Opill: The Over-the-Counter Contraceptive Pill.

Abstract

The U.S. Food and Drug Administration has approved the first oral contraceptive pill (OCP) for over-the-counter status. This progestin-only pill contains norgestrel 0.075 mg taken daily, with a Pearl Index estimated at 4.4 (95% CI, 1.9-8.8). This formulation has an excellent safety profile, with current breast cancer as the only absolute contraindication and few relative contraindications. Ultimately, this approval has great potential to improve the accessibility of effective contraception for many pregnancy-capable Americans, especially those who have poor access to the health care system for prescription-required contraception, most notably people who hold marginalized identities. The pill's overall success in reducing rates of unintended pregnancy will rely on its availability, particularly in rural communities that may rely on one pharmacy, and affordability, especially for uninsured or underinsured individuals. However, given the need for improved contraceptive provision, particularly in abortion-restrictive settings, the over-the-counter approval of this daily OCP is a major advancement in the nation's contraceptive ecosystem.