First over-the-counter birth control pill approved in US

The Food and Drug Administration (FDA) on Thursday approved the first birth control pill to be sold without a prescription in the U.S., a move long sought by reproductive health advocates and physicians to make contraception easier to obtain.

Approving Opill for over-the-counter (OTC) use could significantly expand access to contraception, especially for younger women and those in rural and underserved communities, who currently need to overcome logistical barriers to get birth control. 

“Today marks an important step in the drive toward meaningful access to essential healthcare for Americans. The FDA’s approval of the first daily over-the-counter oral contraceptive will provide millions with access to safe and effective birth control without a prescription,” Health and Human Services Secretary Xavier Becerra said in a statement.

The pill’s manufacturer, the Dublin-based Perrigo, said Opill would most likely be available in stores and online starting in early 2024 for women of all ages.

Its cost was not announced, and a key question is how the company will make the pill affordable — the Affordable Care Act requires insurers to cover preventive services including specific types of birth control, but only if they are prescribed. Insurers usually don’t cover OTC products.

Hormone-based birth control has required a prescription, usually so providers can screen for risk of rare blood clots. But OTC birth control is available in more than 100 countries worldwide. 

The push to make birth control available over-the-counter has been happening for years, but after the Supreme Court overturned Roe v. Wade and ended the constitutional right to an abortion, the movement took on more urgency. 

Health advocates say there have been concerns over access to birth control well before the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization. 

But while the ruling last summer gave a jolt of energy to the reproductive rights movement, it also has made it harder to separate the issue of contraception from the politics of abortion.  

A Texas federal judge in December ruled that federal clinics that confidentially distribute contraception to teens violate Texas state law and U.S. constitutional rights. 

And Justice Clarence Thomas argued that the Supreme Court “should reconsider” its past rulings codifying the right to contraception access.

“At a time when reproductive health and rights are under relentless attack, the FDA’s decision clears the way for access to a birth control pill without having to wait weeks or even months for a medical appointment,” said Raegan McDonald-Mosley, CEO of the reproductive rights advocacy group Power to Decide. 

“This long overdue advancement will help more people have the power to decide if, when and under what circumstances to get pregnant and have a child,” McDonald-Mosley said. 

OTC birth control has support from major medical organizations including the American College of Obstetricians and Gynecologists, the American Medical Association and the American Academy of Family Physicians.

Opill was first approved for use with a prescription 50 years ago. It’s what is known as a “minipill” because it is progestin-only pill, rather than a combination pill of progestin and estrogen, so it has virtually no risk of clotting. But it can be less effective if it’s not taken around the same time every day. 

Still, Opill is effective and could help reduce the number of unintended pregnancies. According to the Centers for Disease Control and Prevention, about 45 percent of all pregnancies are unintended.

Updated at 9:41 a.m. ET.