Sixty-two years after the US was the first country to offer women hormonal birth control—commonly known as “the pill”—the 12 million American women who take it might finally be able to get it without prescription.
Today, HRA Pharma, a French drugmaker owned by 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, with the brand name of Opill, is a progestin-only birth control pill to be taken daily. It is also known as “mini-pill” because unlike the more common combination pill, it does not contain estrogen, and has a lower dose of progestin, too.
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 sale.
Over-the-counter contraceptive pill is informally available in more than 100 countries, particularly in low- and middle-income countries. This means that while not all of the countries officially offer hormonal contraception pills without a prescription, it’s possible to get it anyway either from 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 a year (or nearly half 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 be able to access medical contraception for free, though in many cases the medical appointment and other services provided alongside the prescription are not.
Further, those who lack insurance coverage still have to pay both for the doctor’s prescription and the birth control. For them, being able to buy hormonal contraceptive pills without the need of a medical appointment reduces costs, increasing 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) has welcomed the news of HRA Pharma’s application, and has reiterated its long-time support for nonprescription hormonal contraceptive.
“Data have shown that people in need of contraception are capable of using self-screening tools to determine whether 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 contraception can be accomplished safely and that the overall benefit of increased access to contraception is significant,” it added.
Unlike combination pills, progestin-only pills don’t stop ovulation, but make the uterus inhospitable for pregnancy. Compared to combination pills, they have fewer side effects, and are safe for women above 35 or for smokers, who are otherwise at increased risk of cardiovascular disease 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 to make combination pills accessible over the counter, but has yet to present a formal application.
Although contraception isn’t the answer to the reduced abortion rights that the US is currently facing, the ACOG notes, making contraceptive medications more easily available can help provide people with more agency over their own reproductive lives.