Q&A: UW pharmacy professor Donald Downing on the over-the-counter birth control pill
Alden Woods, UW News
On July 13, the Food and Drug Administration approved for the first time an over-the-counter birth control pill, expected to hit shelves in early 2024. The approval of the oral contraceptive Opill could drastically expand access to birth control, which for decades has been available only through a prescription. It’s a rare victory for reproductive rights — and the culmination of a 25-year effort to land birth control on drugstore shelves.
Donald Downing
A central player in that push was Donald Downing, a clinical professor of pharmacy at University of Washington and a longtime advocate of reproductive rights. He has worked to break down barriers to birth control in dozens of states and Indigenous nations, and helped develop the emergency contraceptive Plan B, commonly known as the “morning-after pill.”
He also sits on the steering committee of the Free the Pill Coalition, an advocacy organization dedicated to making birth control pills affordable, accessible and available over the counter nationwide.
UW News sat down with Downing to talk about Opill’s long path to approval and the importance of expanding access to birth control.
Q: You’ve been working to make birth control pills available over the counter since the 1990s, most notably with your involvement in creating Plan B. Tell me more about that work and how your team pushed for this approval.
DD: It’s been a long road. About 25 years ago, I attended a national meeting on emergency contraception in Washington, D.C. This was shortly after the FDA approved Plan B, which was then only available with a prescription. My fellow advocates and I knew that Plan B was good, but it wasn’t good enough. We started to formulate a plan to remove that prescription barrier and make Plan B available over the counter (note: the FDA approved the drug for over-the-counter sale in 2006).
At the same time, the group talked about how we might make ongoing contraception more readily available. Many of the people who worked on Plan B’s accessibility went on to join what’s now the Free the Pill Coalition, which has worked toward this decision for nearly two decades.
Q: Birth control pills have been available since 1960, but they’ve previously always been available only with a prescription. Why is that?
DD: Historically, hormonal birth control has been available in the U.S. only by prescription due to concerns about safety, especially in products containing estrogen. Additionally, for many years it was thought that if birth control required a prescription women would be more likely to make medical appointments that also checked for breast, cervical and uterine cancers.
But in the 70-plus years of actual use, it turns out that birth control was shown to be safer than pregnancies, and also that women were being held hostage, forced to undergo cancer screenings before birth control would be prescribed. And because cancer screenings aren’t relevant to preventing pregnancies, many women just wouldn’t get them, which meant they couldn’t get birth control. That led to lots of unintended pregnancies.
This understanding has then led to questioning of why most birth control needs to be prescribed at all. In the case of Opill, the contraceptive has no estrogen and consequently is considered safer than the already safe estrogen-containing birth control. This is why our team sought out a manufacturer of non-estrogen-containing birth control for over-the-counter sale.
Q: This new pill contains the hormone progestin, which has been used in oral contraceptives for decades. Is there any difference between what will soon be available over the counter and birth control pills available by prescription?
DD: There is another over-the-counter birth control pill already on the market: Plan B and generic versions of Plan B. This product is an emergency contraceptive not designed for ongoing use, but Opill is. They contain different progestins and are both safe and effective.
Ongoing contraception is preferable, however, especially for people who are routinely sexually active. It provides more effective birth control and prevents the need for emergency contraception. Daily contraception also allows cervical mucous to build up, which prevents sperm from coming into contact with an egg. It also constantly lowers luteinizing hormone, which in turn tricks a woman’s body into thinking that she’s already pregnant.
Data backs this up. Plan B is less effective than ongoing contraception when you look at preventing unintended pregnancies over a year’s time.
Q: It’s one thing to allow medication to be sold over the counter, and another thing to make it actually available to the general public — especially to people with low incomes or those who speak other languages. What needs to be done to make contraceptives like this affordable and accessible?
DD: This is not a simple question.
The product must be stocked by pharmacies and retail outlets and online. It must be priced affordably. Ideally, it must be covered by public and private health plans, though there are no current guidelines on how this might be accomplished. It must be available to people of all ages. The packaging must be made readable in at least English and Spanish — perhaps with a QR code link for other languages. And we must make consumer education available to all.
Also, there are billing and insurance questions that need to be addressed. In Washington State, over-the-counter contraception is required to be covered by both public and private health plans. I’m working in Washington and nationally to clarify the pathway for pharmacists to bill patients’ health plans for over-the-counter contraception. Ideally, we will have this pathway in place before Opill comes to the market next year.
Q: This feels like a one step forward, two steps back situation: it’s been barely a year since Roe v. Wade was struck down, and there’s an ongoing push to block access to abortion medication like mifepristone. How do you square this FDA approval, which should expand access to contraception, with the steady rollback of reproductive rights we’ve seen over the last few years?
DD: Scientific evidence won the day with this FDA decision. With the rollback of abortion access, it only makes sense that women must have better access to contraception in order to reduce unintended pregnancies. Just about 50% of all unintended pregnancies in the U.S. result in abortions. If you can keep unintended pregnancies to a minimum with a very safe and effective birth control product, one might expect to see demand for abortions to decrease.
Over-the-counter birth control means that women don’t need to find babysitters, take time off from work or school, or make medical appointments in order to access contraception. It’s likely to be seen as more accessible by low-income women who may struggle with the aforementioned barriers to birth control access. That’s why this decision is so important.