FDA Ruling Reshapes Abortion Battle

(Photo: AP/Olivier Douliery)

Pro-choice and anti-abortion activists rally outside the Supreme Court on March 2, 2016, as the Court hears oral arguments in Whole Woman's Health v. Hellerstedt.

The emotional battle over abortion has been fought out before the Supreme Court, in state legislatures, and on Capitol Hill, but the Food and Drug Administration has just changed the terms of engagement.

The FDA’s decision this week to approve new labeling guidelines for medical abortion delivers a huge victory to the pro-choice movement, and robs pro-life advocates of a key tool for restricting access to the procedure. The action makes the abortion pill mifepristone more widely accessible and easier to administer to women seeking to terminate their pregnancies.

For more than a decade, public health advocates have urged the FDA to relax its labeling rules for mifepristone to bring them more in line with longstanding European practices and with obstetric recommendations. The new guidelines lengthen the window during which women may induce an abortion medically, from 49 to 70 days, and trim from three or four to two the number of trips women will have to make to a medical professional in most states. The new guidelines also permit a nurse practitioner to administer the drug.

Pro-choice advocates are heralding the new guidelines as a political game-changer. “The FDA’s action will go a long way towards allowing women to make their own decisions about their health care, and their futures,” said Ilyse Hogue, president of NARAL Pro-Choice America, in a statement. “This approved label change is welcome news and deserves to be celebrated, especially in the face of a barrage of extreme laws that make abortion unavailable and undermine a woman’s ability to live the life she chooses.”

But pro-life movement leaders are not happy. Since the FDA approved mifepristone in 2000, pro-life state legislators have effectively pushed to limit access to medication abortion, even as they imposed increasingly costly and restrictive mandates on clinics that perform surgical abortion.

In states around the country, abortion opponents have passed three kinds of restrictions on mifepristone, also known as Mifeprex. The most popular curb has been the “physician only” law, which allows only licensed physicians to administer the medication; 38 states have such laws on the books. Sixteen other states have “physician presence” laws that require the prescribing doctor to be in the patient’s physical presence. Such laws have made it impossible for physicians who serve rural communities to prescribe the abortion pill via telemedicine.

Finally, state legislatures in Ohio, Texas, and North Dakota have also curbed abortion-pill access by requiring physicians to administer mifepristone only according to the FDA’s original protocols. Such laws seek to block abortion providers from prescribing the drug “off label,” a common medical practice for mifepristone and other drugs. It’s those laws that this week’s FDA ruling renders effectively moot, by making the broader and more flexible administration of mifepristone the new federal standard.

Until now, state laws banning “off label” use of mifepristone have been extremely effective at curbing medication abortion. In Texas, a controversial omnibus anti-abortion bill that included curbs on “off label” abortion-pill prescription reduced the number of women eligible for medical abortion by 70 percent within six months, according to an article published in the journal Contraception. The Texas law is now the subject of a challenge before the Supreme Court, in the case known as Whole Woman’s Health v. Hellerstedt, that alleges it places an “undue burden” on women’s access to abortion. 

FDA’s new labeling will make it more difficult for states to pass—and perhaps defend—laws that conflict with scientific expertise on the drug. Pro-life advocates are well aware that the FDA’s decision could begin to stem the tide of abortion restrictions. Laws that conflict with the FDA’s new protocol undoubtedly will face a legal challenge. And the abortion pill will now be more accessible and cheaper, since the FDA’s new labeling rules reduce the acceptable dosage of mifepristone, which is typically used in conjunction with another drug known as misoprostol.

Pro-life advocates responded aggressively to the FDA’s decision, charging that it fuels the alleged “abortion profiteering” of Planned Parenthood. (The abortion provider has rejected those allegations following the release of an undercover video that claimed the organization sold fetal tissue for profit.)

“Relaxing the usage protocols allows abortion businesses to step up their aggressive marketing of the drug to vulnerable pregnant women and plays into Planned Parenthood's goal of selling the abortion drug at every one of their outlets, whether their facilities are equipped to cope with known abortion pill complications or not,” stated a press release put out by Operation Rescue. “This creates additional risks to women for the sake of Planned Parenthood's increased profits.”

Another pro-life group, Created Equal, had already scheduled demonstrations at Planned Parenthood clinics across the country for April 4–7 to protest abortion. Those protests will now likely take up the same refrain.

But the FDA’s decision throws pro-lifers on the defensive. On the surface, abortion opponents appear to be winning the political war. In the past three years, pro-life advocates have passed dozens of abortion restrictions at the state level. In the last week alone, two controversial bills were signed into law: Utah passed a law requiring doctors to provide anesthesia to women having abortions at 20 weeks of pregnancy or later. And Indiana Governor Mike Pence signed into law a bill that bans all abortions for reasons of genetic anomaly, and requires all fetal remains to be cremated or buried—even if they result from a miscarriage.

Such laws may be rendered unconstitutional in any case, depending how the Supreme Court—now divided 4-4 following the death of Justice Antonin Scalia—rules in the Whole Woman’s Health v. Hellerstedt case. But for now, the FDA has ended the political and legal fight over medical abortion. Even in states with the strictest abortion restrictions, women will be free to access medication abortion according to protocols that the American Congress of Obstetricians and Gynecologists has said are more in line with “the current available scientific evidence and best practices."

This article was posted in conjunction with the Scholars Strategy Network.

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