“For a product that has been available for the last 50 years, that has been safely used by millions of women, we thought it was time to make it more accessible,” said the director of strategy at HRA Pharma.
For the first time a pharmaceutical company requested this Monday permission to sell a contraceptive pill without a prescription in the US, collects AP.
Despite the fact that in the North American country millions of women use hormone-based pills to control their fertility, these drugs always have required a prescription so that health professionals can detect conditions that increase the risk of blood clots in the body.
In this context, the application of the French company HRA Pharma is based on years of research and seeks to convince the US Food and Drug Administration (FDA, for that women can safely screen themselves for those risks and use the pill effectively.
“For a product that has been available for the last 50 years, which has been safely used by millions of women, we thought it was time to make it more accessible,” said Frederique Welgryn, chief strategy officer at HRA.
It is anticipated that FDA approval could take place as soon as next year and would only apply to the HRA pill, which would be sold under its original brand name, Opill.
However, a possible acceptance could set up a high-stakes decision for health regulators amid legal and political battles over reproductive health in the US
Lo Reproductive rights advocates want other prescription contraceptives to be sold without a prescription and, eventually, abortion pills to go the same way.
Late last year, the FDA was condemned by abortion opponents and praised by women’s rights advocates when it relaxed access to abortion pills.