FDA panel supports over-the-counter birth control

Federal health advisers said Wednesday that a decade-old birth control pill should be sold without a prescription, paving the way for possible approval in the U.S. in the first over-the -counter contraceptive medication.

A panel of FDA advisors voted unanimously in favor of Perrigo’s request to sell the once-a-day drug over the counter. The recommendation came at the end of a two-day meeting focused on the company’s research on whether women can safely and effectively take the pill without professional supervision. The FDA’s final decision is expected this summer.

If the FDA follows the non-binding recommendation, Perrigo’s drug, Opill, will become the first contraceptive pill to move from behind the pharmacy counter to store shelves. Currently, a prescription is required in the US

Outside experts said they are confident that women of all ages can use the drug properly without first consulting a health provider.

“I believe this is a viable option to support access and support the prevention of unintended and unwanted pregnancy,” said Jolie Haun, a researcher at the Department of Veterans Affairs, who voted in favor of the pill.

The positive vote came despite several criticisms from FDA scientists about how Perrigo studied the drug, including whether study participants understood and followed labeling instructions.

But the panel largely dismissed those concerns, emphasizing the benefits of providing more effective birth control, especially to young people and low-income groups, than what’s available over the counter today, such as condoms and diaphragms.

Most birth control pills used in the US today contain a combination of progestin and estrogen. Opill is part of an older class of progestin-only contraceptives. They generally have fewer side effects and health risks but may be less effective if they are not taken at the same time each day.

Over-the-counter medications are often cheaper, but are often not covered by insurance. Requiring insurers to cover over-the-counter birth control would require a regulatory change by the federal government.

Birth control pills are available without a prescription in most of South America, Asia and Africa.

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