FDA advisors backs first OTC contraceptive

An FDA advisory committee has unanimously voted in favour of approval for what could become the first oral contraceptive to be made available in the US without a doctor’s prescription.

The manufacturer of the Opill contraceptive, Perrigo’s HRA Pharma unit, has said it expects to hear the FDA’s final decision on making the product an over-the-counter (OTC) medicine in the summer.

The outcome of the vote came after two full days of discussion about whether making Opill more available without a doctor consultation could lead to inappropriate use and an increase in unintended pregnancies.

The panel concluded that there was no reason people could not follow the instructions in Opill’s labelling, such as taking it at the same time each day, without consulting a healthcare professional. OTC oral contraceptives are already available in more than 100 other countries worldwide.

The verdict comes as birth control has emerged as an increasingly pivotal issue in the US, in light of the landmark ruling by the Supreme Court last year to strip US women of their constitutional protection for the right to abortion, as well as ongoing battles over access to abortifacient drugs.

Opill is a decades-old daily progestin-based pill that does not contain oestrogen, which means it has a reduced risk of causing blood clot-related side effects that are seen rarely with combination oral contraceptives.

Lobbying group Ibis Reproductive Health, which worked with HRA Pharma on compiling the dossier of information needed to file for the switch top OTC from prescription-only status, said the 17-0 vote was a “landmark step” that “reflects the decades of science showing that birth control pills are safe and effective of over-the-counter use for people of all ages.”

If the FDA does approve Opill for OTC use, additional options may soon be on the way. Cadence Health is working towards making an oral contraceptive available in the US, and has said it is planning to file for approval of its Zena combination product.

Much of the discussion around broadening access to oral contraceptives harks back to a 2016 study, which found that nearly one-third of adult US women who had ever tried to obtain a prescription or refill for a contraceptive pill, patch, or ring reported difficulties doing so.

Barriers included financial concerns, lack of transportation to clinics, living in a rural area or underserved community with limited availability of clinics, and cultural and linguistic challenges. Other studies have suggested the issue is more acute for black women and other women of colour.

An FDA approval would “address a key unmet need for contraceptive access, be a ground-breaking expansion for women’s health nationwide, and a step forward toward ensuring people can have improved access to contraception without unnecessary barriers,” commented Frederique Welgryn, Perrigo’s global vice president for women’s health.

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