Opill, also known as a “mini pill,” contains only progestin, a synthetic version of progesterone.
The Food and Drug Administration approved a hormonal contraceptive pill to be sold without a prescription, making it the first and only birth control pill to be available over the counter since oral contraceptives were introduced in the U.S. in 1960.
The contraceptive is sold under the brand name Opill and produced by Perrigo Company. The decision, which was overwhelmingly supported by an array of medical associations, including the American College of Obstetricians and Gynecologists and the American Medical Association, comes at a time when experts said expanding contraceptive options to avoid unintended pregnancies has become more urgent in a country where access to abortion has become harder.
A 2022 survey found that 77 percent of more than 5,000 female participants favored the idea of getting the birth control pill over the counter, with many saying it would be more convenient to get it without a prescription.
How does the pill work?
Opill, also known as a “mini pill,” contains only progestin, a synthetic version of progesterone. Progestin-only pills have been widely used in the United States since the first one was approved in 1973. The Opill works primarily by thickening mucus in the cervix to make it harder for sperm to enter the uterus, said Dr. Katrina Heyrana, an OB-GYN at the family planning program at Cedars-Sinai in Los Angeles.
It is also designed to prevent ovulation, but the low dose of progestin means that the pill doesn’t consistently do that, Dr. Heyrana said. Roughly four in 10 women on the mini pill continue to ovulate, according to the American College of Obstetricians and Gynecologists.
Each Opill box includes 28 pills and, if taken at roughly the same time every day with no breaks between packs, it is considered highly effective at preventing pregnancy, with a failure rate of around 7 percent. (This is comparable to combination contraceptive pills that contain both estrogen and progestin.) Research shows progestin-only pills are more effective than the birth control options that are currently available over the counter, such as condoms and spermicides, which have higher failure rates. Birth control pills are less effective than intrauterine devices or sterilizations.
If you are certain you are not pregnant, you can start taking the pill at any point during your menstrual cycle, Dr. Heyrana said. It should start to prevent pregnancies within 48 hours of taking the first pill, so you might need a backup contraception method within that window, she said.
What are the side effects and risks associated with Opill?
Earlier this year, members of an independent scientific advisory group to the F.D.A. noted that the Opill had fewer side effects and a lower risk profile than other birth control options, particularly combination pills.
The most common side effect is unscheduled bleeding throughout the cycle that is heavier than spotting and rarely follows any patterns, said Dr. Heyrana, “which can be quite bothersome for people.”
The Centers for Disease Control and Prevention notes that combination oral contraceptives are associated with an increased risk for cardiovascular disease, hypertension and blood clots. In contrast, according to the C.D.C., the mini pill is not associated with many serious long-term risks.
Research has suggested that taking a progestin pill, like Opill, might exacerbate severe liver disease or breast cancer, so people who have had those conditions should avoid it.
How much will it cost?
Perrigo has not yet revealed the sticker price, but affordability is going to be one of the main concerns for consumers going forward, said Dana Singiser, co-founder of the Contraceptive Access Initiative, a nonprofit organization that advocates for expanded access to contraceptives.
“It is clearly a huge priority for the reproductive health community to make sure that the on-the-shelf price truly is affordable for the consumers who tend to have less access to health care,” Ms. Singiser said.
The Affordable Care Act currently mandates that insurance companies fully cover prescribed contraceptives, and, Ms. Singiser said, reproductive rights activists are hoping that would extend to Opill as well, even if it’s purchased over the counter. In June, President Biden signed an executive order directing the Secretaries of Treasury, Labor and Health and Human Services to take steps to ensure that private health insurance “covers all Food and Drug Administration-approved, -granted, or -cleared contraceptives without cost sharing.” Now, it is up to those agencies to include Opill, Ms. Singiser said, but it’s difficult to determine how long that will take.
Those who do have insurance and access to a pharmacy or a physician can still get a prescription for a mini pill to avoid any out-of-pocket costs, Ms. Singiser said.
How soon will Opill be available?
The pill will be on store shelves and available online in early 2024, the company said.
At that point, Ms. Singiser said, you could “go to the family planning aisle at a CVS or Walgreens or Rite Aid and — right next to the condoms and the emergency contraception — there should be a pack of Opill.”