Perrigo’s Opill Gets FDA Approval as First OTC Oral Contraceptive in US

Pictured: Birth control pills/Shutterstock

Pictured: Birth control pills/Shutterstock

Thursday, the FDA approved Perrigo Company’s Opill (norgestrel), the first over-the-counter oral contraceptive pill to be available in the U.S. without a prescription.

In a press release, Perrigo said the pill will be available online and in-person at drug stores, convenience stores and grocery stores in the first quarter of 2024.

The drug is a once-daily oral contraceptive that contains 0.075 mg norgestrel and one hormone, progestin. Also known as the “mini-pill,”  the progestin-only pill differs from many other oral contraceptives in that it does not contain estrogen. The contraceptive efficacy of norgestrel was first established with the FDA’s approval in 1973.

Perrigo stock was up 6% in premarket trading Thursday in response to the news. The drug was originally owned by HRA Pharma, which was acquired by Perrigo in April 2022.

The approval comes as no surprise to many as the FDA’s Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee (ORUDAC) voted in favor of Opill’s approval in May. The unanimous vote was 17–0 and without abstentions.

Perrigo CEO Patrick Lockwood-Taylor said in the press release that Opill has the potential to “radically transform women’s access to contraception,” and said Thursday’s approval “marks a truly momentous day for women’s health nationwide.”

Perrigo has not announced the price point of Opill. The Affordable Care Act requires most insurance companies to fully cover the cost of Opill and all other contraceptives, so it will still be available at no cost to those who have insurance.

On June 23, President Joe Biden signed an executive order requiring the Secretaries of the Treasury, Labor and Health and Human Services to ensure that private health insurance covers all FDA-approved contraceptives without cost-sharing and “to streamline the process for obtaining care women need and want.”

According to the advocacy group Free the Pill, over-the-counter birth control pills are already in more than 100 other countries.

Nearly half of the 6.1 million pregnancies in the U.S. annually are unintended, the FDA noted in its Thursday announcement. “Availability of nonprescription Opill may help reduce the number of unintended pregnancies and their potential negative impacts,” the regulator said.

Opill is not for use as emergency contraception and does not prevent pregnancy after unprotected sex, according to the FDA.

Rosemary Scott is an editor at BioSpace, focusing on the job market and career development for professionals in the life sciences. You can reach her at rosemary.scott@biospace.com and on LinkedIn.

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