Food and Drug Administration advisers concluded that the benefits outweighed the risks of making a hormonal contraceptive pill — sold under the brand name Opill and produced by the French company HRA Pharma — available without a prescription.
If the F.D.A. follows the nonbinding recommendation of its advisers — and there is a chance the agency might not — Opill would become the first and only birth control pill to be available over the counter since oral contraceptives were introduced in the U.S. in 1960. A final decision is expected by early August.
After a two-day meeting, the 17 members of the F.D.A. committee voted unanimously that it would be safe to make Opill available without a prescription, a move that is also overwhelmingly supported by medical associations, including the American College of Obstetricians and Gynecologists and the American Medical Association. 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 and efficient to get it without a prescription.
Progestin-only pills have been widely used in the United States since the first one was approved in 1973. Like other oral contraceptives, they require a prescription from a health care provider or, in some states, a pharmacist.
The advisers’ vote is timely, experts said at the meeting. Almost a year after the Supreme Court overturned Roe v. Wade, and thus the constitutional right to an abortion, the need to expand contraceptive options has become more urgent, they said. Studies show that roughly half of all pregnancies in the United States each year are unintended.
“In the balance between benefit and risk, we have a hard time justifying not taking this action,” Dr. Maria Coyle, the committee chairwoman and an associate clinical professor at the Ohio State University College of Pharmacy, said in the meeting. “The benefits are large, the drug is incredibly effective.”
She added that “the risk of the medication itself is incredibly low for the vast majority of users, and the risk of unintended pregnancy, while real, is less than that of existing over the counter measures of birth control.”
How does the pill work?
Opill, also known as a “mini pill,” contains only progestin, a synthetic version of progesterone. It 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?
Opill has fewer side effects and a lower risk profile than other birth control options, particularly combination pills, Dr. Carolyn Westhoff, a professor of reproductive health at Columbia University, said at the meeting.
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 the combination oral contraceptive is 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?
HRA Pharma has not yet revealed the sticker price, but affordability is going to be one of the main sticking points 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. But that would require the Department of Health and Human Services to direct insurance companies to include Opill, Ms. Singiser said, and 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 go and get a prescription for a mini pill to avoid any out-of-pocket costs, Ms. Singiser said.
If the F.D.A. decides to move on the recommendation, how soon would Opill be available?
The pill could be available almost overnight, Ms. Singiser said. It would simply depend on how quickly HRA Pharma can get the product “on the shelves with the F.D.A.-approved label,” she said.
In other words, theoretically by the end of the summer, she 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.”