The FDA Just Approved Opill, the First Over-the-Counter Birth Control Pill!
On Thursday, the Food and Drug Administration (FDA) approved pharmaceutical company Perrigo’s Opill, the first over-the-counter birth control pill, which will let individuals obtain the contraceptive without a prescription from a doctor.
“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,” announced Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, in a news release. “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.”
BREAKING: The FDA has approved the first over-the-counter birth control pill, allowing Americans to buy a daily oral contraceptive without a prescription. https://t.co/ed4h9shwG2
— CBS News (@CBSNews) July 13, 2023
In the wake of the groundbreaking legislative feat, here’s what you need to know about Opill, including when it will be in pharmacy aisles and what makes it different from other forms of birth control.
First thing: Why is this a big deal?
It’s simple: The FDA permitting Perrigo’s once-a-day Opill to be sold without a prescription makes it the first daily oral contraceptive of its kind to be available in pharmacy aisles instead of behind the counter.
What exactly is Opill?
Opill falls under a class of contraceptives that are sometimes referred to as “mini-pills.” This particular birth control pill contains a single synthetic hormone—progestin—and generally carries fewer side effects than more contemporary combination hormone pills, which typically combine two hormones—estrogen and progestin—for the purpose of making periods more regular and less heavy.
When can I buy Opill?
Perrigo won’t start shipping the pill until early 2024. There reportedly will not be age restrictions on sales—another added benefit of the approval!
How much will Opill birth control cost?
Perrigo has not announced a price for the Opill just yet. However, in general, over-the-counter medication tends to be cheaper than prescription ones. The one caveat is they typically aren’t covered by insurance, so it’s unclear what Opill’s final price tag will be.
According to the Associated Press, there are already reformers working on ensuring the cost is fair: “Forcing insurers to cover over-the-counter birth control would require a regulatory change by the federal government, which women’s advocates are urging the Biden administration to implement.”
Are there any downsides to Opill?
Like many medications on the market, it is important to consider that not everything is a one-size-fits-all solution. That said, the Opill is a giant step in the right direction for reproductive rights. Per the Associated Press, in order to get this pill approved, Perrigo submitted “years of research to FDA to show that women could understand and follow instructions for using the pill.” Even so, there were still reportedly “concerns by FDA scientists about the company’s results, including whether women with certain underlying medical conditions would understand they shouldn’t take the drug.”
Similar to other birth control options on the market, Opill carries a heightened risk of blood clots, and women at risk for heart problems should be cautious. Additionally, because Opill is a progestin-only pill, it may have a reduced effectiveness if it is not taken at the same time each day.
All things considered, Perrigo executives have insisted the company will spend the rest of the year before Opill’s availability goes into effect reworking its packaging to ensure that all its side effects and usage instructions are crystal clear in time for it to hit pharmacy shelves early next year.
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