Packaging for the daily birth control pill Opil is seen in an undated illustration.

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The first birth control pill sold without a prescription may remain out of reach for some women and girls in the United States because health insurance plans are not required to cover the over-the-counter drug.

The U.S. Food and Drug Administration on Thursday approved the sale of the oral contraceptive Opil without a prescription, a historic decision that should make the pill more accessible by eliminating the need to visit a doctor’s office and refill a prescription.

According to a 2016 survey published in the Journal of Women’s Health, one-third of adult women who have tried to obtain prescription contraceptives face barriers to access.

Manufacturer of Ofir Perigo The drug is expected to be available in major stores and online in early 2024. Perrigo executive Frederique Welgryn said in a conference call with reporters on Thursday that Perrigo will announce the price of Opil months before the drug becomes available.

Welgryn said the company is committed to making sure Opil is affordable. Perrigo is working on a patient assistance program so that the price of the drug doesn’t become a barrier for women struggling to make ends meet.

But some women and girls may still face barriers to accessing Opil. The Affordable Care Act does not require private health insurance to cover the cost of pills used without a prescription. Most health insurance companies are required to provide birth control at no cost with a doctor’s prescription.

State Medicaid programs also generally aren’t required to cover drugs sold without a prescription, according to the Centers for Medicare and Medicaid Services.

Perrigo is committed to the insurance business

Welgreen said Perrigo is fighting to get private insurance and the state Medicaid program to provide free over-the-counter medications for women and girls. But she said the Affordable Care Act needs to be tweaked to guarantee that health insurance pays for birth control without a prescription.

Welgryn said it was unclear whether coverage would be available for the Opil pills when they hit stores early next year. “We need to do some work to make this happen. It will take time,” she said.

Congressional Democrats and President Joe Biden are pushing to expand access to contraceptives.

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Sen. Patty Murray, D-Washington, reintroduced legislation in the Senate in May called “Affordability Is Accessibility,” which would require health insurers to provide free over-the-counter oral contraceptives.

Biden in June ordered the U.S. Department of Health and Human Services to ensure that all FDA-approved contraceptives are free of out-of-pocket fees.

A CMS spokesperson said Friday that the agency is encouraging health insurance to cover over-the-counter birth control products at no cost. The agency is looking at how to ensure that FDA-approved over-the-counter contraceptives are available without cost-sharing, the spokeswoman said.

Opil is 93% effective in contraception. It is the most effective over-the-counter birth control pill in the United States and should be taken at the same time each day to ensure its effectiveness.

According to Welgryn, 15 million women in the United States who are sexually active but do not want to become pregnant are using birth control that is not as effective as Opill, or is not using any birth control at all.

According to the FDA, nearly half of the 6 million pregnancies a year in the United States are unintended. Unplanned pregnancies are linked to premature births, which can lead to poor health in newborns, the agency said.

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