FDA Abortion Pill Label Change Announcement

Illustrated by Mary Galloway.

The FDA just dealt a serious blow to legislators who seek to undercut women's access to abortion care. Today, the agency announced that it has updated the abortion pill's label to reflect how it is currently being prescribed by providers in most states. Meaning: Anti-choice lawmakers will no longer be able to limit abortion access by requiring that providers adhere to unnecessary abortion-pill prescription requirements. For years, doctors have prescribed the drug mifepristone, together with a medication called misoprostol, to induce miscarriage and end early pregnancy. In 2000, the FDA approved the mifepristone brand Mifeprex. The FDA didn't update the drug's label for a decade and a half, even though by 2001, some 80% of abortion providers weren't following that label's instructions. Mifeprex's old label, which was based on outdated clinical evidence from the 1990s, stipulated that a woman take 600 milligrams of the medication within 49 days of beginning her last period, even though doctors have understood for 15 years that Mifeprex is just as effective and safe when prescribed later in pregnancy and in lower dosages. The FDA's new rules increase the window of time in which a woman can take Mifeprex from 49 to 70 days after the beginning of her last period, and they lower the dosage to 200 milligrams. What's more, the new rules reduce the number of clinic visits required of many women who seek medical abortion. The old rules called for patients to visit a clinic three times — one to take Mifeprex, the next to take misoprostol, and the third for a check-in. Now, the label allows for the misoprostol to be taken "at a location appropriate for the patient." (Women are still advised to return to their provider for a check-in one or two weeks after taking Mifeprex; the old recommendation was two weeks.) The new labelling is especially good news for women in North Dakota, Texas, and Ohio, where state laws mandate that abortion providers stick to on-label prescriptions of abortion medication, limiting the number of women who are eligible for or can access it. (This mandate is rolled up in HB2, the insidious anti-choice legislation that closed dozens of abortion clinics in Texas.) President of research organization Gynuity Health Projects Beverly Winikoff, MD, MPH, is encouraged by the FDA's announcement, but recognizes that access to medical abortion remains far too limited. "The good news is that the approved regimen has finally caught up with medical practice and evidence. The bad news is mifepristone remains overly regulated and is still not available in pharmacies," she said in a statement. "While these changes will help many women, additional regulatory changes are essential to maximize access to this important medication. Mifepristone holds untapped potential for improving the availability and affordability of abortion in the U.S."