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

by Madison Thomas
1 comment
over-the-counter birth control pill

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.

Follow Matthew Perrone on Twitter: @AP_FDAwriter

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.

Frequently Asked Questions (FAQs) about over-the-counter birth control pill

Q: What is the significance of the FDA approval for the over-the-counter birth control pill?

A: The FDA approval for the over-the-counter birth control pill is a landmark decision that allows American women and girls to easily obtain contraceptive medication without a prescription. It aims to improve access to contraception and address the high rate of unintended pregnancies in the United States.

Q: When will the over-the-counter birth control pill be available for purchase?

A: The manufacturer, Perrigo, plans to start shipping the pill, known as Opill, in early next year. However, specific availability dates may vary, so it’s advisable to check with pharmacies and retailers for updates.

Q: Will there be any age restrictions on the purchase of the over-the-counter birth control pill?

A: No, there will be no age restrictions on the sales of the over-the-counter birth control pill. This means that women and girls of all ages will have access to the contraceptive medication without needing a prescription.

Q: What are the benefits of having an over-the-counter birth control pill?

A: The availability of an over-the-counter birth control pill improves convenience and access to contraception. It eliminates the need for doctor’s appointments, prescriptions, and potential barriers like cost, time off work, and finding childcare. This broader access empowers individuals to take control of their reproductive health and make informed choices.

Q: How does the price of the over-the-counter birth control pill compare to prescription options?

A: The price of the over-the-counter birth control pill, Opill, has yet to be announced by Perrigo. However, over-the-counter medications generally tend to be more affordable compared to prescription options. It is important to consider the potential cost and affordability of the pill when it becomes available.

Q: Does insurance cover the cost of the over-the-counter birth control pill?

A: Typically, over-the-counter medications are not covered by insurance. As a result, the cost of the over-the-counter birth control pill may not be reimbursed by insurance plans. However, there have been calls for regulatory changes to require insurance coverage for over-the-counter birth control, but such changes would require action by the federal government.

Q: Are there any side effects or safety concerns associated with the over-the-counter birth control pill?

A: The over-the-counter birth control pill, Opill, contains only progestin and generally carries fewer side effects compared to combination hormone pills. However, common side effects may include bleeding, headaches, dizziness, and cramps. It is essential to carefully read and follow the instructions provided with the pill. Certain medical conditions and medications may interfere with its effectiveness, so it is advisable to consult a healthcare professional if needed.

Q: Does the FDA approval of the over-the-counter birth control pill affect access to abortion pills?

A: No, the FDA approval of the over-the-counter birth control pill, Opill, is unrelated to the ongoing court battles over abortion pills. While the decision expands contraceptive options, it does not directly impact the availability or regulations surrounding abortion pills. The approval focuses specifically on contraception rather than abortion-related medications.

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1 comment

HealthNerd123 July 14, 2023 - 11:06 am

Finally, FDA approvz the OTC birth control pill. it’s a big deal 4 women’s repro health n reducing unplanned preg. bt i wnder how many pple can afford it, insuranc shud covr it. gov needs 2 step up!


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