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Study: State Restrictions on Mifepristone Keep it From Reaching 'Full Potential'

Study: State Restrictions on Mifepristone Keep it From Reaching 'Full Potential'

July 29, 2015 —Summary of "Mifepristone Label Laws and Trends in Use: Recent Experiences in Four US States," Wendy Sheldon and Beverly Winikoff, Contraception, June 2015.

The use of mifepristone in the U.S. "has risen fairly steadily over time, from just 6 percent of all eligible abortions in 2001 to 29% in 2011," and research "suggests that use of mifepristone relative to all abortions might be considerably higher than 29% if unconstrained access to medical abortion were the norm, rather than the exception," according to Wendy Sheldon and Beverly Winikoff of Gynuity Health Projects.

However, Sheldon and Winikoff noted, "Perhaps as a result of its rise in use over time, or maybe in recognition of its revolutionary potential, anti-abortion activists have recently turned their attention to promotion of mifepristone-specific legislation."

Common Mifepristone Restrictions

According to the authors, "[t]wo common types of mifepristone restrictions" include "'[p]hysician only' laws, which now exist in 38 states, [that] limit provision of medical abortion to licensed physicians despite broad recognition that mid-level providers can also safely administer this medication" and "'[p]hysician presence' laws, which now exist in 16 states, [that] require that the prescribing physician be in the physical presence of the patient, thus preventing use of telemedicine for medical abortion provision."

Further, they noted a "third type of mifepristone restriction" called "'FDA protocol' laws," which aim "to reduce abortion supply and demand through targeting all affected parties: clinics, providers and women." Specifically, such laws -- enacted in three states -- "require that mifepristone be provided in accordance" with outdated FDA labeling, rather than "the current standard of care worldwide." The outdated labeling involves a regimen "that is more expensive and arguably less effective, with greater side effects," mandates "additional clinic visits, and limits use of the drug to 49 days" after a woman' last menstrual period, rather than the safe and effective 63-day limit.

The authors noted that the use of the third strategy "appears to be working." According to Sheldon and Winikoff, a recent review "of the effect of the omnibus anti-abortion legislation in Texas [HB 2] that was enacted in 2013 and included a mifepristone-label restriction found that within six months of enactment, the share of all eligible abortions statewide that were medical declined by 70% when comparing the six month period directly prior to passage of the bill with the six month period direct after its passage." However, "there was just a 13% decline in overall abortion incidence during this same period." Meanwhile, they wrote that the number of abortion clinics in the state decreased by almost 50%.

Methods

"In order to examine further the possible effect of mifepristone-specific restrictions," Sheldon and Winikoff assessed "trends in mifepristone use over a ten-year period (2004-2014) in four large U.S. states: California, New York, Ohio and Texas." The authors wrote that they chose those states "because they each have large populations of reproductive age women and because they fall on opposite ends of the abortion restriction spectrum," with California and New York having "no mifepristone-specific restrictions," and Ohio and Texas each having "mifepristone protocol laws that went into effect in February 2011 and November 2013, respectively."

Sheldon and Winikoff also "documented trends in mifepristone use relative to the number of all abortions in New York and Ohio from 2004 to 2013." The authors based their analyses on data "from the U.S distributor of mifepristone and from the state health departments of New York and Ohio."

Results

Sheldon and Winikoff found "steady increases" in mifepristone use "for most of the 10 year period" in California and New York. They noted that mifepristone use also "increased substantially" in Texas through 2012, but "then began to decline sharply in 2013, the year the omnibus abortion bill went into effect." Meanwhile, mifepristone use in Ohio remained "relatively stable through 2010, followed by a steep decline in 2011 that coincided with enactment of the FDA protocol law." Overall, the authors found mifepristone use in Ohio "has remained relatively flat since 2011 at a level that is about 75% lower than in 2004."

Sheldon and Winikoff also found that "the proportion of all abortions that are medical has been rising steadily since 2006" in New York. Meanwhile, they found a "similar pattern" in Ohio "until 2011, when mifepristone use declined sharply." The authors wrote, "Since then, medical abortions have comprised less than 2% of all abortions statewide."

Further, they noted that the number of abortions declined in New York and Ohio between 2004 and 2013 in accordance with "the larger national trend, yet the scale of decline of Ohio was double that in New York." In addition, the authors wrote that "there were marked differences in both the direction as well as the magnitude of changes in mifepristone use." Specifically, the decline in mifepristone use in Ohio "was nearly five times greater than for all abortions; whereas in New York, mifepristone use increased despite an overall decline in all abortions during the same period," they wrote.

Discussion

"These findings indicate that mifepristone restrictions are having a rapid and detrimental effect on medical abortion use in Ohio and Texas," Sheldon and Winikoff wrote. They noted that the effect of such laws "can be seen in both the timing and scale of the declines, which in both cases coincided with initial enforcement of the FDA protocol laws; as well as in the stark contrast in mifepristone use over time in these four states on opposite ends of the abortion restriction spectrum."

Because of the increased restrictions, "many women in Ohio and Texas who might have selected medical abortion under less restricted and burdensome circumstances, are increasingly resorting to surgical abortion," according to the authors. Further, women who do choose to use "mifepristone in spite of the onerous restrictions are receiving substandard care with the explicit approval of their state governments." Sheldon and Winikoff wrote that the effects of such laws "are still not well known but are almost certainly not trivial," citing research that found that the use of an outdated mifepristone regimen under Ohio's FDA protocol law "is associated with a 2.5-fold increase in the need for additional interventions such as additional misoprostol, aspiration, blood transfusion and/or hospitalization."

However, Sheldon and Winikoff noted that initiatives "to update the FDA label" are taking place, "which could immediately confound the protocol laws in all states in which they have been enacted." Nonetheless, they noted that the implementation of such restrictions "in the first place raises important questions about the role of state governments in regulating medicine." Specifically, the authors wrote that "prescribing drug regimens that vary from approved labeling is lawful, common and frequently accepted as the standard of care," especially for mifepristone. Meanwhile, "state laws that require adherence to the original FDA-approved protocol are not in the interest of any relevant parties involved in this medical procedure," including patients, clinics and drugmakers, the authors wrote.

"Even after 15 years of availability in the U.S., the promise of mifepristone has yet to reach its full potential," Sheldon and Winikoff wrote, adding, "In order to ensure that all American women who want and need medical abortion are able to receive it, the states must no longer be allowed to mandate inferior medical practice."