By Adam Sonfield
Senior Public Policy Associate
Over the past several years, a small cadre of socially conservative policymakers and candidates, often hailing from swing states, have started to promote the idea of moving oral contraceptives over the counter (OTC) as a supposed compromise in the political fight over contraception and, more broadly, reproductive health.
Sen. Cory Gardner (R-CO), for example, used the issue to help win his 2014 race. He relied on it to counter his record of opposing the Affordable Care Act (ACA), its contraceptive coverage guarantee, and other policies supporting contraceptive access. Sen. Gardner and Sen. Kelly Ayotte (R-NH) built on that strategy by introducing legislation in 2015 that would create special incentives for manufacturers of oral contraceptives to file an OTC-switch application with the FDA. The issue can be expected to play a significant role in some 2016 elections as well.
As my Guttmacher Institute colleague Sneha Barot writes, there is, in fact, a strong evidence-based case for moving oral contraceptives OTC.1 Numerous medical groups and other reproductive health proponents, including the Guttmacher Institute, have been studying and working toward that step for many years.2 Lifting the prescription requirement could lower barriers to accessing oral contraceptives, and oral contraceptives meet the FDA’s OTC criteria for consumers’ ability to safely, effectively, and correctly use the medication without professional guidance. Yet, an OTC application is a long and expensive process for manufacturers to undertake, and it must be done separately for each specific drug.
PROPOSAL HAS FLAWS
One serious criticism of the Gardner/Ayotte proposal is that it would politicize and undermine the FDA’s scientific and evidence-based process by substituting the judgment of politicians for scientists.
That attitude leads to a second problem: The proposal would prohibit OTC access for anyone younger than age 18. That requirement not only would interfere with adolescents’ contraceptive access, but it also would effectively require government-issued photo identification, which could limit access for many other women, such as undocumented immigrants.
Moreover, the Gardner/Ayotte bill would do nothing to help low-income women facing potential cost barriers to OTC oral contraceptives. Its sponsors are simultaneously on record wanting to repeal the ACA and its guarantee that all women’s contraceptive options must be covered by most private health plans without any patient out-of-pocket costs. These limitations are particularly salient for the millions of women relying on methods other than oral contraception or on oral contraceptive products other than the specific ones that might be granted OTC status. Notably, many experts believe a progestin-only pill, a type used by only 4% of pill users, might be the first granted OTC status, because it has fewer and rarer contraindications than combined oral contraceptives.3
Reproductive health advocates in Congress, led by Sen. Patty Murray (D-WA) and Rep. Tammy Duckworth (D-IL), have introduced their own proposal on OTC oral contraceptives.
In contrast to the Gardner/Ayotte approach, Murray’s bill focuses on access and affordability, by amending the ACA’s contraceptive coverage guarantee to include coverage of any OTC pill, without out-of-pocket costs and without a prescription. Currently, the ACA policy requires coverage of women’s contraceptive options with OTC status, such as levonorgestrel emergency contraception, but only if the woman obtains a prescription. That requirement essentially negates the benefits of OTC status for women concerned about costs.
Murray’s bill also rejects the idea of an age restriction, is deferential to the FDA’s approval process, and includes protections for consumers against interference by retailers with objections to OTC contraceptives, which is another potential barrier to access. The bill is limited in its scope, however: It is designed to apply to private insurance, but not Medicaid, and it would not remove the prescription requirement for other contraceptives with OTC status.
Meanwhile, state-level policymakers and advocates have been taking intermediate steps to remove barriers to hormonal contraceptives. California and Oregon have passed laws granting pharmacists the authority to prescribe some hormonal contraceptives. Once the states promulgate regulations to implement these laws, this “behind-the-counter” model might improve access by eliminating, for many women, the expense and hassles of a doctor’s visit. In addition, Oregon and the District of Columbia have enacted laws requiring insurance plans to cover a full year’s supply of oral contraceptive pills at one time. That approach might promote more consistent contraceptive use.4,5
These intermediate approaches, as well as an actual OTC switch for oral contraception, would complement the wide range of other policies and programs needed to fully address people’s contraceptive needs. That list includes the ACA’s contraceptive coverage guarantee; the ACA’s broader expansions to Medicaid and private insurance; support for safety-net family planning providers, including through the Title X national family planning program; comprehensive sex education; and research and development of new contraceptive technologies.
- Barot S Moving oral contraceptives to over-the-counter status: Policy versus politics. Guttmacher Policy Review 2015;18(4):85-91.
- OCs OTC Working Group. OCs OTC Working Group. Oakland, CA. Accessed at http://ocsotc.org.
- OCs OTC Working Group. Moving oral contraceptives over-the-counter: Frequently asked questions about what we know and what we still need to know. Oakland, CA; 2013. Accessed at http://bit.ly/1l7uVsJ.
- Steenland MW, Rodriguez MI, Marchbanks PA, et al. How does the number of oral contraceptive pill packs dispensed or prescribed affect continuation and other measures of consistent and correct use? A systematic review. Contraception 2013; 87(5):605-610.
- Foster DG, Hulett D, Bradsberry M, et al. Number of oral contraceptive pill packages dispensed and subsequent unintended pregnancies. Obstet Gynecol 2011; 117(3):566-572.