many pregnancies remain unintended

many pregnancies remain unintended

Over-the-Counter Oral Contraceptives to Reduce Unintended Pregnancies

Kunal K. Sindhu, MD; Eli Y. Adashi, MD, MS

Author Affiliations Article Information

JAMA. Published online February 28, 2020. doi:10.1001/jama.2019.21862

In 1960, the first combined oral contraceptive (COC), consisting of mestranol and norethynodrel (marketed in the United States as Enovid), became available on a prescription-only basis and was expected to reduce unintended pregnancies. However, more than 50 years later, and despite the availability of numerous other oral contraceptive agents, many pregnancies remain unintended. In 2011, for example, the latest year for which data are available, 45% of pregnancies in the US were classified as unintended. According to the World Health Organization, an unmet need for contraception contributes to unintended pregnancy, and the need to obtain a prescription can act as a barrier to accessing COCs in the US. Without over-the-counter (OTC) contraceptive options, reducing unintended pregnancies will require improved access to prescription-only COCs. In recent years, there has been increased interest in federal-, state-, and market-based efforts to improve accessibility to COCs. This Viewpoint describes this evolving national landscape, including the possibility of attaining OTC status for these medications.

When the first oral contraceptive was approved for use, only a limited body of long-term safety data was available. The US Food and Drug Administration (FDA) thus mandated that “the pill” be made available on a prescription-only basis. This requirement has limited the accessibility of COCs, because obtaining a prescription has historically required an in-person appointment with a physician. These visits can present logistical challenges for patients and, if an appointment is missed, can lead to gaps in adherence. Moreover, contemporary low-dose COCs are considered safe and effective, and many women for whom the use of COCs may be contraindicated (such as those with a history of ischemic heart disease, migraines with aura, and venous thromboembolism) can reliably self-identify without the input of a physician. These developments have called into question the prescription-only status of COCs and support the implementation of a change from prescription to OTC availability. The idea of a prescription-to-OTC switch is not a novel concept, and prior research has found that medication use increases significantly after such transitions.

In recent years, federal efforts to expand access to COCs have focused on eliminating the prescription-only requirement. The notion of a prescription-to-OTC change received significant attention during the midterm congressional elections of 2014. In 2015, Sen Kelly A. Ayotte (R-NH) introduced the Allowing Greater Access to Safe and Effective Contraception Act. Per the Congressional Research Service, the bill would have required the FDA to prioritize the review of supplemental new drug applications (sNDAs) for “contraceptive drugs intended for routine use that would be available to individuals aged 18 years and older without a prescription.” The bill also would have encouraged the submission of such sNDAs by waiving filing fees. In 2015, Sen Patty L. Murray (D-WA) introduced the Affordability Is Access Act, which would have required insurance coverage of OTC oral contraceptives without cost-sharing. While both of these bills have subsequently been reintroduced in the Senate, neither has received a vote. The Over-The-Counter Contraceptives Act of 2016, sponsored by Rep Mia B. Love (R-UT), also did not receive a vote.

An sNDA intent on a prescription-to-OTC switch requires the relevant drug sponsor to conduct postmarketing surveillance reports and consumer behavior studies. Such studies must assess label comprehension (whether consumers can interpret the information afforded by OTC labels), self-selection (whether consumers can apply the information afforded by OTC labels to themselves), actual use (whether consumers can correctly use the medication), and human factors (whether the product interface can be refined and improved so as to enhance actual use). While these requirements have been deemed burdensome by some, final approval or nonapproval decisions issued by the FDA are nevertheless based on the amenability for safe self-use of the drug. To date, no sNDAs have been filed by a COC sponsor intent on effectuating a prescription-to-OTC switch. Steep user fees, legal expenditures, and data acquisition costs figure prominently in such go-forward decisions and may be contributing to an unfavorable cost-benefit ratio. Memories of the troubled prescription-to-OTC switch for emergency contraception also may be serving as a deterrent. Viewed in this light, the prospect of FDA-approved OTC COCs is still likely years away from becoming available.

As federal efforts have stalled, several states have adopted initiatives to improve access to COCs. The Affordable Care Act requires health insurance plans to cover at least 1 form of each of the 18 types of FDA-approved contraceptive methods without cost-sharing. Fourteen states and the District of Columbia have further lowered financial access barriers by prohibiting cost-sharing for all FDA-approved contraceptives, including COCs. Eighteen states and the District of Columbia obligate health insurance plans to cover an extended (eg, year-long) supply of FDA-approved prescription-only contraceptive drugs, a practice supported by the results of a 2011 study that showed that women in California who received a 1-year supply of oral contraceptive pills had significantly lower rates of unintended pregnancy and abortion as compared with women who received a 1- to 3-month supply. An additional 12 states and the District of Columbia now allow pharmacists to prescribe FDA-approved hormonal contraceptives. An analysis of Oregon’s 2016 law that expanded pharmacists’ prescribing authority linked the statute to 51 averted unintended pregnancies and $1.6 million in cost-savings among the state’s Medicaid population at risk for unintended pregnancy over its first 24 months. Additional studies are needed to further clarify the outcomes related to these efforts.

Distinct from these state-based efforts, a number of for-profit and nonprofit organizations have become involved in efforts to expand access to COCs. For example, Nurx and Planned Parenthood Direct, apps separately available in 27 states and the District of Columbia, allow users to obtain a variety of contraceptives via online services subject to review by a licensed medical professional. By dispensing with the need for an in-person appointment with a physician, both programs ease access barriers to COCs. However, the long-term prospects for these efforts are still in question. In recent years, 18 states have banned the use of telemedicine for the provision of drugs used to effectuate medical abortions. While Nurx does not offer abortifacients, it does offer emergency contraception. The viability of these efforts may thus ultimately depend on their ability to avoid the prolife-prochoice schism.

As federal efforts to expand access to prescription-only COCs have stalled, state and online market initiatives have advanced. Collectively, these latter efforts have noticeably improved access to COCs, and thus may hold the key to reducing the unintended pregnancy rate in the US in the near-term. While the American College of Obstetricians and Gynecologists recently called for “over-the-counter access to hormonal contraception without age restrictions,” an FDA-approved OTC COC must be viewed as a long-term proposition.