A group of external advisers to the FDA voted in favor of an application from a pharmaceutical company to put their prescription birth control OTC.
When Caitlyn Pace moved from the United States to Hong Kong three years ago to take a teaching job, she loved the food, the sights and the birth control.
She was pleasantly surprised to find that in Hong Kong, she could get oral contraceptives at her neighborhood drugstore without a prescription.
« My jaw probably dropped the first time I did it. I just walked in and kind of looked around and was like ‘is this really happening?’ » said Pace, 34. « It’s like buying aspirin. »
For years, medical organizations have fought to have over-the-counter birth control pills in the US, too.
On Tuesday and Wednesday, a group of external advisers to the US Food and Drug Administration will discuss an application from a pharmaceutical company to put their prescription birth control pill over the counter.
Although professional organizations including the American Medical Association and the American College of Obstetricians and Gynecologists support over-the-counter sales of the drug, called Opill, the FDA seems skeptical, citing a list of concerns in a 130-page document posted online Friday.
« I am worried » about the FDA’s decision, said Dr. Kristyn Brandi, a spokesperson for the American College of Obstetricians and Gynecologists.
But, nevertheless, on Wednesday, the advisors voted in favor of allowing the pill to be sold over the counter.
Concerns about weight, following the label
The FDA scientists say they have two main concerns about Opill, a « mini-pill » that uses only the hormone progestin.
One has to do with obesity. The FDA approved Opill as a prescription drug in 1973, and « the prevalence of obesity in adults in the United States has changed dramatically since the original clinical studies were conducted over 50 years ago, » the scientists wrote in the document, citing a 13% obesity rate in 1960 compared with a 42% obesity rate now.
