WASHINGTON (AP) — U.S. officials have granted approval for the first over-the-counter birth control pill. This means that American women and girls will be able to purchase contraceptive medication without a prescription, alongside products like aspirin and eyedrops. The Food and Drug Administration (FDA) announced on Thursday that they have cleared Perrigo’s once-a-day Opill for non-prescription sales, making it the first medication of its kind to be available without a trip to the pharmacy counter. Perrigo is expected to start shipping the pill in early 2023, and there will be no age restrictions for its purchase.
Hormone-based pills have been the most common form of birth control in the U.S. since the 1960s, used by millions of women. However, until now, they all required a prescription. Medical societies and women’s health groups have pushed for wider access to birth control, highlighting that approximately 45% of the 6 million pregnancies in the U.S. each year are unintended. Certain groups, such as teens and girls, women of color, and those with low incomes, often face greater obstacles in obtaining prescriptions and picking them up, which can include financial challenges, difficulty taking time off work, and finding child care.
Kelly Blanchard, president of Ibis Reproductive Health, a non-profit organization that supported the approval, commented, “This is really a transformation in access to contraceptive care. Hopefully, this will help people overcome those barriers that exist now.” Perrigo, based in Ireland, has not yet announced the price for Opill. Over-the-counter medicines are generally less expensive than prescription drugs, but they are not covered by insurance.
In recent decades, many common medications, including those for pain, heartburn, and allergies, have made the switch to non-prescription status. Perrigo provided years of research to the FDA to demonstrate that women could understand and follow the instructions for using the pill. The FDA’s approval for Opill came despite some concerns from its scientists regarding the company’s results, including whether women with certain underlying medical conditions would comprehend that they should not take the drug.
It should be noted that the FDA’s decision only applies to Opill. This particular pill belongs to an older class of contraceptives known as minipills, which contain a single synthetic hormone and generally have fewer side effects compared to more popular combination hormone pills. Women’s health advocates, however, hope that this decision will pave the way for more over-the-counter birth control options. They also express the hope that abortion pills will eventually have the same accessibility.
It is important to clarify that the FDA’s decision regarding Opill has no connection to the ongoing legal battles over the abortion pill mifepristone. The studies included in Perrigo’s FDA application began years before the Supreme Court’s reversal of Roe v. Wade, which has significantly impacted abortion access in the U.S.
Given the current curtailment of reproductive rights in some states, the FDA has faced pressure from Democratic politicians, health advocates, and medical professionals to improve access to birth control. Both the American Medical Association and the leading professional society for obstetricians and gynecologists supported Opill’s application for over-the-counter status. An external panel of FDA advisers unanimously voted in favor of the switch during a hearing in May, where numerous speakers called for Opill’s approval. Dyvia Huitron, a 19-year-old University of Alabama student, was among those who spoke, sharing her experience of being unable to obtain prescription birth control. Huitron explained that she is uncomfortable getting a prescription due to the school’s health system reporting medical exams and medications to parents. “My parents did not let me go on the pill,” Huitron said. “There was just a lot of cultural stigma around being sexually active before you’re married.” While she uses other forms of contraception, she expressed a preference for having the option of birth control alongside additional methods to ensure maximum safety.
Advocates for Youth, one of the many groups supporting increased accessibility to prescription contraceptives, provided funding for some of the studies submitted for Opill. They also encouraged HRA Pharma, which later became Perrigo, to submit its application to the FDA. Opill was of particular interest to advocates because it raised fewer safety concerns. Although the pill was first approved in the U.S. five decades ago, it has not been marketed in the country since 2005. Blanchard, from Ibis Reproductive Health, pointed out, “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.”
Newer birth control pills typically combine two hormones, estrogen and progestin, which can help regulate periods. However, their use carries a higher risk of blood clots and is not recommended for women at risk of heart problems, such as smokers over the age of 35. Opill contains only progestin, which prevents pregnancy by blocking sperm from reaching the cervix. It must be taken at the same time every day for maximum effectiveness.
During the FDA’s internal review published in May, it was noted that some women in Perrigo’s study struggled to understand the drug’s labeling information. The instructions caution against taking the pill for women with a history of breast cancer, as it may stimulate tumor growth. Women experiencing unusual vaginal bleeding are advised to consult a doctor first, as it may indicate a medical problem.
Perrigo executives have stated that they will spend the remainder of the year manufacturing the pill and its packaging, with plans for nationwide distribution and online availability by early next year.