HRA Pharma asking FDA for permission to sell birth control pill Opill over the counter
NEW YORK -- A historic moment in women's health could be on the horizon.
As CBS2's Lisa Rozner reported Monday, a pharmaceutical company is asking the Food and Drug Administration for permission to sell a birth control pill over the counter in the U.S.
Since receiving approval in 1973, Opill has been available with a prescription for women to take to prevent pregnancy.
Now the company that makes it, HRA Pharma, is asking the FDA to let the pill be available for all women over the counter.
It's a change groups such as the National Organization for Women have been pushing for decades.
"Against the backdrop of a federal ban on protection, for abortion, it is time for electeds to step and do everything they can for women. There can be absolutely no excuses now," said Sonia Ossorio, president of NOW New York State.
Peter Pitts is a former associate FDA commissioner who served when President George W. Bush was in office. He says the committee will take public health into account, but the focus will be on science and data.
"Is the product safe enough to be chosen and taken without any interaction from a physician? The second, is the drug safe enough not to have any untoward side effects? And is the way you take the drug, are the instructions clear enough?" Pitts said.
Pitts was on the FDA when the "morning after" pill was approved to go from being a prescription drug to over the counter. He says the review could take around one year.
The French drug maker's application compiles years of research intended to convince the FDA that women can safely screen themselves for those risks and use the pill effectively.
"Nearly 30 percent of women have trouble accessing birth control for a wide variety of reasons," Ossorio said.
"When product moves from RX to OTC, insurance doesn't cover it. Policymakers will need to consider that," Pitts said.
It is available over the counter in other countries such as South Africa and in the United Kingdom.
Another company said it is putting a package together and at some point in the future may make a similar request.
