Washington DC.- A Food and Drug Administration (FDA) advisory panel has said a decades-old birth control pill should be sold without a prescription, paving the way for likely US approval of the first over-the-counter birth control drug. .
If the FDA approves the drug, called Opill, for sale without a prescription this summer, it could significantly expand access to contraception, especially for young women and those who struggle to deal with the time, cost, or logistical hurdles involved in visit a doctor.
The FDA’s advisory panel voted unanimously in favor of drugmaker Perrigo’s request to sell its once-daily drug without a prescription.
The recommendation came at the end of a two-day meeting focused on the company’s research into whether women could safely and effectively take the pill without professional supervision. A final decision from the FDA is expected this summer.
However, approval is not a foregone conclusion. FDA scientists who analyzed data submitted by the pill’s maker, HRA Pharma, raised concerns about whether women with medical conditions that should prevent them from taking the pill (mainly breast cancer and undiagnosed vaginal bleeding) would avoid the product. .
Agency reviewers also questioned the reliability of data from a company study that was intended to show that consumers would follow label instructions to take the pill at around the same time each day and use another form of contraception or abstaining from sexual intercourse.
But the panel largely brushed aside those concerns, emphasizing the benefits of providing more effective birth control, particularly to young people and low-income groups, than what’s available over-the-counter now, such as condoms and diaphragms.
Outside experts said they were confident that women of all ages could use the drug appropriately without first consulting a health care provider.
“I think this is a viable option to support access and will support the prevention of unplanned and unwanted pregnancies,” said Jolie Haun, a researcher with the Department of Veterans Affairs, who voted in favor of the pill.
Over-the-counter drugs are usually cheaper, but are usually not covered by insurance. Requiring insurers to cover over-the-counter birth control would require a regulatory change by the federal government.
Birth control pills are available without a prescription in much of South America, Asia, and Africa.
