FDA approves first over-the-counter birth control pill in US
July 13 (Reuters) – The U.S. Food and Drug Administration on Thursday approved the first over-the-counter contraceptive pill, paving the way for millions of women to purchase birth control without prescription in the country.
The daily contraceptive Opill, sold by Perrigo (PRGO.N), was first approved for prescription use in 1973, and the over-the-counter approval clears the way for people to obtain it without first seeing a healthcare provider.
The pill will be available in stores and online in the first quarter of next year, Perrigo said adding that it will share information on pricing and distribution plans in advance.
The approval is expected to cut barriers of access to contraceptives such as the cost and time of seeing a healthcare provider, advocacy groups have said.
“Today, we made history. This decision will mean people across the US will have a new and easier way to access oral contraceptives,” said Kelly Blanchard, President of Ibis Reproductive Health, a non-profit research firm.
Studies have shown that a big proportion of consumers can understand the label instructions for using the drug, supporting their ability to properly use it, the FDA said.
The FDA’s decision comes after a panel of advisers in May voted unanimously in favor of allowing the sale of the drug without a prescription.
The approval comes at a time of increased focus on birth control since the U.S. Supreme Court last year overturned the constitutional right to terminate pregnancies by scrapping a landmark ruling in the 1973 Roe vs. Wade case.
Perrigo gained the daily-use pill first through its $2.13 billion acquisition of Paris-based HRA Pharma in 2021.
Shares of the company rose 5% in early trading.