OPill and What’s Next in the Over-the-Counter Revolution of Contraception 

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Image Credits: @myriamzilles on Unsplash (Unsplash License)


In July 2023, advocates for sexual health justice rejoiced as the campaign to expand contraceptive access in the United States succeeded in bringing birth control pills over-the-counter (OTC). U.S. Food and Drug Administration recently approved OPill (norgestrel) as the first OTC birth control for nonprescription distribution. This marked the FDA’s first steps toward expanding access to daily oral contraceptive use. Granting this effort eliminated certain barriers that limit buyers’ ability to obtain contraceptive pills by removing the requirement for provider referrals. However, the effectiveness of this action may be limited if current insurance standards for sexual health are not also updated to cover the new OTC product. Without updates to coverage that specifically include daily oral contraceptives, individuals covered under Medicaid may face financial barriers when attempting to access over-the-counter oral contraception

America’s Struggle for Affordable and Accessible Contraception

In the United States, barriers to reproductive health care are deeply rooted in the challenges brought by healthcare disparity and systematic discrimination. According to the Free the Pill movement, which is a youth-led network targeting the expansion of birth control pills, one in three adult women face barriers when attempting to receive prescriptions for daily oral contraceptives. Prior to its approval for over-the-counter (OTC) status, obtaining the birth control pill required a complex process involving healthcare providers and physicians. Through this process, Americans often face barriers, such as obtaining primary healthcare approval, requiring parental consent for users under the age of 18, and difficulties accessing transportation when attempting to acquire oral birth control. These barriers are a direct effect of the prescription requirement for oral birth control in the United States. 

It is also worth mentioning that the challenge of accessing oral contraception is unique to the United States. As of March 2024, the birth control pill is available over the counter (OTC) in over 100 countries, including Mexico, the United Kingdom, and India. In these countries, OTC status increased accessibility to contraception and eliminated the barriers that arise from obtaining a prescription. 

OPill

In July 2023, the US Food and Drug Administration (FDA) approved the first daily oral contraception for OTC distribution. Opill (norgestrel) is a progestin-only contraceptive pill that is used to prevent pregnancy and can now be purchased at drug stores, convenience markets, and online. OPill has been circulating for prescription use since 1973 as a form of oral contraception and its effectiveness rate suggests it prevents 98% of unwanted pregnancies in users. The pill’s high rate of effectiveness and its history on the market made it a prime candidate for OTC distribution. 

Since its FDA approval, studies suggested that OPill will drastically lower the rates of unintended pregnancies in the United States; however, this is only when affordability is reached in ordinance with accessibility. In a study surveying a sample size of 2500 American women, when out-of-pocket costs for contraception are eliminated, over 14 million women would be projected to acquire the OTC birth control pill. While the OTC availability of oral contraceptives is likely to expand access to sexual healthcare, users are more likely to switch to oral contraceptives when insurance coverage guarantees affordability. This highlights a vital relationship when considering healthcare policy, where the cost, quality, and access to healthcare services often become a tradeoff. Eliminating the prescription requirement for daily oral contraception will increase its accessibility to users in the United States; however, it comes at the cost of affordability if current health insurance packages do not adjust to cover it. 

Affordability Slipping through the Cracks of American Health Insurance

Making OPill over-the-counter has altered the dynamics of contraceptive access in the United States, with the goal of reaching those most affected by healthcare disparities, specifically lower-income patients. Medicaid is the primary source of healthcare that lower-income patients employ when seeking assistance to afford reproductive healthcare. Under the current standards, OTC contraceptives are generally not covered under Medicaid programs unless an additional prescription is obtained by a doctor or nurse practitioner. Therefore, Medicaid recipients cannot receive insurance coverage for OPill without receiving an additional prescription beforehand. While making oral contraception OTC aimed to expand its accessibility, current Medicaid policy will undermine this goal by upholding the same barriers users have been facing. Furthermore, Medicaid recipients continue to face limitations from caps on prescription refills, age restrictions, and generic requirements, while still only 18 states cover one year’s worth of daily oral contraceptives.

OPill’s introduction to OTC sale is projected to impact private insurance holders similarly. Following the implementation of the Affordable Care Act (ACA) expansions in 2014, the expectations of private insurances, specifically pertaining to coverage of sexual and reproductive health, have increased. ACA expansions require private health plans (group and individual) to include FDA-approved contraceptive methods in coverage plans. These protections require providers to cover birth control and other family planning services without out-of-pocket costs. Private insurers are required to cover prescribed hormonal contraception, emergency contraception, patient education and counseling services, implanted contraceptive devices (IUDs), and barrier methods. Similar to Medicaid’s standards, however, the ACA does not hold private health insurers accountable to fund the OTC distribution of daily oral contraceptives. 

While the approval of OPill improved accessibility for sexual and reproductive healthcare, much work remains for advocates of over-the-counter contraception. Without coverage adjustments, patients covered under Medicaid and private insurance may still face financial obstacles in accessing oral contraception. Going forward, national level interventions propose an effective avenue to explore addressing the discrepancy in health insurance coverage around reproductive healthcare. For instance, these initiatives could come in the form of federal grants or reimbursement programs, incentivizing states to broaden their Medicaid programs to cover the expenses of over-the-counter daily oral contraceptives by providing financial support to run said programs. Ultimately, without initiatives to address health insurance inequity, American health disparity will continue to limit access to reproductive healthcare from the communities that need it most.