The Food and Drug Administration has slated a joint committee meeting to review pharmaceutical company Perrigo’s application to make its birth control pills available over the counter, which would be the first-ever daily birth control medication to be available without a prescription.
The Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee will consider if the company’s nonestrogen oral contraceptive can be made available without a prescription on Nov. 18.
FDA TO CONSIDER FIRST OVER-THE-COUNTER BIRTH CONTROL
HRA Pharma, a subsidiary of Perrigo, submitted its application in July, arguing that removing the prescription requirement for Opill, a progestin-only daily birth control pill, would result in more women having access to the contraceptive. Opill has been on the market since it was first approved by the FDA in 1973.
“More than 60 years ago, prescription birth control pills in the U.S. empowered women to plan if and when they want to get pregnant. Moving a safe and effective prescription birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers,” the company said in a press release in July.
The Consumer Healthcare Products Association, a trade association representing manufacturers and marketers of healthcare products, applauded the FDA for considering Perrigo’s application, saying it would expand consumer’s choice.
Birth control pills have already been made available over the counter in several countries, including Turkey, Mexico, and Portugal.
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It’s unclear yet though, if approved, at what cost the birth control pills will be offered to consumers and whether or not insurers would be required to cover the cost under the Affordable Care Act. The ACA requires health insurers to cover contraception without cost-sharing with the consumer, though no birth control pills have been available previously without a prescription.
Birth control pills without insurance cost around $20-$50 per individual pack, adding up to a yearly sum of anywhere from $240 to $600, according to 2017 data from the National Women’s Health Network.
