WASHINGTON (AP) – United States (US) health regulators are weighing the first-ever request to make a birth control pill available without a prescription.
But in an initial review posted on Friday, the Food and Drug Administration (FDA) raised concerns about drugmaker Perrigo’s application to sell its decades-old pill over the counter.
The FDA cited problems with the reliability of some of the company’s data on the drug, Opill, and questioned whether women with certain other medical conditions would correctly opt out of taking it. The agency also noted signs that study participants had trouble understanding the labelling instructions.
