The Food and Drug Administration (FDA) has recently approved the first birth control pill to be sold without a prescription in the United States. Opill, manufactured by Perrigo Company, will soon be available over the counter and is expected to significantly increase access to contraception. This move is especially beneficial for young women, teenagers, and those who face barriers in obtaining prescriptions, such as time, costs, or logistical challenges.
Opill is set to become the most effective nonprescription birth control option available, surpassing condoms, spermicides, and other similar methods. The pill will be identical to the prescription version that has been in use for 50 years and is 93% effective in preventing pregnancy with typical use.
While the exact cost of the medication has not yet been disclosed by Perrigo, the company has expressed its commitment to making Opill affordable and accessible to women of all ages. They have also stated that a consumer assistance program will be launched to provide the pill free of charge to some women.
The approval of over-the-counter birth control pills comes at a time when the accessibility of contraception has become increasingly crucial. This development has received widespread support from various reproductive health specialists and organizations like the American Medical Association, the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians. A survey conducted by the health care research organization KFF revealed that over three-quarters of women of reproductive age are in favor of over-the-counter birth control pills due to the convenience it offers. Approximately 40% of the respondents expressed their likelihood of using it.
Interestingly, despite the ongoing abortion debate, many anti-abortion groups have refrained from criticizing over-the-counter birth control. Catholic organizations and Students for Life Action have shown opposition, while others have recognized the importance of expanding access to contraception.
The decision to approve Opill followed a unanimous vote by a panel of 17 independent scientific advisers to the FDA. These experts, including obstetrician-gynecologists, adolescent medicine specialists, and public health professionals, agreed that the benefits of making the birth control pill available without a prescription outweighed the risks. They stressed the urgent need for an over-the-counter option in a country where nearly half of all pregnancies are unintended.
Affordability remains a significant concern for advocates of over-the-counter birth control pills. While the Affordable Care Act requires health insurance plans to cover prescription contraception, the coverage does not extend to nonprescription methods. Although some states have laws mandating the coverage of over-the-counter birth control, most states do not. A recent executive order by President Biden may pave the way for the federal government to require insurers to cover over-the-counter birth control. Senate Democrats have also reintroduced legislation for mandatory coverage.
Opill, also known as a mini pill, contains only one hormone, progestin, unlike combination pills that contain both progestin and estrogen. Cadence Health, a company that manufactures combination pills, is also in discussions with the FDA regarding over-the-counter status for its product.
The FDA analysts evaluating Perrigo’s application expressed concerns about the ability of women with medical conditions, such as breast cancer and undiagnosed vaginal bleeding, to follow the warnings and avoid using the product. They also raised questions about the comprehension of younger adolescents and individuals with limited literacy when it comes to following the medication’s instructions. However, the panelists noted that patients with breast cancer are typically advised by their doctors to avoid birth control pills, and Opill might be the safest option for adolescents, given their low likelihood of having breast cancer. Moreover, easy access to a more effective method than condoms and other retail-bought birth control products is crucial for young people who often start their contraceptive journey with over-the-counter options.
Perrigo reported that participants in a study took Opill on 92.5% of the prescribed days. Even when participants missed a pill, most of them followed the label’s directions by taking mitigating steps, such as abstaining from sex or using a condom. Out of 955 participants, only six became pregnant while using Opill.
In conclusion, the FDA’s approval of the first over-the-counter birth control pill in the United States is a significant step toward expanding access to contraception. Opill, manufactured by Perrigo, will soon be available without a prescription, providing a convenient and effective option for women. The availability of over-the-counter birth control pills addresses the pressing issue of affordability and ensures that more women can access contraception without financial constraints. While concerns were raised regarding the ability of certain individuals to follow warnings and instructions, experts and panelists overwhelmingly supported the availability of over-the-counter birth control, emphasizing its potential positive impact on public health.
