Birth control pills have a nearly 60-year history of being easy to use, effective, and reliable as a preventative solution to unintended or accidental pregnancy. However, access to these oral contraceptives is unequally distributed, since a prescription is required to obtain them in the US and other countries. Cadence OTC's mission is to remove this barrier by making “The Pill” available over-the-counter (OTC) without a prescription.

Directed by Candence co-founder Robert (Nap) Hosang, this project now enters Phase 2. In the first phase, the off-the-shelf product and its label were designed to be approved by the United States Food and Drug Administration (FDA). However, changes to the pill’s OTC package labeling were imposed, and the final consumer study was not permitted by the FDA. The FDA will require Cadence to develop a technology solution to aid with reliable self-screening and safe self-selection at the point-of-purchase, to dissuade women with certain health conditions from purchasing the drug without consulting a medical professional.

Despite these setbacks, Cadence’s work with the first grant established important milestones such as learning how to create an easy-to-understand OTC label that tests well with adolescents and women with low literacy; building working relationships with clinical research and package design firms; and a better understanding of key FDA concerns.

Phase 2 aims to repeat studies of human factors, label comprehension, and Toxic Shock Syndrome (TSS) consumer studies from Phase 1. It will also include:

• Further development of the technology solution noted above;
• A new TSS study on women with hypertension;
• A final consumer study (an Actual Use Trial) of 1800+ participants;
• Public awareness building about the OTC Pill; 
• Completion of a submission package to the FDA, as well as preparation for a 2025 Scientific Advisory Committee meeting that may facilitate a decision on OTC approval.