Women of all ages in America will soon have access to a birth control pill that does not require a prescription, after the US Food and Drug Administration (FDA) approved Perrigo’s Opill (norgestrel).

The progestin-only pill will be the first contraceptive medication in the US that can be bought from the same aisle as paracetamol or toothpaste. Marketed as Opill, Perrigo gained control of the drug after an acquisition of HRA Pharma in 2022. In a statement, the FDA said that the non-prescription availability of the medicine will help reduce barriers to accessing contraceptives.

The once-a-day pill should be available early next year, but its pricing remains to be announced.

The approval comes amidst a widening cultural divide regarding women’s health rights. Many US states have introduced laws that ban abortion after the US Supreme Court overturned Roe v Wade. Opill’s availability opens accessibility avenues to women’s health that have been in an increasing state of flux in the US.

The efficacy of Opill is well documented since its approval in 1973, but, until now, required a doctor’s signature to access it. After studies indicated that public knowledge of Opill, and an understanding of the drug’s label were good enough, the agency greenlit its over-the-counter use following a unanimous vote in May.

The drug’s label does contain warnings for ectopic pregnancy, delayed follicular atresia, bleeding pattern alterations and liver disease. As per the FDA statement on its approval, Opill is safe and effective when used properly.

With this approval, the US joins other countries, including the UK that already have birth control pills available over the counter. There have been continued calls from charities and organisations in the US, such as the American Academy of Family Physicians and a #FreeThePill campaign from Advocates for Youth, to bring birth control pills out from behind the pharmacy counter.

The pill should not be used by women who have had, or currently have, breast cancer or are using any other form of contraception such as an intra-uterine device, vaginal ring, or implant. The FDA was keen to indicate that Opill does not act as an emergency contraception and that side effects such as irregular bleeding, dizziness, nausea, headaches increased appetite, and abdominal pain have been reported.

“Today marks an important step in the drive toward meaningful access to essential healthcare for Americans. The FDA’s approval of the first daily over-the-counter oral contraceptive will provide millions with access to safe and effective birth control without a prescription,” said U.S. Department of Health and Human Services Secretary Xavier Becerra reacting to the approval.

Source: pharmaceutical-technology.com