Source – FDA
The US has approved the first-ever over-the-counter (OTC) contraceptive pill, providing women with a new option for birth control. The progestin-only Opill (norgestrel) will be manufactured by Perrigo subsidiary HRA Pharma and will be available for purchase online and in retail stores early next year. OTC oral contraceptives are already accessible in over 100 countries worldwide.
The FDA advisory committee supported the approval of the “mini-pill” in May. The committee deliberated on concerns about potential misuse and increased unintended pregnancies associated with OTC availability. However, studies indicated that users had a high understanding of proper usage, such as taking the pill at the same time each day and avoiding certain medications that could interfere with its effectiveness.
“Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States. When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.”
– Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research
Approximately half of the 6.1 million pregnancies in the US each year are unplanned, according to the FDA. The agency believes that providing an OTC option may help reduce this number. Opill has been available for 50 years and has a long history of use. As a progestin-only pill without estrogen, it carries a lower risk of rare blood clot-related side effects compared to combination oral contraceptives.
The approval of Opill comes at a time when birth control is a significant issue in the US. Last year, the Supreme Court’s ruling weakened constitutional protection for abortion rights, leading to ongoing battles over access to abortion pills. Anti-abortion groups have also targeted hormonal birth control. In response, President Joe Biden signed an executive order last month to explore ways to enhance access to affordable contraception, including through OTC options.
While FDA approval is an important step, ensuring access to Opill at an affordable price is crucial. Perrigo aims to make the product accessible and affordable for those in need. The company highlighted data from 2016, which revealed challenges faced by nearly a third of adult US women when attempting to obtain a prescription or refill for contraceptive pills, patches, or rings. Barriers included financial concerns, limited transportation to clinics, living in underserved areas with limited clinic availability, and cultural or linguistic challenges. Studies have also indicated that these issues disproportionately affect black women and women of color.
The approval of Opill has received praise from the American College of Obstetricians and Gynecologists, which considers it a significant advancement in reproductive healthcare accessibility.
