“We have to make it affordable and available,” Sen. Patty Murray, a Democrat from Washington State and a co-sponsor of the bill, said in an interview in May. “Let’s give women what they need and make sure it’s affordable so there’s equality, and low-income women, women who are struggling for whatever reason, shouldn’t be forced to not have any birth control simply because they don’t can. pay it today,” she added.
Opill is known as a “mini pill” because it contains only one hormone, progestin, as opposed to “combination” pills, which contain both progestin and estrogen. A company that makes a combination pill, Cadence Health, has also been in discussions with the FDA about applying for over-the-counter status.
The FDA analysts who evaluated the data Perrigo presented in its application for over-the-counter Opill expressed 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 avoid the product The FDA analysts also raised questions about whether younger teenagers and people with limited literacy could follow the directions.
Several advisory committee members said that patients with breast cancer, the main disease that prevents them from taking hormonal birth control, usually have doctors who would advise them to avoid birth control pills. They also said that Opill might actually be safest for teenagers because they are very unlikely to get breast cancer. And because young people often start with birth control that they can buy over the counter, it’s especially important for them to have easy access to a method that’s more effective than condoms and other birth control products available in retail stores, the panelists said.
Perrigo reported that study participants took Opill on 92.5 percent of the days they were supposed to take it. Most participants who missed a pill reported that they followed label instructions to take mitigation steps, such as abstaining from sex or using a condom, said Dr. Stephanie Sober, the company’s U.S. medical liaison, on the advisory board. hearing She said that among 955 participants, only six became pregnant while using Opill.
Most people who said they missed a dose attributed it to running out of pills before they could get to one of the study’s restocking sites, results that, Dr. Sober said, “illustrate precisely the barriers to adherence that could be decreased” making the pill available over the counter.