Amid so much discouraging news about reproductive health access in the wake of Roe v. Wade’s demise, the announcement by the Food and Drug Administration on Thursday that it was approving Opill, a daily oral contraceptive, for over-the-counter sale to people of all ages, felt like a breath of fresh air. The evidence is clear that removing the prescription requirement for birth control pills — Opill was the first such medication to be approved but surely won’t be the last — will improve access to a highly effective form of contraception for millions of Americans.
I’ve been involved in efforts to make oral contraceptives available over the counter for almost two decades, working alongside fellow doctors, nurses, lawyers, public health scientists, pharmacists, reproductive justice advocates and youth activists to make the case for this regulatory change, long before any pharmaceutical company expressed interest in submitting an application to the F.D.A. Like many of my colleagues, I’ve been holding my breath for the last year, since HRA Pharma, which manufactures Opill, submitted its application to the F.D.A.
But to my surprise, the Opill approval process went relatively smoothly. My colleagues and I were heartened to see that the conversation around Opill was generally grounded in evidence, rather than politics. We now have hope that other advances could be coming to help offset restrictions on minors’ access to contraception and state-level abortion bans.
A lot could have gone wrong with the Opill process. Remember the fight over Plan B emergency contraception, sometimes referred to as the “morning-after pill?” In 2006, after a highly politicized battle that ran for more than three years, the F.D.A. under President George W. Bush approved Plan B for over-the-counter sale, but only for people 18 or older. Because of the age restriction, the product was shunted behind the pharmacy counter, where the consumer’s age could be confirmed. The F.D.A. asked Plan B’s sponsor for additional data on people 17 and younger to show the product could be used safely and effectively by adolescents. In response, researchers submitted additional research with several hundred young women, age 17 and under, demonstrating that adolescents understood the key concepts in Plan B’s label and used the product appropriately in an over-the-counter simulation study.
It took a change in presidential administration before the F.D.A. recommended approval of Plan B for people of all ages in 2011, five years after the original over-the-counter approval for adults only.
In a move that tarnished his record on reproductive rights, President Barack Obama endorsed a decision by his secretary of health and human services to override the F.D.A.’s decision and block over-the-counter access for anyone under 17. Ignoring the scientific evidence, Mr. Obama expressed concern about 10- or 11-year-olds who might encounter Plan B in drugstores “alongside bubble gum or batteries” and be harmed. It took a lawsuit and almost two more years before emergency contraception was actually available over the counter for people of all ages in 2013.
With Opill, we were ready for a fight around young people’s access. We conducted studies documenting teenagers’ interest in nonprescription birth control, as well as research 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. Our research found 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. At least eight states 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. Legislation 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 for any medical condition, opening the door to approval for other over-the-counter birth control pills, including those containing estrogen, which Opill does not. (Estrogen-containing pills are more popular in the United States, and people using them are more likely to have regular periods as compared to users of progestin-only pills like Opill.) 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.
Research indicates that people are very interested in over-the-counter abortion pills, and a growing body of evidence demonstrates that people can figure out on their own if they’re medically eligible to use them. The expansion of self-managed abortion, particularly since Roe was overturned, suggests that people can safely use these medications on their own.
The approval of Opill — a hard-fought victory for evidence-based reproductive health policy — could help reverse longstanding inequities in contraceptive access. If cost and insurance coverage are worked out, people will soon have more control over their fertility, even as abortion access has been eroded in many parts of the country.
Daniel Grossman is a professor of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco, and director of Advancing New Standards in Reproductive Health. He is a member of the steering committee of the Free the Pill Coalition.
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