FDA Approves First Over-the-Counter Birth Control Pill

Opill, a progestin-only oral medication, will likely be available without a prescription early next year.

FDA Approves First Over-the-Counter Birth Control Pill
Image:Perrigo Company/Opill (Other)

For the first time, oral contraceptive birth control pills will be available for purchase without a prescription in the United States. On Thursday morning, the Food and Drug Administration approved Opill, a progestin-only oral contraceptive, for over-the-counter status.

“Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.”

Opill will be available in stores and online in America by early 2024, manufacturer Perrigo Company said in a statement. In May, the agency’s advisory committee voted unanimously to recommend over-the-counter status without an age restriction.

Advocates for Youth organizer Dyvia Huitron called the approval “monumental.” Huitron testified to the FDA panel in May about the importance of accessing contraception as a young person. “I am so glad to know that I, and many others, can now take charge of our health and pick up birth control on our own terms and in our own time,” Huitron said in a statement to Jezebel on Thursday.

Opill is a progestin-only birth control pill. The pill’s active ingredient, 0.075 mg norgestrel, was approved for prescription use by the FDA in 1973. The agency said the company’s OTC application successfully demonstrated that users can use the medication “safely and effectively” by following the directions on the product’s labels, and would not need the oversight of a doctor or other medical professional. The pill, like all oral contraception, must be taken at the same time each day for maximum efficacy.

There’s no word yet on how much the pills will cost. The Affordable Care Act has rules that require insurance companies covering FDA-approved contraceptions available by prescription, but not over-the-counter medications. Perrigo Global Vice President for Women’s Health Frédérique Welgryn said in a statement to investors that the company will work to make Opill “accessible and affordable to women and people of all ages,” which will include establishing an assistance program for some users.

“I want to thank the FDA and its advisory panels, the Free The Pill coalition, the numerous medical organizations and advocacy groups, and all those who wholeheartedly supported this enormous undertaking that has made today a giant leap for women’s empowerment,” Welgryn added.

Sen. Patty Murray (D-Wash.)—one of the congressional leaders pushing to make birth control more accessible and affordable—said Thursday’s announcement was “finally some good news” in reproductive health care. Birth control is safe, effective, and essential—women across America have known that for decades, and I’m glad the FDA has followed the science to finally put over-the-counter birth control on the shelves,” Murray said in a statement.

Murray has introduced the Affordability is Access Act multiple times that would require insurance companies to cover OTC birth control options. “It’s not enough for an over-the-counter birth control pill to be available to women—it has to be affordable, too,” she said. “That’s why we need to pass my legislation that would make certain insurers fully cover over-the-counter birth control, without any out-of-pocket costs.”

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