F.D.A. Approves America’s First Over-The-Counter Birth Control Pill, Set To Be Released In 2024

On Thursday, the F.D.A. approved an over-the-counter birth control pill, the first of its kind in the United States. The pill’s Dublin-based manufacturer, Perrigo Company, said that the drug will become available in early 2024

Since the Supreme Court overturned Roe v. Wade last year, state lawmakers have been moving to limit contraceptive methods. Anti-abortion and Catholic organizations have condemned the use of birth control for years, making it extremely difficult to obtain contraception in certain parts of the country.

In May, a panel of 17 scientific advisers to the F.D.A. — ranging from obstetrician-gynecologists to experts in consumer health literacy — voted unanimously that the need for an over-the-counter birth control pill was simply too dire to halt the drug any longer.

The new medication, Opill, is predicted to be the country’s most essential and accessible birth control method ever. The F.D.A. has declared the drug to be more effective at preventing pregnancy than condoms, spermicides and other forms of contraception. The pill targets young women who may not have the emotional, legal or financial support to safely obtain birth control.

In contrast to other pills that contain progestin — the synthetic version of progesterone — and estrogen, Opill only contains progestin. F.D.A. analysts have voiced concerns that women with certain medical conditions will not adhere to warnings to avoid the product, but deemed the pill safe for the general population.

Perrigo Company has not announced how much the drug will cost, an amount that will be determined by the number of people willing to use the medication. In a statement, the company’s global vice president for women’s health Frederique Welgryn assured consumers that Perrigo would create an assistance program to provide the pill at little-to-no cost to women in need.

Though some states have passed laws requiring health insurance plans to cover over-the-counter birth control, the Affordable Care Act does not. An executive order by President Joe Biden could soon mandate insurers to cover such drugs.

Sen. Patty Murray (D-Washington) took to Twitter on Thursday to celebrate the news, and to promote Democratic efforts to ensure that the medication is accessible.

“With this decision, birth control will soon finally be on shelves and available over-the-counter,” she wrote. “But we can’t stop there. We’ve got to pass my bill with Rep. Ayanna Pressley (D-Massachusetts) to make sure it’s fully covered by insurance and available with no out-of-pocket costs, too.”

This is HUGE news!

With this decision, birth control will soon finally be on shelves and available over-the-counter.

But we can't stop there. We've got to pass my bill with @RepPressley to make sure it's fully covered by insurance and available with no out-of-pocket costs too. https://t.co/vvBfQ1Ud7k

— Senator Patty Murray (@PattyMurray) July 13, 2023