In the midst of so much discouraging news about reproductive health access after the passing of Roe v. Wade, the Food and Drug Administration’s announcement Thursday that it has approved 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 eliminating prescription birth control pills — Opill was the first such drug to be approved but certainly won’t be the last — will improve access to a highly effective form of birth control for millions of Americans.

I have been involved in efforts to make oral contraceptives available over the counter for nearly 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 FDA Like many of my colleagues, I have been holding my breath for the past year as HRA Pharma, which manufactures Opill, submitted its application to the FDA.

But to my surprise, the Opill approval process went relatively smoothly. My colleagues and I were encouraged to see that the conversation around Opill was generally based in evidence, rather than policy. We now have hope that other advances might come along to help compensate restrictions on minors’ access to contraception and state-level abortion bans.

A lot could have gone wrong with the Opill process. Remember the battle over Plan B emergency contraception, sometimes referred to as “the morning pill?” In 2006, after a highly politicized battle that lasted for more than three years, the FDA under President George W. Bush approved Plan B for counter sale, but only for people 18 or older. Due to the age restriction, the product was moved behind the pharmacy counter, where the age of the consumer could be confirmed. The FDA asked the sponsor of Plan B for additional data on people 17 and younger to show that the product could be used safely and effectively by teenagers. In response, researchers conducted additional research with several hundred young women, ages 17 and under, demonstrating that adolescents understood the key concepts in the Plan B label and used the product appropriately in an an over-the-counter simulation study.

It took a change in presidential administration before the FDA 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 approved a decision by his health and human services secretary to override the FDA’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 come across Plan B in pharmacies “along with chewing gum or batteries” and be harmed. It took a lawsuit and almost two more years before that emergency contraception was actually available over the counter for people of all ages in 2013.

With Opill, we were ready for a battle around the access of young people. We led studies documenting teenagers’ interest in over-the-counter birth control, as well as research showing that most women did not support an age restriction. Based on the experience with Plan B, the FDA has set targets for the number of adolescents, including those under 15, to be included in HRA Pharma’s Opill studies. The results of this research proved that teenagers used the product appropriately.

Young people themselves have been instrumental in this process, including by speaking out at the FDA’s advisory committee public hearing in May. Dyvia Huitron, a 19-year-old college 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 “able to come to terms with their needs,” 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 over-the-counter birth control pill that is approved is available at low or no cost to anyone who needs it.

They have rightly pointed this issue out. Back in 2013, my colleagues and I were upset to learn that the retail price for Plan B would be around $60 – too expensive for many people, including some people who might need this medication the most. Only later did generics get approval, which helped lower the price.

Perrigo, which acquired HRA Pharma, says it is committed to making the product accessible and affordable. But we still don’t know how that will happen. Ours research found that among people who were interested in using an over-the-counter birth control pill, the most adults were willing to spend on average was $15 a month; for teenagers, the maximum was $10. As the price increased much more than these amounts, the interest fell rapidly.

This time, we are better prepared to deal with the affordability problem, but some things are still unknown, including what the price will be in the pharmacy or grocery store when Opill starts to be available there, probably in early 2024. At least eight states passed 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 can include the benefit more broadly, and both consumers and employers can push insurers in this direction. Legislation was also introduced in Congress seeking to guarantee insurance coverage of over-the-counter contraception.

Opill is not only the first daily contraceptive approved for over-the-counter use, it is also the first oral medication ever approved for over-the-counter sale for chronic use. any disease, opening the door to approval for other over-the-counter birth control pills, including those containing estrogen, which Opill does not. (Estrogen pills are more popular in the U.S., and people using them are more likely to have regular periods 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 birth control patches and vaginal rings to find similar approval. The road to over-the-counter cholesterol-lowering pills, another preventative medicine taken daily, also got a little smoother.

The prescription requirement for mifepristone and misoprostol, pills used in medical abortions, could be even more feasible after the FDA approval. It would certainly be an uphill battle amid 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 proves that people can figure out for themselves if they are medically eligible to use them. The expansion of self-administered abortionespecially 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 disparities 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 Promoting New Standards in Reproductive Health. He is a member of the steering committee of the Unleash the Pill Coalition.

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