WASHINGTON—For the first time, a pharmaceutical company has asked for permission to sell a birth control pill over the counter in the U.S.
An FDA approval could come next year and would only apply to HRA’s pill, which would be sold under its original brand name, Opill. The company acquired the decades-old drug from Pfizer in 2014, but it's not currently marketed in the U.S. Many conservative groups stress they are only interested in curtailing abortion, and state bans often explicitly exclude contraception.
In each case, companies must show that consumers can understand the drug's labeling, evaluate its risks and use it safely and effectively without professional supervision. HRA spent seven years conducting the FDA-required studies, including a trial that followed 1,000 women taking its pill for six months.
Birth control pills are available without a prescription across much of South America, Asia and Africa. Last year, Paris-based HRA won U.K. approval for the first birth control pill available there without a prescription. But estrogen also accounts for most of the blood clot risk associated with oral contraceptives. FDA's labeling warns against their use in certain women already at risk for heart problems, such as those who smoke and are over 35.
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