Landmark FDA Approval: First Over-the-Counter Birth Control Pill

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In a significant milestone decision, federal regulators granted approval on Thursday for the first over-the-counter birth control pill in the United States. This landmark decision will soon enable American women and girls to easily obtain contraceptive medication, just as they would purchase aspirin or eyedrops.

The Food and Drug Administration (FDA) has authorized the sale of Opill, a once-a-day pill, without the need for a prescription. This move marks the first time a contraceptive medication has been made available without being placed behind the pharmacy counter. The manufacturer, Perrigo, based in Ireland, plans to start shipping the pill in early next year, and there will be no age restrictions on its sales.

For decades, medical societies and women’s health groups have advocated for broader access to birth control. They emphasize that approximately 45% of the 6 million pregnancies in the U.S. each year are unintended. Obtaining prescriptions and picking them up pose greater challenges for teenagers, women of color, and those with low incomes. These hurdles include financial constraints, difficulty scheduling doctor’s appointments, taking time off work, and arranging for childcare.

Kelly Blanchard, president of Ibis Reproductive Health, a nonprofit organization that supported the approval, described the FDA’s decision as a transformative step toward improving access to contraceptive care. She expressed hope that this move would help individuals overcome existing barriers.

Perrigo states that Opill could be a significant new option for the estimated 15 million women in the U.S. who currently use no form of birth control or rely on less effective methods like condoms. This group represents approximately one-fifth of women of child-bearing age.

However, the extent of women’s access to Opill depends on its price, which Perrigo plans to announce later this year. Dr. Pratima Gupta from the American College of Obstetricians and Gynecologists emphasized that the motivation behind advocating for over-the-counter birth control pills was to improve access and eliminate cost as a barrier.

While prescription birth control pills typically cost $15 to $30 per month without insurance coverage, over-the-counter medicines are generally less expensive but not covered by insurance. Advocates for women’s health are urging the Biden administration to implement regulatory changes that would require insurers to cover over-the-counter birth control.

The FDA’s approval of Opill offers American women another birth control option in the midst of ongoing legal and political battles concerning reproductive health. The decision is unrelated to the contentious court battles surrounding the abortion pill mifepristone. It is important to note that anti-abortion groups generally do not oppose contraceptives, which aim to prevent pregnancies rather than terminate them.

Nevertheless, concerns persist that contraception could become a target in the future. Justice Clarence Thomas, in a separate opinion following the Supreme Court’s overturning of Roe v. Wade, explicitly called for reconsideration of the court’s decisions on same-sex marriage, gay sex, and contraception cases. Despite this, the approval of Opill does not directly impact the ongoing court battles.

Over the past year, the FDA has faced pressure from Democratic politicians, health advocates, and medical professionals to enhance access to birth control. Leading medical groups, including the American Medical Association, supported Opill’s application for over-the-counter status.

It is worth noting that birth control pills are available without a prescription across much of South America, Asia, and Africa. Perrigo submitted years of research to the FDA, demonstrating that women can understand and follow instructions for using the pill. Despite some concerns raised by FDA scientists about the company’s results, including the comprehension of certain women with underlying medical conditions regarding the pill’s use, the approval was granted.

Opill belongs to an older class of contraceptives known as minipills, containing a single synthetic hormone. These pills generally have fewer side effects than the more commonly used combination hormone pills. However, women’s health advocates view this decision as a stepping stone towards broader availability of over-the-counter birth control options and, potentially, abortion pills.

In May, an external panel of FDA advisers unanimously voted in favor of allowing Opill to be sold over the counter. During the hearing, numerous public speakers called for the approval of Opill, including Dyvia Huitron, a 19-year-old University of Alabama student who shared her difficulties in obtaining prescription birth control due to cultural stigma and concerns about parental notification.

Advocates were particularly interested in Opill due to its lower safety concerns. The pill has been approved for use in the United States for the past five decades, providing a substantial amount of data supporting its safety and effectiveness for over-the-counter use.

Opill contains only progestin, which prevents pregnancy by obstructing sperm from reaching the cervix. To maximize effectiveness, it must be taken at approximately the same time each day.

The FDA’s internal review, published in May, highlighted some challenges experienced by women in understanding the drug’s labeling information during Perrigo’s study. Specifically, the instructions caution against the pill’s use by women with a history of breast cancer, as it may stimulate tumor growth.

Common side effects of Opill include bleeding, headaches, dizziness, and cramps. The label also warns that certain medications, such as those for seizures, HIV, and hypertension, can interfere with Opill’s effectiveness.

Perrigo intends to spend the remainder of the year manufacturing Opill, ensuring its availability in stores early next year.

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Follow Matthew Perrone on Twitter: @AP_FDAwriter

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The Big Big News Health and Science Department is supported by the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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• FDA approves first over-the-counter birth control pill
• Perrigo
• American College of Obstetricians and Gynecologists
• Roe v. Wade
• American Medical Association
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• Howard Hughes Medical Institute