FDA Approves Opill: First Over-the-Counter Birth Control Pill in the US

FDA Approves Over-the-Counter Birth Control Pill in Milestone Decision

In a groundbreaking move, the Food and Drug Administration (FDA) has granted approval for a birth control pill to be sold without a prescription in the United States. This decision marks a significant milestone that could greatly increase access to contraception across the nation. The medication, known as Opill, will become the most effective over-the-counter birth control method available, surpassing condoms, spermicides, and other nonprescription options. Reproductive health experts believe that this accessibility will be particularly beneficial for young women, teenagers, and individuals who face challenges in obtaining a prescription due to factors such as time, cost, or logistical difficulties.

Perrigo Company, the manufacturer of Opill based in Dublin, has announced that the medication will likely be available for purchase from stores and online retailers in the United States by early 2024. While the cost of the pill has not been disclosed, Perrigo’s Vice President for Women’s Health, Frédérique Welgryn, has stated that the company is dedicated to making Opill “accessible and affordable to women and people of all ages.” Perrigo plans to implement a consumer assistance program to provide the pill at no cost to certain women.

Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, expressed the significance of this approval, stating, “Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States. When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.”

The accessibility of contraception has become an increasingly urgent issue, particularly in light of the Supreme Court’s decision to overturn the national right to an abortion last year. However, even before this ruling, the idea of making a nonprescription birth control pill available to individuals of all ages had garnered widespread support from reproductive and adolescent health specialists, as well as organizations like the American Medical Association, American College of Obstetricians and Gynecologists, and American Academy of Family Physicians.

In a survey conducted by the health care research organization KFF, it was found that over three-quarters of women of reproductive age expressed favorability towards an over-the-counter pill due to its convenience. Nearly 40 percent of respondents stated that they would likely use such a pill. The survey also revealed that women who were already using birth control pills, uninsured women, and Hispanic women were among those most likely to consider using an over-the-counter option.

While the approval of Opill has been widely supported, it is essential to address concerns of affordability. The Affordable Care Act currently requires health insurance plans to cover prescription contraception, but over-the-counter methods do not receive the same coverage. However, under a recent executive order by President Biden, the federal government may soon take steps to require insurers to cover over-the-counter birth control. Senate Democrats have also reintroduced legislation to enforce such coverage and ensure affordability.

Opill is categorized as a “mini pill” as it contains only one hormone, progestin, unlike combination pills that consist of both progestin and estrogen. The FDA has also been in discussions with Cadence Health, the manufacturer of a combination pill, regarding applying for over-the-counter status.

Though concerns were raised by FDA analysts regarding the use of Opill by individuals who should avoid birth control pills due to medical conditions such as breast cancer and undiagnosed vaginal bleeding, the overall acceptance of the pill outweighed the risks. Advisory committee members emphasized the pressing public health need for an over-the-counter option since nearly half of all pregnancies in the country are unintended.

Opill’s approval opens up new possibilities for individuals seeking accessible and effective contraception. As the medication becomes available over the counter, efforts must be made to address affordability issues and ensure that it is accessible to all individuals who can benefit from it. This significant step forward may pave the way for increased reproductive healthcare options and could have a substantial positive impact on public health.