First OTC Birth Control Pill Approved

WASHINGTON — A daily oral contraceptive pill containing norgestrel can be sold without a prescription, the FDA announced early Thursday.

It’s the first over-the-counter (OTC) birth control pill to win the agency’s OK. To be sold as Opill, it’s made by the Perrigo unit Laboratoire HRA Pharma.

“Approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online,” the agency said in announcing the landmark decision.

Norgestrel already has a 50-year history as a contraceptive, having been first approved as a prescription product in 1973. The FDA said Laboratoire HRA Pharma met its requirement to show “that the product can be used by consumers safely and effectively, relying only on the nonprescription drug labeling without any assistance from a health care professional.”

“Studies showed that consumer understanding of information on the Opill Drug Facts label was high overall and that a high proportion of consumers understood the label instructions, supporting their ability to properly use the drug when it is available as an over-the-counter product.”

Women’s groups, state officials, and others had long lobbied the agency to allow OTC contraceptive sales, arguing that the products’ safety and ease of use were well known and that women shouldn’t need a doctor’s approval. An FDA advisory committee voted unanimously in May to recommend approval.

As with prescription norgestrel products, the OTC version comes with a number of contraindications including current or previous breast cancer and simultaneous use with another hormonal contraceptive. Women may experience changes in vaginal bleeding.

Notably, the FDA stressed, Opill “is not for use as emergency contraception and does not prevent pregnancy after unprotected sex.”