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First Over-the-Counter Birth Control Pill Approved by US Regulators

First Over-the-Counter Birth Control Pill Approved by US Regulators
Pro-abortion activists rally near the Supreme Court as they protest the annual March for Life on the National Mall in Washington, DC, USA, 20 January 2023. (Photo: EPA-EFE / Shawn Thew)

Perrigo Co.’s Opill received US clearance as the first daily oral birth-control product available without a prescription, coming at a time when reproductive rights are increasingly under fire.

The decision released Thursday by the US Food and Drug Administration widens access to the drug by removing barriers to obtaining oral contraception, such as inability to get a doctor’s appointment.

Perrigo expects Opill to be available for consumers to purchase over-the-counter by early 2024, Frédérique Welgryn, global vice president for women’s health, said on a call with reporters. The shares rose as much as 5.8% as of 10:59 a.m. in New York, the most intraday since May 10.

While Americans have had access to Opill with a prescription since 1973, reproductive rights advocates have long argued that oral contraception should be available over the counter, as is the case in more than 100 countries. The nonprescription version has the potential to allow women to get access to birth control without intervention from potential gatekeepers, like doctors and parents.

Read More about Opill:

FDA Raises Doubts About Perrigo’s Over-Counter Birth Control 

One Way to Boost Access to Birth Control: Skip the Prescription

Over-the-Counter Birth-Control Pills Face Challenges in the US

Almost half of the 6.1 million annual US pregnancies are unintended, according to the FDA. That reduces the likelihood of receiving early prenatal care while raising the risk of pre-term delivery and other adverse health outcomes for parents and children.

Still, the price of the drug remains unknown and may be an obstacle for some users. Perrigo said earlier this year it is dedicated to making the drug affordable and is looking into creating a program that would allow some people to get the pill free of charge. In July, a spokesperson for Perrigo said that details of pricing would likely come in the coming months after approval for OTC use, as “the company needs to talk to retailers and build those plans out.”

Safety Profile

Walgreens Boots Alliance Inc., CVS Health Corp. and Rite Aid Corp. didn’t immediately respond to questions about whether the drugstore chains plan to carry Opill in their pharmacies. Retailers Walmart Inc., Target Corp. and Inc. and grocer Kroger Co., also didn’t immediately respond to emailed questions.

Perrigo is working to get the drug listed with private insurers and Medicaid, Welgryn said. While insurers are required to cover prescription birth control, there’s no such mandate for over-the-counter versions. Advocates have said coverage is necessary in order to make the drug more accessible to those who need it. Perrigo said it has some “work to do to make that happen.”

Despite its strong safety profile, regulators have required a prescription for oral birth control so that doctors can screen patients with medical conditions that may be aggravated by hormones in the drugs. For example, one type of oral birth control contains the estrogen and progestin, hormones associated with side effects such as serious blood clots in certain populations.

Opill contains only progestin, and research has shown it doesn’t raise clotting risk. It isn’t recommended for people with certain conditions like breast cancer or liver disease, and shouldn’t be used together with another hormonoal birth control product.

Executive Order

For six years, nonprofit Ibis Reproductive Health and HRA Pharma, a unit of Perrigo, collaborated on research needed to make a case for selling Opill without a prescription. Perrigo sought FDA approval for an over-the-counter version last summer after the Supreme Court overturned the landmark Roe v. Wade ruling, curbing access to abortion in some parts of the country.

President Joe Biden has made reproductive rights a key feature of his 2024 reelection bid, casting Republican positions on abortion and contraception as extreme. Last month, he issued an executive order directing agencies to promote increased access to over-the-counter contraception, while supporting improved access and affordability for people with both private and government coverage.

The White House didn’t immediately respond to a request for comment on the FDA decision. Meanwhile, Health and Human Services Secretary Xavier Becerra applauded the milestone.

“For women, this approval will lower longstanding barriers to the health care they need,” he said in a statement.


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