The Food and Drug Administration on Thursday approved the first birth control pill to be used without a prescription, potentially expanding access to contraception in the U.S.
Called Opill, the once-daily pill will be available over the country in drug, grocery and convenience stories beginning early next year, said its maker, the Ireland-based Perrigo.
“When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy,” said Patrizia Cavazzoni, head of the primary FDA drug review office, in a statement.
Hormonal medicines have been used for decades to prevent unintended pregnancies. Norgestrel, the progestin medicine contained in Opill, was approved in the U.S. as a contraceptive in 1973, but hasn’t been available since 2005 due to a manufacturer’s decision to stop selling it as a prescription product.
“Today's FDA decisions follows nearly 50 years of data and research showing that progestin-only pills, such as Opill, are safe and effective,” said Frederique Welgryn, Perrigo’s global vice president for women's health, on a call with reporters.
FDA advisers in May unanimously supported making Opill available over the counter, citing the need for better access to contraception in the U.S. Perrigo presented data showing that consumers could adequately follow instructions for the drug’s use, as well as study results showing its safety and effectiveness.
“The risks to women of an unintended pregnancy are much greater than any of the things we were discussing as risks of putting this pill out over the counter,” said Katalin Roth, a professor at George Washington University’s medical school, at the May meeting.
Panelists did express some concerns over Opill’s use by adolescents and by women with certain medical histories like breast cancer, but felt the benefit of the drug being more widely available outweighed any risks.
In a memo on the decision, FDA official Karen Minerve Murry noted that, while there are many effective contraceptive options, many women face hurdles in obtaining a prescription, such as lack of health insurance, transportation difficulties or social stigma. Half of all pregnancies in the U.S. are unintended, according to the memo.
Women’s options once a pregnancy occurs have recently become more limited in some parts of the country. Following the Supreme Court’s recent reversal of Roe v. Wade, more states are now enforcing bans on abortion. The availability of mifepristone, a drug used for medical abortions, is also in doubt following a Texas judge’s invalidation of its FDA approval, although the Supreme Court ordered it to remain available while a circuit court hears the case.
Perrigo did not disclose the price it intends to charge for Opill, but said in an email that the drug’s cost will announced in coming months, before it’s available in stores.
The FDA’s decision applies only to Opill. All other brands and forms of oral birth control continue to require a prescription.