The 1st One-A-Day, Over-The-Counter Birth Control Pill Approved By FDA

Since 1960, every birth control pill has required a prescription. The drug company, Perrigo, offers a once-a-day, over-the-counter pill birth control option for women and girls to purchase.

Opill was approved in 1973 and has not been marketed since 2005, the company said in a statement.

The change in the availability of contraceptives reflects the efforts of medical societies and women’s health groups. This is significant because out of the estimated six million pregnancies in the U.S., approximately 45% of them are unintentional, according to News Nation.

OPILL 👏 IS 👏 FDA 👏 APPROVED! 👏 pic.twitter.com/aEdYMFFaLq

— Opill® (@opill_otc) July 13, 2023

“This is really a transformation in access to contraceptive care,” Kelly Blanchard said, president of Ibis Reproductive Health. “Hopefully, this will help people overcome those barriers that exist now.” Ibis Reproductive Health is a nonprofit group that supported the drug’s approval.

Opill will not require a prescription or have any age restrictions to make a purchase. This benefits low-income individuals, women, and teens of color who face a disproportionate number of barriers to accessing birth control pills, such as costly doctor visits or finding time away from work to attend a doctor’s appointment.

Opill has received significant support because it is associated with fewer safety concerns than newer birth control pills.

Kelly Blanchard of Ibis Reproductive Health said, “It’s been around a long time, and we have a large amount of data supporting that this pill is safe and effective for over-the-counter use.”

After extensive research by Perrigo, the approval was received, but not without hesitation by the FDA. This is because of concerns that women with particular underlying medical conditions may not be aware that they should not use this medication.

The FDA discovered it was difficult for some women to understand the information presented on the drug labels, such as content about women with a history of breast cancer who should not take the pill because it can induce tumor growth. Women experiencing unusual vaginal bleeding are also urged to speak with a doctor before starting the drug because it may reveal a potential underlying medical concern.

Concerning the ongoing debate surrounding women’s reproductive rights, medical professionals, health advocates, and Democratic politicians have lobbied for increased accessibility to birth control. The push for reform regarding birth control access is seen as a pressing issue for these advocates, as some states have restricted women’s reproductive rights.

The Ireland-based company has not released a price for the over-the-counter drug. However, non-prescription medications are typically less expensive than prescription medications. Insurance does not cover these costs.