“We must prioritize affordability and accessibility,” stated Senator Patty Murray, a Democratic representative from Washington State and co-sponsor of the bill, in a May interview. Murray emphasized the importance of providing women with affordable options for contraception to ensure equity. She expressed concern that low-income women and those who are struggling should not be denied access to birth control simply because of financial constraints.
Opill, commonly referred to as a “mini pill,” contains only one hormone, progestin. This sets it apart from “combination” pills that contain both progestin and estrogen. Cadence Health, a company manufacturing combination pills, has also engaged in talks with the F.D.A. regarding the possibility of acquiring over-the-counter status for their product.
During the evaluation of Perrigo’s data submission for nonprescription Opill, F.D.A. analysts raised reservations about whether women with medical conditions like breast cancer and undiagnosed vaginal bleeding, which should prohibit the use of birth control pills, would adhere to the provided warnings and abstain from using the product. The analysts also expressed doubts about whether younger adolescents and individuals with limited literacy would be able to follow the directions.
Advisory committee members countered these concerns by highlighting that patients with breast cancer are typically under the guidance of doctors who would advise against using hormonal contraception. They also noted that Opill may actually be the safest option for adolescents since they are unlikely to have breast cancer. Considering that young people often initiate their contraceptive journey with over-the-counter options, it is crucial for them to have easy access to a more effective method than condoms and other retail store contraceptives.
Perrigo reported an impressive 92.5% pill adherence rate in a study on Opill participants. Even among those who missed a pill, most reported following label instructions to take mitigating measures such as abstaining from sex or using a condom. Dr. Stephanie Sober, the company’s U.S. medical liaison, highlighted that out of 955 participants, only six became pregnant while using Opill.
The majority of participants who missed doses attributed it to running out of pills before they could access one of the study’s resupply locations. Dr. Sober remarked that this situation illustrates the barriers to adherence that could be alleviated by making the pill available over the counter.
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