The abortion drug Mifepristone is pictured.
Photo by Phil Walter/Getty

FDA move could radically transform abortion access

Updated

Advocates for abortion rights don’t get a lot of good news, but Wednesday brought some. The federal Food and Drug Administration has made a major change in how it labels medication that induces abortion, robbing anti-abortion lawmakers of a key tool they have had to limit access.

“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.” 

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 days gestation to 70 — and lowers the overall dosage, making it less expensive and reducing side effects. 

The impact in states like Ohio and Texas may be sweeping. 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.  

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When the FDA approved mifepristone in 2000 after a long and politicized battle, it relied on a prescription regime that was already more than a decade old. “It has been surpassed by a newer regimen that, based on scientific studies, has been shown to be just as effective while using less medication, resulting in fewer side effects and requiring fewer visits to the provider,” according to the Guttmacher Institute.

The FDA change also conforms with what Planned Parenthood and other abortion providers are already doing, unless blocked by law, said Planned Parenthood Federation of America’s Chief Medical Officer Raegan McDonald-Mosley in a statement. “Updating the label to reflect best medical practice represents a significant step forward for science, for women, and for health care providers who want to give our patients the highest quality care,” she added. 

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. Such restrictions have been permanently blocked by courts in Arizona and temporarily in Oklahoma and Arkansas. But such usage has been allowed in Texas, Ohio, and North Dakota to dramatic effect. 

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.

David Brown, an attorney at the Center for Reproductive Rights involved in the Texas case and separate challenges to medication abortion laws in Oklahoma and Arizona, said the reasons for the drop were due to how the restrictions, passed at the same time as part of an omnibus abortion bill, worked in tandem. 

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When the same 2013 law required that abortion providers have local hospital admitting privileges, about half of Texas’s abortion clinics closed. Now, women had a narrower window by three weeks to get to a dwindling number of clinics. “When you add to that the waiting time caused by the closure of clinics, you have a situation where medication abortion is out of reach for many women,” said Brown. 

The old labeling also required a post-treatment examination to the same clinic, 14 days later. “In Texas, where many women now have to drive hundreds of miles to access a clinic, it’s prohibitive,” said Brown. 

A mandatory ultrasound 24 hours before the abortion that must be provided by the same physician, unless a woman lives more than 100 miles away, meant that some women had to make as many as four visits to an abortion clinics. Brown said with the FDA’s new rule, the number will go down to one or two visits. (If the Supreme Court approves the admitting privileges requirement and a separate provision requiring that abortions only take place in ambulatory surgical centers, no more than 10 clinics will remain in Texas, and women will have to take those pills in massive mini-hospitals, an oddity that was not lost on Justice Sonia Sotomayor at argument.) 

In Arizona, where the medication abortion restriction was previously vanquished in court, the legislature has already sent to the governor a bill that would explicitly undercut the FDA’s move today. That law specifies that doctors must follow the label “in effect as of December 31, 2015.” The Arizona Daily Star reported that Republican Gov. Doug Ducey is expected to sign the bill into law.

Said Brown, “It would be the first law that I’m aware of that would specifically require doctors to practice 20th century medicine in the 21st century.”

Abortion, Arizona, Oklahoma, Reproductive Rights and Texas

FDA move could radically transform abortion access

Updated