Perrigo Co.’s Opill received U.S. clearance for over-the-counter use, making it the first daily oral birth-control product to be available without a prescription in the U.S.
The decision released Thursday by the U.S. Food and Drug Administration widens access to the drug by removing substantial barriers to obtaining oral contraception, such as inability to get a doctor’s appointment.
Shares of Perrigo rose as much as 5.8% at the New York market open, 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. However, the price of the drug 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 emailed questions about whether the drugstore chains plan to carry Opill in their pharmacies.
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.
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.
Executive Order
“This decision will mean people across the U.S. will have a new and easier way to access oral contraceptives, potentially transforming contraceptive access and reproductive health,” Kelly Blanchard, President of Ibis Reproductive Health, which houses Free the Pill, said in a statement.
The White House didn’t immediately respond to a request for comment. Last month, the Biden administration issued new rules to expand and protect the availability contraception under federal programs. The executive order directed agencies to promote increased access to over-the-counter contraception, while also supporting improved access and affordability for people with both private insurance and government coverage through Medicaid and Medicare.
Perrigo’s product has the “potential to radically transform women’s access to contraception,” Chief Executive Officer Patrick Lockwood-Taylor said in a statement announcing the approval.
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(With assistance from Riley Griffin)
