“We need to make it affordable and available,” Sen. Patty Murray, a Washington State Democrat and one of the bill’s sponsors, said in an interview in May. “Let’s get women what they need and make sure it’s affordable so that there’s equity, and women on low incomes, women who struggle for whatever reason shouldn’t be forced to go without any contraception just because they can’t afford it today.”
Opill is known as a “mini-pill” because it contains only one hormone, progestin, unlike “combined” pills, which contain both progestin and estrogen. The company that makes the combination birth control pill, Cadence Health, has also entered discussions with the Food and Drug Administration about applying for an over-the-counter status.
FDA analysts evaluating the data Perrigo provided in her application for an over-the-counter Opill have raised concerns about whether women with medical conditions that should keep them from taking birth control pills — particularly breast cancer and undiagnosed vaginal bleeding — would follow the warnings. They avoid a product. FDA analysts have also raised questions about whether younger teens and people with limited literacy could follow the directions.
Several members of the advisory panel said that patients with breast cancer, the main medical condition that precludes taking hormonal contraceptives, usually have doctors advise them to avoid birth control pills. They also said that Opill may actually be safer for teens because they are less likely to develop breast cancer. Committee members said that because young men often start using contraceptives they can buy without a prescription, it is especially important that they have easy access to a method that is more effective than condoms and other contraceptive products available in retail stores.
Perrigo reported that participants in a study took Opill on 92.5 percent of the days they were supposed to take it. Most of the participants who missed the pill reported that they followed label directions to take mitigating steps, such as abstaining from sex or using a condom, Dr. Stephanie Suber, the company’s US medical liaison, said at the advisory panel hearing. Of the 955 female participants, she said, only six became pregnant while using Opill.
Most people who said they missed doses attributed it to running out of pills before they could get to one of the study’s resupply sites, findings that, Dr. Contraception available without a prescription.