FDA Approves First Over-the-Counter Birth Control Pill, Set to Launch Early Next Year

**U.S. Officials Approve First Over-the-Counter Birth Control Pill**

The Food and Drug Administration (FDA) has granted approval for the first over-the-counter birth control pill in the United States. This decision allows American women and girls to purchase contraceptive medication without a prescription, making it as accessible as common medications like aspirin and eyedrops. The pill, called Opill, is manufactured by Perrigo and will be available for purchase early next year. Unlike other hormone-based birth control pills, Opill does not require a prescription, eliminating barriers for millions of women who struggled to obtain prescriptions due to various factors such as cost, time, and childcare. This historic decision is expected to revolutionize access to contraceptive care and pave the way for more over-the-counter birth control options.

**The Importance of Wider Access to Birth Control**

Considering that an estimated 45% of the 6 million pregnancies each year in the U.S. are unintended, medical societies and women’s health groups have long advocated for wider access to birth control. These groups have highlighted the challenges faced by certain demographics, such as teenagers, women of color, and those with low incomes, in obtaining prescriptions and accessing birth control. Some of these challenges include the cost of a doctor’s visit, the need for time off from work, and the difficulty of finding childcare. The FDA’s decision to make Opill available over the counter is expected to help overcome these barriers and enhance access to contraceptive care.

**Breaking Down Financial Barriers**

One significant advantage of over-the-counter medications is their affordability compared to prescription drugs. While Perrigo has not announced the price of Opill, over-the-counter medicines are generally cheaper and more accessible for consumers. However, it’s important to note that these medications are not covered by insurance. The shift towards non-prescription status for common medications has been seen in recent decades, benefiting consumers seeking relief from pain, heartburn, and allergies.

**FDA Approval and Safety Concerns**

Perrigo submitted extensive research to the FDA to demonstrate that women can understand and follow the instructions for using Opill. Despite concerns from FDA scientists regarding certain underlying medical conditions, the FDA approved the medication based on the evidence presented. Opill belongs to an older class of contraceptives known as minipills, which contain a single synthetic hormone and generally have fewer side effects than combination hormone pills. Women’s health advocates hope that this decision will pave the way for additional over-the-counter birth control options and potentially extend to abortion pills in the future.

**Separating FDA Approval from Ongoing Abortion Pill Controversies**

It is important to note that the FDA’s approval of Opill is unrelated to the ongoing legal battles surrounding the abortion pill mifepristone. The studies supporting Perrigo’s FDA application were conducted prior to the Supreme Court’s reversal of Roe v. Wade, which has significantly impacted abortion access in the U.S. However, with certain states imposing restrictions on women’s reproductive rights, there has been increasing pressure on the FDA to facilitate access to birth control. Major medical organizations, such as the American Medical Association and professional societies for obstetricians and gynecologists, supported Opill’s application for over-the-counter status.

**Public Support and Advocacy for Easier Access to Birth Control**

Opill’s path to approval was supported by numerous advocacy groups that aimed to make prescription contraceptives more accessible. These groups financially supported some of the studies submitted for Opill and encouraged Perrigo to file its application with the FDA. Opill was particularly appealing due to its favorable safety profile, having been approved in the U.S. decades ago and demonstrating a considerable amount of data supporting its safety and effectiveness for over-the-counter use. Other birth control pills that combine estrogen and progestin carry a higher risk of blood clots and are not suitable for women at risk for heart problems.

**Understanding Opill and Its Instructions**

Opill contains only progestin, which prevents pregnancy by blocking sperm from reaching the cervix. Users must take the pill around the same time daily to achieve maximum effectiveness. The FDA’s internal review highlighted some challenges in understanding the drug’s labeling information, particularly for women with a history of breast cancer or unusual vaginal bleeding. The instructions caution against using Opill if a woman has a history of breast cancer, as it may promote tumor growth. Furthermore, women with unusual vaginal bleeding are advised to consult a doctor first, as it may indicate an underlying medical issue.

**The Road Ahead for Opill**

Perrigo is currently focused on manufacturing the pill and its packaging in preparation for its nationwide availability in stores and online early next year. The introduction of over-the-counter birth control is poised to transform access to contraceptive care in the U.S. This milestone approval serves as a stepping stone towards greater accessibility and convenience in family planning and reproductive health.