Over-the-counter birth control pill approved by FDA

Carolyn Sufrin is a physician and an associate professor of gynecology and obstetrics at the Johns Hopkins University School of Medicine and of health, behavior, and society at the Johns Hopkins Bloomberg School of Public Health. As a board-certified obstetrician and gynecologist, her areas of clinical expertise include family planning, general obstetrics, and gynecologic care.

Image caption: Carolyn Sufrin

Image credit: Johns Hopkins School of Medicine

What do we need to know?

The FDA approved over the counter status for the oral contraceptive pill that contains only the hormone progestin. This is a very safe method of contraception that has been in use for many decades. It has very few contraindications, very few risks, is effective, and is a method that many people like to use.

What does this mean in the U.S. going forward?

This means that for people with the capacity to be pregnant have more control over determining if, when, and how they become pregnant and parent. They have a choice to use a safe, effective method of contraception without barriers of having to go to a clinic and get a prescription, worry about prescription refills. The progestin-only pill is much more effective at preventing pregnancy than condoms, which are also available without a prescription. Easier access to this pill through over-the-counter status means that people can go to the pharmacy themselves and decide to use this method. It has the potential to reduce barriers and increase equity in access to contraception.

What happens next?

This will go into effect January 2024. What happens next is that the manufacturer and pharmacies will need to work together to ensure that Opill will be on shelves wherever over the counter medications are sold.

Q+A

Why the FDA’s approval of Opill matters—and what’s next

Carolyn Sufrin discusses the significance of Opill’s OTC availability, what needs to happen next, and why we should view this decision within a broader context

We also need people to be aware of this change, and to be educated about the safety and how to use effectively these pills.

Importantly, there needs to be a concerted effort to make this pill affordable. Having it over the counter will only do so much to improve access and equity if people can't afford it. Additionally, we need to work on getting insurance companies to cover this medication over the counter. Currently, the Affordable Care Act requires insurers to cover prescribed contraceptives. But ACA does not cover the cost of over-the-counter medications. This is an important gap that needs to be filled to truly make this potential for expanded access to contraception a reality.