Mar 29, 2023 - Health

FDA advisers set new date to weigh over-the-counter birth control

Arielle Dreher

Illustration of a magnifying glass with a round pill in place of glass — Illustration: Annelise Capossela/Axios

Food and Drug Administration advisers will meet May 9 and 10 to weigh making a contraceptive pill available without a prescription for the first time.

Why it matters: Health experts say making birth control pills available over-the-counter will reduce the number of unwanted pregnancies and could cut down on the need for abortions. But key questions remain over cost and whether insurers will cover them.

Reproductive rights groups, as well as the nation's largest physician groups, back making birth control available without a prescription.

Flashback: HRA Pharma, a French drug company owned by Perrigo, applied to switch its Opill pill from prescription-only to over-the-counter last July.

The FDA in October postponed the meeting of outside experts to help decide the switch.

The details: Opill could generate $100 million in peak sales, according to analysts.

"Just over 15% of women who walk into a pharmacy with a prescription for an oral contraceptive don't walk out with it filled," Raymond James analyst Elliot Wilbur wrote in a note. "This presents a unique capture opportunity since the potential user is already in [the] store."

Between the lines: If the FDA approves Opill for over-the-counter access, questions remain about access and affordability.

The Affordable Care Act requires insurers to cover contraception without cost sharing, but this has been interpreted to apply to prescriptions.
Reproductive health advocates have asked the federal government to clarify that the coverage should also apply to over-the-counter birth control options.

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FDA advisers set new date to weigh over-the-counter birth control

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