Q&A: UW pharmacy professor Donald Downing on the over-the-counter contraception capsule
Alden Woods UW Information
On July 13, the Meals and Drug Administration accepted for the primary time an over-the-counter contraception capsule, anticipated to hit cabinets in early 2024. The approval of the oral contraceptive Opill might drastically increase entry to contraception, which for many years has been obtainable solely by means of a prescription. It’s a uncommon victory for reproductive rights — and the fruits of a 25-year effort to land contraception on drugstore cabinets.
A central participant in that push was Donald Downing, a medical professor of pharmacy at College of Washington and a longtime advocate of reproductive rights. He has labored to interrupt down boundaries to contraception in dozens of states and Indigenous nations, and helped develop the emergency contraceptive Plan B, generally referred to as the “morning-after capsule.”
He additionally sits on the steering committee of the Free the Capsule Coalition, an advocacy group devoted to creating contraception drugs inexpensive, accessible and obtainable over-the-counter nationwide.
UW Information sat down with Downing to speak about Opill’s lengthy path to approval and the significance of increasing entry to contraception.
Q: You’ve been working to make contraception drugs obtainable over-the-counter because the Nineteen Nineties, most notably together with your involvement in creating Plan B. Inform me extra about that work and the way your crew pushed for this approval.
DD: It’s been a protracted street. About 25 years in the past, I attended a nationwide assembly on emergency contraception in Washington, D.C. This was shortly after the FDA accepted Plan B, which was then solely obtainable with a prescription. My fellow advocates and I knew that Plan B was good, nevertheless it wasn’t adequate. We began to formulate a plan to take away that prescription barrier and make Plan B obtainable over-the-counter (word: the FDA accepted the drug for over-the-counter sale in 2006).
On the identical time, the group talked about how we would make ongoing contraception extra available. Most of the individuals who labored on Plan B’s accessibility went on to affix what’s now the Free the Capsule Coalition, which has labored towards this determination for practically twenty years.
Q: Contraception drugs have been obtainable since 1960, however they’ve beforehand all the time been obtainable solely with a prescription. Why is that?
DD: Traditionally, hormonal contraception has been obtainable within the U.S. solely by prescription resulting from issues about security, particularly in merchandise containing estrogen. Moreover, for a few years it was thought that if contraception required a prescription ladies can be extra prone to make medical appointments that additionally checked for breast, cervical and uterine cancers.
However within the 70-plus years of precise use, it seems that contraception was proven to be safer than pregnancies, and in addition that girls have been being held hostage, compelled to bear most cancers screenings earlier than contraception can be prescribed. And since most cancers screenings aren’t related to stopping pregnancies, many ladies simply wouldn’t get them, which meant they couldn’t get contraception. That led to a number of unintended pregnancies.
This understanding has then led to questioning of why most contraception must be prescribed in any respect. Within the case of Opill, the contraceptive has no estrogen and consequently is taken into account safer than the already secure estrogen-containing contraception. For this reason our crew sought out a producer of non-estrogen-containing contraception for over-the-counter sale.
Q: This new capsule comprises the hormone progestin, which has been utilized in oral contraceptives for many years. Is there any distinction between what’s going to quickly be obtainable over-the-counter and contraception drugs obtainable by prescription?
DD: There may be one other over-the-counter contraception capsule already in the marketplace: Plan B and generic variations of Plan B. This product is an emergency contraceptive not designed for ongoing use, however Opill is. They include totally different progestins and are each secure and efficient.
Ongoing contraception is preferable, nevertheless, particularly for people who find themselves routinely sexually energetic. It supplies simpler contraception and prevents the necessity for emergency contraception. Day by day contraception additionally permits cervical mucous to construct up, which prevents sperm from coming into contact with an egg. It additionally always lowers luteinizing hormone, which in flip tips a girl’s physique into pondering that she’s already pregnant.
Knowledge backs this up. Plan B is much less efficient than ongoing contraception while you take a look at stopping unintended pregnancies over a yr’s time.
Q: It’s one factor to permit medicine to be offered over-the-counter, and one other factor to make it truly obtainable to most of the people — particularly to folks with low incomes or those that communicate different languages. What must be carried out to make contraceptives like this inexpensive and accessible?
DD: This isn’t a easy query.
The product have to be stocked by pharmacies and stores and on-line. It have to be priced affordably. Ideally, it have to be coated by private and non-private well being plans, although there are not any present tips on how this is likely to be achieved. It have to be obtainable to folks of all ages. The packaging have to be made readable in at the least English and Spanish — maybe with a QR code hyperlink for different languages. And we should make shopper training obtainable to all.
Additionally, there are billing and insurance coverage questions that have to be addressed. In Washington State, over-the-counter contraception is required to be coated by each private and non-private well being plans. I’m working in Washington and nationally to make clear the pathway for pharmacists to invoice sufferers’ well being plans for over-the-counter contraception. Ideally, we could have this pathway in place earlier than Opill involves the market subsequent yr.
Q: This seems like a one step ahead, two steps again scenario: it’s been barely a yr since Roe v. Wade was struck down, and there’s an ongoing push to dam entry to abortion medicine like mifepristone. How do you sq. this FDA approval, which ought to increase entry to contraception, with the regular rollback of reproductive rights we’ve seen over the previous few years?
DD: Scientific proof received the day with this FDA determination. With the rollback of abortion entry, it solely is smart that girls should have higher entry to contraception to be able to scale back unintended pregnancies. Nearly 50% of all unintended pregnancies within the U.S. lead to abortions. If you happen to can preserve unintended pregnancies to a minimal with a really secure and efficient contraception product, one would possibly anticipate to see demand for abortions to lower.
Over-the-counter contraception implies that ladies don’t want to search out babysitters, take time without work from work or college, or make medical appointments to be able to entry contraception. It’s prone to be seen as extra accessible by low-income ladies who could battle with the aforementioned boundaries to contraception entry. That’s why this determination is so necessary.
For extra data, contact Downing at [email protected].