In 'Transformative Victory' for Reproductive Justice, FDA Approves Over-the-Counter Birth Control

"Groundbreaking," "monumental," and "transformative" were just a few of the words rights advocates used on Thursday to describe the U.S. Food and Drug Administration's long-awaited approval of over-the-counter use of Opill, a birth control pill that was approved for prescription use five decades ago.

The approval could revolutionize access to contraception for young people, low-income people, and others in a country where nearly half of all pregnancies are unintended, said Free the Pill, a coalition of more than 200 reproductive justice groups and advocates who have been campaigning for over-the-counter (OTC) access to birth control for nearly two decades.

"Over-the-counter birth control pills will help bridge gaps in access and give people greater control over their reproductive health and lives," said Victoria Nichols, project director of Free the Pill. "This is a movement win led by a coalition that recognized the potential of over-the-counter birth control pills and worked for nearly two decades to build the evidence, support, and partnerships necessary to make them a reality."

Perrigo Company, the Ireland-based manufacturer which makes Opill, said the contraceptive could be available at pharmacies and stores in the U.S. in early 2024, and CVS has already said it will carry it in its 10,000 locations across the country.

A joint advisory panel at the FDA unanimously recommended approving the pill in May, saying the benefits of permitting OTC use outweighed the risks of people potentially misusing the drug.

The company submitted the results of a study that showed the vast majority of nearly 900 participants took the progestin-only pill at the same time every day as required for it to be effective—or used an alternative form of birth control if they didn't do so. Opill has a 93% effectiveness rate at preventing pregnancy when taken correctly.

The FDA approval was announced just over a year after the right-wing majority of the U.S. Supreme Court overturned Roe v. Wade, clearing the way for at least 14 states so far to ban abortion care and others to severely restrict access.

"I'm thrilled the FDA followed the science and the unanimous decision of its advisory committee and has authorized Opill for sale over the counter," said Debra Hauser, president of Advocates for Youth and a member of the Free the Pill steering committee. "Having an OTC option for birth control pills is incredibly important and long overdue. We know that the far right will continue to attack and limit access to reproductive health care, and we need to ensure young people have everything they need to lead healthy lives and plan their futures."

Advocates said now that the FDA has approved the pill for OTC use, they will fight to ensure Opill is accessible and affordable for anyone who needs it.

The Affordable Care Act requires health insurance plans to cover prescription contraceptives, but not OTC birth control, and a majority of states do not have laws requiring coverage.

The White House and Senate Democrats have taken steps recently, including an executive order and introducing legislation, to require coverage.

"FDA approval is an important step forward, but we must ensure that OTC birth control pills are equitably accessible to all," said Nichols. "To ensure equitable access we must continue to advocate for OTC birth control pills to be affordably priced and fully covered by insurance."

A survey by Kaiser Family Foundation last year found that 10% of women would not be willing or able to pay out-of-pocket for contraceptive pills, and about 40% would not pay more than $10 per month.

The approval has the potential to be "a game-changer for communities impacted by systemic health inequities" if Opill is "available equitably," said Dr. Daniel Grossman, director of Advancing New Standards in Reproductive Health.

He also urged the FDA to go a step further in ensuring reproductive justice for all in the U.S. by approving OTC use of mifepristone, one of two pills used in medication abortions.

"An over-the-counter birth control pill marks a groundbreaking advancement for contraceptive access nationwide," said Lin-Fan Wang, a family physician at QueerDoc. "Today's decision by the FDA reflects decades of data that show progestin-only birth control pills like Opill are safe and effective for use without a prescription. As a healthcare provider, I want my patients to have access to care that helps them plan their reproductive lives and futures without medically unnecessary barriers."