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  5. You'll now be able to get birth control without a prescription — but it won't hit store shelves until 2024

You'll now be able to get birth control without a prescription — but it won't hit store shelves until 2024

Associated Press   

You'll now be able to get birth control without a prescription — but it won't hit store shelves until 2024
  • The FDA approved the first over-the-counter birth control pill.
  • Starting in 2024, Perrgio's once-a-day OPill will be available without a prescription.

U.S. officials have approved the first over-the-counter birth control pill, which will let American women and girls buy contraceptive medication from a retail store without a prescription.

The Food and Drug Administration said Thursday it cleared Perrigo's once-a-day Opill to be sold without a prescription, making it the first such medication to be moved out from behind the pharmacy counter.

The company won't start shipping the pill until early next year, and there will be no age restrictions on sales.

Hormone-based pills have long been the most common form of birth control in the US, used by tens of millions of women since the 1960s. Until now, all of them required a prescription.

Medical societies and women's health groups have pushed for wider access, noting that an estimated 45% of the 6 million annual pregnancies in the US are unintended. Teens and girls, women of color and those with low incomes report greater hurdles in getting prescriptions and picking them up.

Ireland-based Perrigo did not announce a price. Over-the-counter medicines are generally much cheaper than prescriptions, but they aren't covered by insurance.

Perrigo submitted years of research to the FDA to show that women could understand and follow instructions for using the pill. Thursday's approval came despite some 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.
FDA's action only applies to Opill — not other birth-control pills.

It's in an older class of contraceptives, sometimes called mini pills, that contain a single synthetic hormone and generally carry fewer side effects than more popular combination hormone pills.

But women's health advocates hope the decision will pave the way for more over-the-counter birth control options and, eventually, for abortion pills to do the same.

That said, FDA's decision has no relation to the ongoing court battles over the abortion pill mifepristone. The studies in Perrigo's FDA application began years before the Supreme Court's reversal of Roe v. Wade, which has upended abortion access across the US.

Newer birth control pills typically combine two hormones, estrogen and progestin, which can help make periods lighter and more regular. But their use carries a heightened risk of blood clots and they shouldn't be used by women at risk for heart problems, such as those who smoke and are over 35.

Opill has only progestin, which prevents pregnancy by blocking sperm from reaching the cervix. It must be taken around the same time daily to be most effective.

In its internal review published in May, the FDA noted that some women in Perrigo's study had trouble understanding the drug's labeling information. In particular, the instructions warn that women with a history of breast cancer should not take the pill because it could spur tumor growth. And women who have unusual vaginal bleeding are instructed to talk to a doctor first because it could indicate a medical problem.

Perrigo executives said the company will spend the rest of the year manufacturing the pill and its packaging so it can be available in stores nationwide and online by early next year.


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