Sixty-two years after the United States was the first country to offer women hormonal birth control — commonly known as “the pill” —the 12 million American women taking it may eventually be able to get it without a prescription.
Today, HRA Pharma, a French drug manufacturer owned by the Irish pharmaceutical company Perrigo, filed an application with the US Food and Drug Administration (FDA) to make its contraceptive pill available over the counter. The drug, branded Opill, is a progestin-only birth control pill that should be taken daily. It is also known as “mini-pill” because unlike the more common combination pill, it does not contain estrogen, and also has a lower dose of progestin.
Last year, the same company obtained a license to sell an over-the-counter progestin-only pill in the UK, making it the first Western country to approve such a sale.
The Benefits of Over-the-Counter Pills
Over-the-counter contraceptive pill is informally available in more than 100 countries, especially in low- and middle-income countries. This means that although not all countries officially offer hormonal contraceptive pills without a prescription, it is in any case possible to get them at a pharmacy or through other channels. Studies have shown that over-the-counter availability of birth control is associated with higher continuation rates, leading to lower rates of unintended pregnancies.
In the US, about 3 million pregnancies per year (or almost half of the total number of pregnancies) are unintended — much higher than the average of other high-income countries, which is about 35%. According to the Affordable Care Act, most people should have free access to medical contraception, although the medical appointment and other services provided along with the prescription are not in many cases.
Furthermore, those who do not have insurance coverage still have to pay for both the doctor’s prescription and the birth control. For them, the cost of buying hormonal contraceptive pills without the need for a medical appointment decreases, which increases the likelihood of contraceptive use.
It usually takes between 6 months and a year for an over-the-counter application to be evaluated by the FDA.
The American College of Obstetricians and Gynecologists (ACOG) welcomed the news of HRA Pharma’s application and reiterated its long-standing support for non-prescription hormonal contraceptives.
“Data have shown that people in need of contraception are able to use self-examination tools to determine if hormonal contraception is right for them,” the ACOG wrote in a statement. “Although no medical intervention is without risk, scientific evidence has concluded that over-the-counter access to oral contraceptives can be safely achieved and that the overall benefit of increased access to contraception is significant,” it added.
Unlike combination pills, progestin-only pills do not stop ovulation, but make the uterus inhospitable for pregnancy. Compared to combination pills, they have fewer side effects, and are safe for women older than 35 or for smokers, who are otherwise at greater risk for cardiovascular diseases such as heart conditions and stroke. However, they are not indicated for the treatment of polycystic ovary syndrome or other issues such as acne. Another company, Cadence Health, is working on making over-the-counter combination pills, but has not yet submitted a formal application.
Although contraceptives are not the answer to the reduced abortion rights the US currently faces, the ACOG notes that making contraceptives more readily available can help people provide more agency over their own reproductive lives.