First over-the-counter birth control pill approved in the US

Food and Drug Administration

The US Food and Drug Administration has given the green light for Opill, an oral contraceptive, to be sold without a prescription. It marks the groundbreaking occasion of the very first hormonal contraceptive to be accessible over the counter in the United States.

Food and Drug Administration - Figure 1
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A birth control pill will be accessible over-the-counter for the first time ever in the United States.

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The United States Food and Drug Administration has given its approval for the first birth control pill to be sold over-the-counter, meaning it can now be purchased without a prescription. The announcement, made on July 13th, is expected to greatly enhance the availability of contraception in the United States.

At present, in the United States, individuals are only able to obtain hormonal contraceptives by acquiring a prescription, a process that typically necessitates a visit to a healthcare professional. This can pose challenges for individuals without health insurance, those residing in remote regions, or individuals with limited availability to visit a clinic. An examination conducted in 2016 discovered that approximately one-third of women in the US who stated their attempts to acquire a prescription or refill for hormonal birth control encountered difficulties in doing so.

A brand-new contraceptive pill called Opill will hit the shelves of pharmacies, convenience stores, and online sellers in the US during the beginning of next year. It's essential to note that this approval exclusively pertains to Opill and does not extend to other forms of hormonal birth control.

Opill was initially authorized for prescription use by the authorities in 1973. When used as directed, it is successful in preventing 93% of pregnancies. In contrast, over-the-counter contraceptives like condoms and spermicides offer effectiveness rates ranging from 79% to 87%.

Patrizia Cavazzoni from the FDA stated that when taken as instructed, daily oral contraception is deemed safe and likely to be more efficient in preventing unintended pregnancy compared to the contraceptive methods currently available without a prescription.

The FDA reports that nearly half of the 6.1 million pregnancies that occur in the United States every year are not intended. These unintended pregnancies have been linked to worse health outcomes for both mothers and children when compared to planned pregnancies. These outcomes include increased instances of pre- and postpartum depression, domestic abuse, and premature birth.

In a statement, Frédérique Welgryn from Perrigo Company, the manufacturer of the drug based in Dublin, expressed that the approval granted today marks a momentous advancement for women's health in the US. Moreover, it represents a crucial step forward in addressing a prominent requirement for better availability of contraceptives.

Medical organizations such as the American Medical Association and the American College of Obstetricians and Gynecologists back the use of non-prescription hormonal birth control. However, this matter has garnered increased focus since the US Supreme Court's reversal of Roe v Wade last year, a decision that upheld the right to terminate a pregnancy.

According to a recent study conducted in 2022, over three-quarters of women of childbearing age express their backing for accessible birth control without a prescription, as long as it maintains safety and effectiveness. Additionally, approximately 40 percent of these women state their likelihood of utilizing this option if it obtains official approval.

Perrigo has yet to disclose the price of the pill, but Welgryn assured that the company is dedicated to making it reasonably priced for individuals across all age groups.

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