OTC Birth Control Pill Looking for FDA Approval

birth control pill
Source: Freepik

The Perrigo Company is seeking FDA approval for the country’s first over-the-counter (OTC) birth control pill, also called Opill. 

Over-the-counter (OTC) birth control pills are available across countries in Asia, Africa, and Latin America. However, prescriptions are required in New Zealand, Australia, North America, and most of Europe. But the Perrigo Company is hoping to change all that, at least in the United States. 

More than 60 years ago, prescription birth control pills in the U.S. empowered women to plan if and when they want to get pregnant. Moving a safe and effective prescription birth control pill to OTC [over-the-counter] will help even more women and people access contraception without facing unnecessary barriers.

Frédérique Welgryn, Chief Strategic Operations and Innovation Officer at HRA Pharma

What is Opill?

Opill is a prescription-only birth control pill that has been available since 1973. The mini pill contains 0.075mg of norgestrel and is intended for daily use. Norgestrel is similar to the hormone progesterone. It helps thicken the mucus in the cervix and prevents the sperm from reaching the egg; thus, preventing pregnancy. 

Unlike the mini-pill, combined oral contraceptive pills (COCPs) contain both estrogen and progesterone and are often associated with more side effects. Doctors avoid prescribing them to women with certain medical conditions such as liver diseases, bleeding disorders, or breast cancer. Moreover, they increase the risk of heart attack, blood clots, liver tumours, stroke, and death. Since Opill does not contain estrogen, it carries a lower risk of blood clots. Hence, making it a good candidate for an OTC birth control pill. 

According to a 2016 survey, approximately 30% of women face difficulties with obtaining a prescription and refilling their contraceptive pill. An OTC birth control pill can increase women’s access to this contraceptive option by removing these obstacles. 

FDA’s review is expected to take about 10 months. 


Grindlay, K., & Grossman, D. (2016). Prescription Birth Control Access Among U.S. Women at Risk of Unintended Pregnancy. Journal of women’s health (2002), 25(3), 249–254. https://doi.org/10.1089/jwh.2015.5312


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