FDA approves first US over-the-counter birth control pill

FDA approves first US over-the-counter birth control pill

“We need to make it affordable and available,” Senator Patty Murray, a Washington state Democrat and co-sponsor of the bill, said in an interview in May. “Let’s provide women with what they need and make sure it’s affordable so that there’s equality, and women who are low-income, women who are struggling for whatever reason don’t have to be forced to have any birth control Because they can’t afford to buy it today,” she added.

The Opill is known as the “mini pill” because it contains only one hormone, progestin, unlike “combination” pills, which contain both progestin and estrogen. One company that makes the combination pill, Cadence Health, is also in discussions with the FDA about applying for over-the-counter status.

FDA analysts evaluating data submitted by Perrigo in its application for nonprescription Opill raised concerns about whether women with medical conditions that prevent them from taking birth control pills — Mainly breast cancer and unexplained vaginal bleeding – will follow warnings and avoid. product. FDA analysts also raised questions about whether young teens and people with limited literacy can follow the instructions.

Several advisory committee members said that patients with breast cancer, the main medical condition that precludes taking hormonal contraceptives, usually have doctors who advise them to avoid birth control pills. He also said that Opill may actually be safest for teenagers because they are much less likely to get breast cancer. And because young people often start with contraception they can buy over-the-counter, it’s especially important for them to have easy access to a more effective method than condoms and other birth control products available in retail stores, the panelists said. vitally important.

Perrigo reports that participants in one study took Opill on 92.5 percent of the days they were supposed to take it. The company’s U.S. medical liaison, Dr. Stephanie Sober, told the advisory committee hearing that most participants who missed a pill reported that they had followed label directions to take mitigation steps, such as abstaining from sex or using condoms. did. They said only six of the 955 participants became pregnant while using Opill.

The majority said they missed their dose because the pills ran out before reaching one of the study’s re-supply sites, a result that Dr. Sober said, “obstacles to adherence were clear.” which can be reduced” The pill is available over the counter.

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