The FDA on Wednesday put themselves in the middle of the politics of abortion by expanding its approval of Mifepristone, a drug used for medication abortions, a decision that could make the procedure more easily available in at least three states where it was tightly controlled.
This could be a game changer in Florida, Ohio and Texas where they are limiting a woman’s right to choose. But in at least one state, Arizona, lawmakers already have sent to the governor a bill that seeks to thwart the FDA’s impact by explicitly requiring the old label. By coincidence, it could become law as early as this week.
As abortion clinics across the country continue to close because of targeted GOP legislation, expanding the circle of who can prescribe this pill could be invaluable for many women. Thirty-seven states currently require that mifepristone be provided by a “licensed physician.” The FDA’s new guidelines are a reminder that, as with so many laws imposed on abortion, there’s no good medical justification for that rule.
The agency updated the label requirements for mifepristone, the pill used in a medication abortion, so that some doses can be taken at home. Fewer doctor visits and a lower dosage will make the procedure cheaper; the new protocol also extends from 49 days to 70 days the period of pregnancy during which a woman can use the drug.
“We are delighted,” said Vicki Saporta of the National Abortion Federation, the major professional association for abortion providers. The new move, she said, “brings the label for mifepristone in-line with scientific research and evidence-based practice.”
Warning -This video explains how mifepristone works and is of a clinical nature.
According to the manufacturer, since its approval, more than 2.75 million women in the United States have taken mifepristone to end a pregnancy early in its gestation, choosing it over “surgical” abortion that involves dilation and curettage. The FDA’s new labeling for mifepristone approves using it for 21 more days into pregnancy —from 49 day’s gestation to 70 — and lowers the overall dosage, making it less expensive and reducing side effects.
Doctors often prescribe off-label protocols for their patients in other arenas of medicine, but lawmakers seized on the discrepancy to pass requirements that doctors only use the older protocol.
Women, given the choice, have increasingly chosen medication abortions, which typically allow them to miscarry at home. According to data from the Guttmacher Institute and the Centers for Disease Control, the share of abortions that are induced by pills has risen in recent years.
One tally has medication abortions accounting for 23 percent of non-hospital abortions in 2011, compared to 17 percent in 2008, and the CDC reported a 10-percent rise in medication abortions between 2011 and 2012. But Texas has seen a dramatic drop in medication abortion, down 22 percent between 2012 and 2013.
Though a Texas abortion case before the Supreme Court focused on restrictions to the clinics and ultimately did not include a challenge to the FDA protocol requirement, the dramatic drop in medication abortions drew the attention of pivotal justice Anthony Kennedy. “My reading indicated that medical abortions are up nationwide but down significantly in Texas,” Kennedy told the solicitor general of Texas at oral argument, asking whether that was “the thrust, the impetus, the effect of this law.”
Indeed, recently published data from the Texas Policy Evaluation Project shows that the effect was particularly acute for women whose nearest clinic had closed, 37 percent of whom did not get the medication abortion that they said they preferred.
Mifepristone (brand name Mifeprex) terminates pregnancy by blocking the necessary hormones; doctors prescribe it with a second pill, misoprostol, which induces contractions to start what resembles a heavy period. When the FDA originally wrote the protocol for the drug, it specified a dose of 600
The new label for mifepristone also says that the drug should be “ordered, prescribed and dispensed by or under the supervision of a healthcare provider who prescribes and who meets certain qualifications.”
Crucially, the guidelines do not contain the word physician. Here, the FDA has given at least subtle backing to the argument that women’s health groups—and the World Health Organization—have been making for years: that midlevel providers, such as midwives and nurse practitioners, should be able to administer medical abortions.