The U.S. Food and Drug Administration (FDA) has approved the sale of Opill, the first over-the-counter birth control pill in the country.
The announcement was made by Dublin-based pharmaceutical company Perrigo, with plans for the pill to hit U.S. store shelves and online marketplaces in early 2024.
Frédérique Welgryn, Perrigo’s global vice president for women’s health, remained tight-lipped about the anticipated cost of Opill, which is a vital determinant for how widely the pill will be adopted.
However, she offered assurance that the company is devoted to ensuring the pill is “accessible and affordable to women and people of all ages,” The New York Times reports.
In addition, she mentioned plans for a consumer assistance program that would make the pill available at no cost for some women.
The approval of an over-the-counter contraceptive pill carries significant implications, especially since the Supreme Court overturned the national right to an abortion in the previous year.
This event has intensified debates around contraceptive accessibility.
In May, a 17-member panel comprised of scientific advisers to the FDA unanimously agreed on the reported benefits of non-prescription birth control pills.
The panel included a variety of experts from fields such as obstetrics and gynecology, adolescent medicine, breast cancer specialization, and health behavior and literacy.
A CDC health scientist, Kathryn Curtis, who is also a member of the advisory committee, affirmed, “The evidence demonstrates that the benefits clearly exceed the risks.”
Risks associated with birth control pills include blood clots, heart attack, stroke, and liver disorders, according to Mayo Clinic.
Cost remains a critical factor for advocates of over-the-counter pills.
A survey by the Kaiser Family Foundation (KFF) revealed that 10% of women could not or would not pay out-of-pocket for contraception, while around 40% would pay $10 or less per month, and roughly a third were willing to pay up to $20.
The current legislation under the Affordable Care Act mandates health insurance to cover prescription contraceptives but excludes over-the-counter methods, The Times notes.
Opill, often referred to as a “mini pill,” contains only progestin, unlike “combination” pills that incorporate both progestin and estrogen.
Progestin-only contraceptives have been associated with a small increase in risk of breast cancer.
Small amounts of progestin pass into the breast milk, according to the prescription version of the drug’s package insert, resulting in steroid levels in infant blood.
