The FDA Just Removed An Important Barrier to Abortion Access

By Miriam Zoila Pu00e9rez Mar 30, 2016

From mandatory waiting periods to forced ultrasounds, anti-choice policymakers use many tactics to restrict women’s access to abortions. But the Food and Drug Administration just seriously undermined their efforts.

The agency announced today (March 30) that it has updated the labeling for mifepristone (brand name Mifeprex), the first drug used in the two-drug regimen that induces a medication abortion, commonly collectively referred to as the "abortion pill." It’s used very early in pregnancy (now up to 70 days after the start of a woman’s last menstrual period) and is a popular option because it doesn’t require a more expensive surgical procedure. In fact, the manufacturer says that 2.75 million women have used it since it’s approval in 2000.

But the guidelines for mifepristone haven’t been updated since it was introduced, and in the years since, providers have begun prescribing it "off-label." Off-label uses develop as research and medical practice indicate new and better ways for a drug to be used, and it is a very common practice that is employed for many medications.

Providers across the country have adjusted how they use mifepristone in a few important ways:

  1. It’s been found to be effective up to 70th day of pregnancy, rather than the originally stated 49 days. Those few key weeks widely broaden access.
  2. A much lower dose of mifepristone has been found to be just as effective as the one originally prescribed (200 mg versus 600 mg). A lower dose means lower cost and fewer side effects.
  3. Some states, like California, that allow non-physicians to perform certain abortion procedures also allow those practitioners to prescribe medication abortion. That greatly increases abortion accessibility by increasing the number of providers.
  4. The second pill in the regimen—taken a few days after the first pill is administered—can be ingested at home, and does not require a visit to the provider.


To counter these widespread, medically-sound practices, some states have passed laws that explicitly require medical providers to follow the outdated FDA label guidelines for use of mifepristone. Ohio, Texas and North Dakota all have such laws on the books, and other states have similar legislation that is pending in the courts. Chrisse France, executive director of Preterm, the largest abortion provider in Ohio, says that medication abortion rates decreased dramatically after the legislation was passed, dropping from 13 percent of abortion procedures to just 1.9 percent.

Today’s announcement effectively neuters those laws. The FDA’s new approved regimen now reads as follows:

Mifeprex is approved, in a regimen with misoprostol, to end a pregnancy through 70 days gestation (70 days or less since the first day of a woman’s last menstrual period).  The approved Mifeprex dosing regimen is:

  • On Day One: 200 mg of Mifeprex taken by mouth
  • 24 to 48 hours after taking Mifeprex: 800 mcg of misoprostol taken buccally (in the cheek pouch), at a location appropriate for the patient
  • About seven to fourteen days after taking Mifeprex: follow-up with the healthcare provider

Laws that make abortion more costly and more difficult to access significantly impact women of color, especially those with low incomes who might find it challenging to gather the resources to pay for a more costly surgical abortion. Texas in particular, with it’s large Latina immigrant population, now stands to significantly improve access to early abortion. Providers in Ohio, Texas and North Dakota will likely adopt the new guidelines within a week or two, and it will immediately make it easier to obtain a medication abortion.