By Adam Sonfield and Sneha Barot, Guttmacher Institute
In recent weeks, some opponents of the Affordable Care Act’s (ACA) contraceptive coverage guarantee have promoted the idea that oral contraceptive pills should be available to adult women without a prescription. Sens. Kelly Ayotte (R-NH) and Mitch McConnell (R-KY), for example, recently introduced the so-called Preserving Religious Freedom and a Woman’s Access to Contraception Act, a bill that would urge the Food and Drug Administration (FDA) to study whether to make contraceptives over the counter (OTC)—though for adults only.
Making birth control pills available over the counter, if done right, would meaningfully improve access for some groups of women. However, such a change is no substitute for public and private insurance coverage of contraceptives—let alone justification for rolling back coverage of all contraceptive methods and related services for the millions of women who currently have it.
The Policy Behind Over-The Counter Contraception
Making birth control pills available OTC has merit, and the Guttmacher Institute is part of a coalition that has been working toward this goal for years. Leading medical groups have also endorsed such a move, including the American Medical Association and the American Congress of Obstetricians and Gynecologists. By removing the need to obtain a prescription, OTC status would eliminate this potential barrier to contraceptive use and thereby increase access.
This is especially true for uninsured women and those who don’t have time for a doctor’s visit or otherwise can’t readily reach a health care provider. However, if the goal is to truly expand access to contraceptive care—and not just provide cover for undercutting insurance coverage for contraceptives—the case to move birth control pills to OTC status should proceed alongside several other important policies and goals:
Protect contraceptive coverage and full method choice: The ACA requires most private health plans to cover the full range of women’s contraceptive methods and services, without out-of-pocket costs for the patient. This policy eliminates cost as a barrier to women’s ability to choose the method that is best for them at any given point in their lives, an approach that has been proven to make a substantial difference in facilitating access to and use of contraceptive services.
Contrary to what some policymakers and commenters have claimed, giving the pill OTC status would not be an effective substitute for the ACA policy. First, it would do nothing to help women access any contraceptive method other than the pill. This matters, since most women use four or more different contraceptive methods over their lifetime to meet their changing needs. If only the pill were available OTC and contraceptives were no longer covered by insurance, women would face significant new barriers in choosing the method that best suited their needs. Cost is a particularly steep barrier for highly effective methods like the IUD or implant that not only have high upfront expenses, but also require a trained provider for insertion and therefore are not candidates for OTC status.
Even for the pill itself, there is no convincing evidence to suggest that moving it to OTC status would substantially lower out-of-pocket costs to patients, let alone come close to the $0 out-of-pocket cost guaranteed under the ACA policy. Rather, making the pill available OTC, if done at the expense of insurance coverage, would replace one barrier (ease of access) with another (cost). Likewise, greater reliance on Health Savings Accounts or Flexible Spending Accounts, as some opponents of insurance coverage have proposed, would also merely replace full insurance coverage with patient out-of-pocket costs—leaving most privately insured women, particularly low-income women, worse off. Uninsured women on average pay $370 for a full year’s supply of the pill, the equivalent of 51 hours of work at the federal minimum wage of $7.25.
Millions of women already benefit from the ACA’s contraceptive coverage guarantee and these hard-won gains must be protected. Rather than substituting for contraceptive coverage of all methods and related services, OTC status for birth control pills should complement and enhance such coverage.
Strengthen coverage for over-the-counter methods: While the ACA’s preventive care provision specifically requires private health plans to cover certain products with over-the-counter status (including the emergency contraceptive Plan B, folic acid, aspirin to prevent heart disease and tobacco use cessation products), a prescription is needed for these items to be covered—essentially negating the benefits of OTC status. This prescription requirement should be eliminated for any current and future over-the counter contraceptives. Coverage of over-the-counter products without a prescription is already the norm in some state Medicaid programs and in the U.S. military’s Tricare insurance program. Further, ensuring full coverage for over-the-counter contraceptives would prevent "free-riding" by insurance companies that benefit from not having to cover pregnancies that were averted through patient out-of-pocket expenditures.
Ensure equal access for young women: Adolescents and young women, who face greater risk of unintended pregnancy and more barriers to accessing contraception than older women, have among the most to gain from a switch to OTC status. However, recent calls to give birth control pills OTC status as a substitute for contraceptive coverage have specifically excluded minors. That would require women 17 and younger to obtain a prescription, without providing any medical evidence to justify such restrictions. This approach would be harmful to adolescent women and would be counterproductive to helping them avoid unplanned pregnancies and the negative health, social and economic consequences that often follow.
In addition, excluding minors would likely not result in a true over-the-counter status, but instead could put contraceptive pills behind the counter, much as happened when the emergency contraceptive Plan B was first approved for OTC sales. To comply with an age restriction, stores would have to require proof of age via a valid picture ID from any woman who looks young enough to potentially be barred from purchasing birth control pills without a prescription. This would be an added hurdle for millions of women, and it ignores the reality that many young women do not have government-issued forms of photo ID.
Keep politics out of FDA decision making: To switch any drug to OTC status, the typical process involves the drug’s manufacturer submitting an application to the Food and Drug Administration (FDA), which—based on several criteria, including the safety and efficacy profile of the medication—decides whether to grant the request. The evidence is quite strong that providing birth control pills OTC would be safe and effective, including for minors. The FDA process should be driven by the evidence and free from political interference by the administration, Congress and others.
It is troubling but not at all surprising that Senator Ayotte and others who purport to be interested in contraceptive access would preempt the FDA with unfounded calls to bar minors from benefiting from any future OTC status for birth control pills. This echoes the longtime political and legal wrangling over minors’ access to OTC emergency contraceptive pills, despite clear evidence that minors could safely use these products without a prescription.
It is also noteworthy that there are dozens of brands and formulations of birth control pills, most of which would likely have to undergo the lengthy and expensive FDA process to gain OTC status separately. Because formulations of the pill are not medically interchangeable, with some women tolerating specific pills better than others, making one or several versions of the birth control pill available OTC would not benefit all current pill users.
Not A One-Size-Fits-All Policy Solution
Just as birth control methods are not "one size fits all" at any point in a woman’s life, let alone for all of her reproductive years, neither is there a one-size-fits-all policy solution to enhance access to the full range of methods, information and services for women of all ages and income levels, regardless of where they obtain their care. A wide range of approaches is necessary to meaningfully respond to women’s family planning needs in a comprehensive way.
One such approach includes making birth control pills available over-the-counter, if done so without additional costs or barriers to women. Doing so can complement and enhance current efforts to help more women become effective contraceptive users, including the ACA’s significant gains for comprehensive private and public insurance coverage for contraceptive counseling, services and supplies.
If anything, contraceptive coverage should be broadened to cover more women and strengthened to eliminate the prescription requirement for OTC methods that are covered. Other urgent priorities include expanded access to Medicaid, public support for safety-net family planning centers and the Title X national family planning program, comprehensive sex education and the development of new contraceptive technologies.
Truly increasing access to contraceptive care requires a multifaceted approach to meet the needs of all women throughout their reproductive lives. Political talking points will not do it.
This article was originally published on Health Affairs Blog at this link.