National Partnership for Women & Families

In the News

In op-ed, provider calls for long-overdue 'mifepristone revolution'

Despite hopes that the U.S. Food and Drug Administration's (FDA) approval of mifepristone 16 years ago "would revolutionize abortion access, taking the procedure out of clinics and moving it into the privacy of women's homes ... things did not turn out this way," Daniel Grossman, professor of obstetrics, gynecology and reproductive sciences at the University of California-San Francisco, writes in an opinion-piece for U.S. News & World Report.

According to Grossman, "The reasons why access to medication abortion has been constrained are twofold." He writes that not only have states "imposed restrictions on the method," but there are also "restrictions on how the drug itself can be distributed, thanks to the way it was approved by the FDA."

Grossman explains that states have restricted medication access "in a number of ways," including laws that permit "only a physician [to] provide medication abortion, despite the evidence that this option can be safely provided by nurse practitioners, nurse midwives and physician assistants." In addition, "19 states have also banned the use of telemedicine to provide medication abortion, even though research found this model to be safe, effective and well-liked by patients," Grossman writes.

Moreover, Grossman adds that "some states require physicians to follow the protocol described in the FDA-approved labeling of mifepristone that was, up until recently, out of date and not consistent with published evidence." He explains that providers are permitted to prescribe every other drug based on the latest published evidence, regardless of the original label. According to Grossman, such "off-label use of medications is quite common, especially in obstetrics and pediatrics."

Grossman highlights the ramifications of one such antiabortion-rights law in Texas (HB 2) that, among other restrictions, required providers "to follow the outdated protocol," resulting in "more visits, increased costs and limit[ations on] who was eligible for the method, leading to a 70 percent decline in medication abortion." He also cites research on a similar restriction in Ohio that "found that the outdated protocol led to more women needing additional treatment ... to complete the procedure."

While FDA earlier this year "approved an updated label for mifepristone," allowing "physicians in Ohio and Texas, as well as North Dakota, to once again offer medication abortion according to evidence-based protocols," Grossman writes that there still are "restrictions on how mifepristone can be dispensed." For instance, he explains that because of concerns regarding the drug's profile when it was first approved, "mifepristone can only be dispensed at a clinic, doctor's office or hospital, and it cannot be obtained at a pharmacy with a prescription." Grossman writes, "A doctor who wants to provide mifepristone must enter into a relationship with the drug's distributor and self-certify that she or he is competent to do certain things such as determine how far along the pregnancy is, which most physicians who treat reproductive-aged women do on a weekly basis."

According to Grossman, "There is no doubt that these restrictions on where and how the drug is dispensed restrict access." He explains, "It is a hassle to stock medications in one's clinic, and in this era of violence against abortion providers, it is understandable that few physicians want to take the extra step of registering themselves with the company that distributes mifepristone and risk being identified."

Grossman writes, "It is time for these dispensing restrictions on mifepristone to be removed." He not only cites research showing the safety of medication abortion, but adds that the "FDA has recognized how safe the drug is by limiting the types of complications that need to be reported to them" as of March 2016.

"Sixteen years on, abortion politics and stigma are putting the brakes on access to a safe and effective technology that women want," Grossman writes, calling for FDA to remove dispensing restrictions and for states to strike down laws "unnecessarily limiting who can provide medication abortion or how it can be provided." He writes, "After the recent U.S. Supreme Court ruling in Whole Woman's Health v. Hellerstedt, courts are likely to be receptive to overturning laws that restrict access to abortion when such laws confer no health benefit." Grossman concludes, "After almost two decades of waiting, American women deserve to see the mifepristone revolution they were promised at the turn of the century" (Grossman, U.S. News & World Report, 9/30).