“We need to make it affordable and available,” Sen. Patty Murray, a Democrat from Washington state and a cosponsor of the bill, said in an interview in May. “Let’s get women what they need and make sure it’s affordable so there’s equity, and low-income women, women who for whatever reason are struggling don’t have to be forced to go without any contraception just because they can’t afford it. today,” he added.
Opill is known as a “mini-pill” because it contains only one hormone, progestin, in contrast to “combination” pills, which contain both progestin and estrogen. A company that makes a combination pill, Cadence Health, has also been in talks with the FDA to apply for over-the-counter status.
FDA analysts who reviewed the data Perrigo submitted in its OTC Opill application raised concerns about whether women with medical conditions that should prevent them from taking birth control pills (mainly breast cancer and undiagnosed vaginal bleeding) would follow the warnings and they would avoid the product. FDA analysts also raised questions about whether younger teens and people with limited literacy could follow the directions.
Several members of the advisory committee said that patients with breast cancer, the leading medical condition that prevents them from taking hormonal birth control, often have doctors who advise them to avoid birth control pills. They also said that Opill might actually be safer for teens because they are very unlikely to get breast cancer. And because young people often start out with contraceptives that they can buy without a prescription, it’s especially important that they have easy access to a more effective method than condoms and other contraceptive products available in retail stores, the panelists said.
Perrigo reported that participants in one study took Opill on 92.5 percent of the days they were supposed to take it. Most of the participants who missed a pill reported that they had followed label instructions to take mitigating measures, such as abstaining from sex or using a condom, said Dr. Stephanie Sober, the company’s US medical liaison. ., at the advisory committee hearing. She said that among 955 participants, only six became pregnant while using Opill.
Most of the people who said they had missed doses attributed it to running out of pills before they could get to one of the study refill sites, results that, Dr. Sober said, “precisely illustrate the barriers to adherence that could be reduced” by making the pill available without a prescription.
