early abortion.

 “I hope that today marks a new chapter in expanding rather than restricting access to safe abortion, providing women with access to the best modern medical care for their reproductive health needs.”

###

Background on mifepristone

The U.S. Food and Drug Administration (FDA) approved a drug called mifepristone, marketed as Mifeprex, for abortion in 2000 after many years of study. It is used in conjunction with another medication called misoprostol. The steady increase in use of medication abortion – now 23% of U.S. abortions – shows that many women prefer this option.

Today’s announcement makes a number of important revisions to the Mifeprex label, including:

  • Lowering the recommended mifepristone dosage from 600mg to 200mg. Numerous studies confirm that mifepristone is equally effective at lower dosages than the regimen in the 2000 label, meaning that a woman can take less medication – resulting in fewer side effects and lower costs.
  • Altering the dosage and route of administration for the second drug in the medication abortion regimen, misoprostol, to reflect the most effective evidence based regimens.
  • Extending the window of use of mifepristone from 49 days to 70 days based on medical research. The time between 49 and 70 days gestation is critical for patient access, as approximately 30% of women who seek an abortion present for care during this time.
  • Allowing health care providers authorized under state law to provide abortion to prescribe mifepristone. The 2000 label restricted distribution to physicians though several states allow advanced practice clinicians to provide abortion care.
  • Ending the requirement that women to have an in-person clinic visit for their follow-up appointments after being prescribed mifepristone. An in-person appointment is not always medically necessary and, when required, creates significant additional costs and barriers to abortion care.