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Daniel Grossman: 'The approval of Opill — a hard-fought victory for evidence-based reproductive health policy — could help reverse longstanding inequities in contraceptive access.'
showing that most women didn’t support an age restriction. Based on the experience with Plan B, the F.D.A. set targets for the number of adolescents, including those under 15, to be included in HRA Pharma’s studies of Opill studies.
The results of this research demonstrated that adolescents used the product appropriately. Young people themselves were crucial in this process, including by speaking out at the F.D.A.’s advisory committee public hearing in May. Dyvia Huitron, a 19-year-old university student, spoke about the barriers she faced trying to get birth control in Texas and Alabama, including parental opposition and a lack of confidentiality at her university health center. Young people are “capable of coming to terms with what their needs are,” she said. “We should be given the opportunity to make choices for ourselves.” Many of the speakers at the public hearing also discussed the importance of ensuring that any nonprescription birth control pill that is approved be available at low or no cost for anyone who needs it. They were right to point out this issue. Back in 2013, my colleagues and I were frustrated to learn that the retail price for Plan B would be about $60 — too expensive for many people, including some of the people who might need this medication the most. Only later did generics receive approval, which helped drive down the price. Perrigo, which has acquired HRA Pharma, says it is committed to making the product accessible and affordable. But we don’t yet know how that will play out. Ourfound that among people who were interested in using an over-the-counter birth control pill, the most that adults on average were willing to spend was $15 per month; for teenagers, the maximum was $10. As the price increased much beyond these amounts, interest fell off precipitously. This time, we’re better prepared to tackle the affordability issue, but some things are still unknown, including what the price will be at the pharmacy or grocery store when Opill starts being available there, likely in early 2024.have enacted legislation requiring insurance companies to cover over-the-counter contraceptives, and hopefully more will follow suit. As more states require this coverage, insurance companies operating multistate plans may include the benefit more broadly, and both consumers and employers may push insurers in this direction.has also been introduced in Congress seeking to guarantee insurance coverage of over-the-counter contraception. Not only is Opill the first daily contraceptive approved for nonprescription use, it’s also the first oral medication ever approved for over-the-counter sale for chronic use formedical condition, opening the door to approval for other over-the-counter birth control pills, including those containing estrogen, which Opill does not. Now that the first form of over-the-counter birth control has been approved, it will be easier for contraceptive patches and vaginal rings to seek similar approval. The pathway to over-the-counter cholesterol-lowering pills, another preventive medication taken daily, also got a bit smoother. The prescription requirement for mifepristone and misoprostol, pills used in medication abortions, might even be more feasible after the F.D.A. approval. It would surely be an uphill battle among so many political attacks on abortion access, but at least the conversation can now begin in earnest.
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