What the Changes to Abortion-Pill Labels Really Mean

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The drug Mifeprex.
The drug Mifeprex.Photo: Getty Images

Today, the U.S. Food and Drug Administration said it would update the label for medical-abortion drug Mifeprex (mifepristone) — and these changes could make the pill easier for some women to access, thus pissing off those waging war against reproductive rights.

Mifepristone, formerly known as RU-486, is taken in conjunction with another drug, misoprostol, to induce a miscarriage. Women prescribed the drug would take mifepristone at their health-care provider’s office, followed by misoprostol the next day, then follow up with their doctor two weeks later. (In some places, that means three visits to a doc: one for each step.) Such so-called medical abortions accounted for about a quarter of all terminations in 2011, according to the Guttmacher Institute.

Anti-choice states like Texas, Ohio, and North Dakota have passed laws requiring medical providers to stick to the FDA-approved label dating back to 2000. The original prescribing information for mifepristone states that the drug could only be used up to 49 days after the start of a woman’s last period, had to be prescribed by an MD, and needed to be taken in a 600mg dose.

But in May, the manufacturer sent additional clinical evidence to the FDA showing that the drug is just as effective and safe when taken later and in a smaller dose. The FDA approved a revised label, effective immediately, which says women can take a 200mg dose up to 70 days after their period and states that health-care providers other than doctors can prescribe the drug in states where that’s allowed. Plus, women can now take the misoprostol “at a location appropriate for the patient,” which cuts the number of visits from three to two.

Many doctors have been prescribing the drugs this way for some time (it’s an example of off-label use), but now that it’s all officially sanctioned, Texas, Ohio, and North Dakota can go shove it.