The U.S.’s first over-the-counter birth control pill may be on its way. A panel of FDA advisors voted unanimously to recommend approval of Opill, a progestin-only birth control pill that would be taken daily to prevent pregnancy. Contraceptive pills are already available over the counter in over 100 countries.
The company that makes Opill has not yet announced how much it will cost, and the New York Times reports that it’s unclear whether the Affordable Care Act’s requirement to cover prescription contraceptives without a copay will apply to over-the-counter pills as well. A final decision from the FDA on whether to approve Opill is expected this August.
What kind of contraceptive is Opill?
Opill is a progestin-only birth control pill, sometimes called a “minipill.” Most people who take prescription birth control pills are on a combination pill that includes both progestin and estrogen. We have more information here on different types of birth control pills.
Combined pills are more popular because they don’t need to be taken at the same time every day and because the added estrogen can help to make periods lighter and to treat certain hormone-related conditions and symptoms, like endometriosis. But combined pills aren’t recommended for people who are breastfeeding or who are at an increased risk of blood clots, including smokers over age 35.
Minipills like Opill have fewer of those contraindications, making them arguably safer for over-the-counter use. But if you’re looking for a pill that can control acne or heavy periods, you may prefer a combination pill rather than a minipill. That said, a minipill will prevent pregnancy just as well as a combined pill if you take it according to directions.
Why did this take so long?
Most countries have some form of contraceptive pill available over the counter, but the U.S. never has. Partly that’s because reproductive health has been unnecessarily politicized here, but another reason is that the U.S. doesn’t have a middle ground between prescription and over-the-counter drugs. In some other countries, people have to undergo a screening at the pharmacy to make sure the pills will be appropriate for them; the U.S. doesn’t have that sort of category. Drugs are either available OTC or they’re not.
The FDA advisory panel meeting involved a lot of discussion that boiled down to whether people can be trusted to read and understand the directions that come with Opill. Progestin-only pills need to be taken consistently at the same time every day, for example. The drug information also includes warnings about who should not take Opill, and the fact that it does not protect against sexually transmitted diseases, among other information.
The things you need to understand to take Opill are pretty standard, but there were concerns from panel members and from people advocating against over-the-counter status that some of the customers may be teens who barely know how sex works, much less how birth control pills work. Still, every over-the-counter drug comes with its own warnings and instructions, and customers are trusted to understand these and to make appropriate decisions.
Another common objection is that making people visit a doctor to get their birth control prescription also brings them into contact with a provider who can recommend cancer screenings and other health care. But we don’t make other medications dependent on showing up for screenings; you can buy allergy medication over the counter without needing a colonoscopy or even, for that matter, an allergy test.
Why OTC birth control is important
The American College of Obstetricians and Gynecologists and the American Association of Family Physicians have long argued that birth control should be available over the counter. One presenter at the FDA meeting pointed out that the contraceptive methods currently available without a prescription are the least effective methods we have.
Being able to afford and attend a doctor’s visit just to get a birth control prescription is unnecessary; according to those medical organizations I mentioned above, contraceptive pills are safe enough to be completely appropriate for over-the-counter access. If the FDA agrees, we’ll finally have the option to buy them that way.
