Perrigo Co.’s Opill received U.S. 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 U.S. 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.
Birth control and reproductive health have risen to the top of the legislative and political agenda since the Supreme Court overturned the Roe v. Wade ruling that guaranteed a constitutional right to abortion for about 50 years. President Joe Biden has made reproductive rights a key feature of his 2024 reelection bid, casting Republican positions on abortion and contraception as extreme.
Doctors and advocacy groups praised the FDA decision. The American Medical Association urged regulators to consider applications for other available oral contraceptives to be used over-the-counter.
“Birth control is essential health care,” Alexis McGill Johnson, Chief Executive Officer of Planned Parenthood Federation of America, said in a statement. “We are thrilled to see the FDA follow the science and remove an unnecessary barrier to accessing basic health care.”
Early 2024
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.
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 1.5% at 12:51 p.m. in New York.
Almost half of the 6.1 million annual U.S. 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
Drugstore chain Rite Aid Corp. said it’s reviewing the FDA’s action and evaluating its OTC offerings. Rivals Walgreens Boots Alliance Inc. and CVS Health Corp. didn’t respond to questions about carrying Opill. Retailers Walmart Inc., Target Corp. and Amazon.com Inc. and grocer Kroger Co., also didn’t 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.
In May, a group of democratic senators reintroduced a bill that would require insurers to fully cover over-the-counter birth control options without any fees or out-of-pocket costs once the FDA determines them to be safe for use. 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’s Dobbs v. Jackson Women’s Health Organization decision that curbed access to abortion in some parts of the country.
Last month, Biden 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 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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(With assistance from Brendan Case and Matt Day)
