FDA Approves Opill as First Over-the-Counter Hormonal Contraceptive Pill in the U.S

FDA Opill Over the Counter Hormonal Contraceptive Pill

By E.Baloyo , Parent Herald Jul 14, 02:10 am

Photo: (Photo : STEFANI REYNOLDS / Getty Images)

The Food and Drug Administration (FDA) has made a groundbreaking decision by approving Opill as the first hormonal contraceptive pill to be available over the counter (OTC) in the United States.

This move comes as a significant win for various medical groups advocating for increased accessibility to birth control, such as the American Medical Association and the American College of Obstetricians and Gynecologists.

The FDA's approval of Opill for OTC sales marks a significant milestone in women's reproductive rights and aims to address the issue of unintended pregnancies in the country.

FDA Approves Opill, First Over-The-Counter Pill

The agency believes that the availability of OTC oral contraception will provide a safe and more effective alternative to existing non-prescription contraceptive methods, contributing to a decline in unintended pregnancies.

According to NBC News, Dr. Melissa Simon, a professor of clinical gynecology at Northwestern University, expressed her enthusiasm for the FDA's decision, highlighting that over 100 countries already offer OTC birth control options.

She stated, "OTC birth control is available in over 100 countries, so we've been behind in availing safe, effective methods such as this oral contraceptive pill to individuals who are trying to avoid pregnancy."

Opill, commonly referred to as the "mini-pill," contains a single hormone called progestin and requires daily intake.

Originally approved by the FDA in 1973 as a prescription medication, Opill has proven to be effective in preventing pregnancy, with an efficacy rate of 93% under typical use, similar to other prescription oral contraceptives.

However, its availability without a prescription will now remove barriers to access, potentially reducing the number of unintended pregnancies.

Improved Access and Convenience

The FDA's approval means that Opill will soon be accessible in various retail settings, including drug stores, convenience stores, grocery stores, and online platforms.

However, it is important to note that the availability of Opill directly off store shelves is anticipated to occur in early 2024, as the manufacturer, Perrigo's HRA Pharma, needs time to prepare for distribution.

It is worth mentioning that the cost of the over-the-counter pill has not yet been disclosed by HRA Pharma.

However, experts suggest that the price point will likely need to be affordable, as OTC medications are typically not covered by insurance.

This affordability factor will play a crucial role in ensuring broader access to the contraceptive pill for individuals seeking reliable and convenient birth control options.

Addressing Safety Concerns and Empowering Women

According to CNN, during the FDA's evaluation process, some concerns were raised regarding the safe usage of Opill among women with breast cancer or a history of breast cancer.

However, the FDA advisory committee members expressed confidence that most women with breast cancer are already aware of the risks associated with hormonal contraceptives and would refrain from using them.

Additionally, there were concerns about potential side effects of Opill, such as vaginal bleeding, and whether users, especially teenagers, would know when to seek assistance from healthcare providers.

However, the FDA committee ultimately agreed that most women are capable of making informed decisions about the appropriateness of the medication for their individual circumstances.

According to the Associated Press, the FDA's approval of Opill provides women in the United States with an additional birth control alternative, offering them more options amidst the ongoing legal and political disputes surrounding reproductive health.

It's important to note that Opill's approval is separate from the current court battles concerning the abortion pill mifepristone.

Anti-abortion groups generally express support for contraceptives, as they are intended to prevent pregnancies rather than terminate them.