FDA Considers Application for Over-the-Counter Birth Control Pill
WASHINGTON (NEWSnet/AP) — U.S. health regulators are reviewing a request to make an existing birth control pill available without a prescription in this country.
Advisers to the Food and Drug Administration will hold a two-day public meeting next week as part of drugmaker Perrigo's application to sell Opill over the counter. Such a meeting is usually one of the last steps before an FDA decision; but the panel vote is not binding.
The FDA is expected to make its decision this summer.
Opill was first approved in the U.S. about 30 years ago. It is not currently marketed in the U.S., but is sold without a prescription in the U.K. Birth control pills also are available without a prescription in much of South America, Asia and Africa.
Non-prescription medicines are usually cheaper to purchase, but generally not covered by health insurance plans.
In its initial review, the FDA raised raised questions about whether women with certain medical conditions would correctly opt out of taking it. It noted signs that study participants had trouble understanding the labeling instructions. The agency also will ask whether younger teenagers will be able to understand and follow the instructions.
Hormone-based pills are the most common form of birth control in the U.S.; many of them are containing both progestin and estrogen.
Opill is a progestin-only formulation; which can result in reduced effectiveness unless it is taken at the same time each day.
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