FDA Approves Over-the-Counter Birth Control Pill, Expanding Access to Contraception
The Food and Drug Administration (FDA) has granted approval for the sale of a birth control pill without a prescription, marking a significant milestone for contraception accessibility in the United States. The pill, named Opill, is expected to be the most effective over-the-counter birth control method, surpassing the efficacy of condoms, spermicides, and other nonprescription options. Experts believe that this development will be particularly beneficial for young women, teenagers, and those facing difficulties in obtaining a prescription due to various reasons.
Perrigo Company, the manufacturer of Opill based in Dublin, has announced that the pill will likely be available in stores and online retailers in the US by early 2024. However, the company has not disclosed the cost of the medication, which will play a crucial role in determining its utilization. Perrigo’s global vice president for women’s health, Frédérique Welgryn, stated that the company is committed to ensuring the pill’s accessibility and affordability for women of all ages. Additionally, Perrigo is planning to launch a consumer assistance program to provide the medication free of charge to some women.
Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, described the approval as a significant moment that will provide millions of Americans with access to a nonprescription daily oral contraceptive option. When used as directed, the pill is expected to be safer and more effective in preventing unintended pregnancies than currently available nonprescription methods.
The increased availability of contraception has become an urgent issue, particularly since the Supreme Court’s decision to overturn the national right to an abortion last year. Even prior to this ruling, the call to make nonprescription birth control available to individuals of all ages had garnered widespread support from reproductive and adolescent health specialists, along with organizations like the American Medical Association, the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians.
A survey conducted by healthcare research organization KFF last year revealed that over three-quarters of reproductive-age women favored over-the-counter birth control due to its convenience. Almost 40 percent of the respondents expressed their likelihood of using it. The survey also found that women already using birth control pills, those without health insurance, and Hispanic women were particularly inclined to opt for this option.
Surprisingly, despite the divisive issue of abortion, many anti-abortion groups have refrained from criticizing over-the-counter birth control. Opposition primarily stems from certain Catholic organizations and Students for Life Action.
In May, a panel of 17 independent scientific advisers to the FDA, including experts in obstetrics and gynecology, voted unanimously in favor of making a birth control pill available without a prescription. They deemed the benefits of increased accessibility to outweigh the risks. Opill, which received approval for prescription use 50 years ago, is expected to be identical to its nonprescription version, offering 93 percent effectiveness in preventing pregnancy with typical use.
Affordability is a major concern for proponents of over-the-counter pills. The Affordable Care Act currently mandates health insurance plans to cover prescription contraception but not over-the-counter methods. Although some states have laws requiring coverage for over-the-counter birth control, most do not. The KFF survey indicated that 10 percent of women would be unable or unwilling to pay any out-of-pocket costs for contraception. About 40 percent would pay $10 or less per month, while a third would pay $20 or less.
President Biden’s recent executive order could lead to federal requirements for insurers to cover over-the-counter birth control. Senate Democrats have also reintroduced legislation to enforce such coverage. Senator Patty Murray, the lead sponsor of the bill, emphasized the importance of affordability and availability to ensure equity, particularly for low-income women.
Opill, also known as the “mini pill” due to containing only progestin, unlike combination pills that contain both progestin and estrogen, exhibits a minimal risk for individuals who read and follow the labeling. Concerns were raised about individuals who should not take hormonal contraception, such as those with breast cancer or undiagnosed vaginal bleeding, but it was determined that the probable public health impact of preventing unintended pregnancies outweighed the potential harms.
Opill was used correctly by participants in a study on 92.5 percent of the prescribed days. Those who missed a pill reported following mitigation instructions on the label, such as abstaining from sex or using condoms. Only six of the 955 participants became pregnant while using Opill. The results highlight the potential reduction in adherence barriers that could be addressed by making the pill available over the counter.