The French subsidiary of the pharmaceutical group, HRA Pharma, has filed a dossier with the American Medicines Agency (FDA) for Opill, a pill to be taken every day based on a synthetic progestogen, without estrogen, available on prescription since 1973, details a press release.
This request comes a few weeks after the decision of the Supreme Court to revoke the right to abortion in the country, on June 24th. But the company says it’s just a
coincidence pointing out that she has been working on the file for seven years.
” Landmark Procedure Marks a Turning Point for Contraceptive Access and Reproductive Equity in the United States »
If the green light is granted by the authorities, this
will help even more women and people access contraception without facing unnecessary barrierscommented Frédérique Welgryn, director of strategic operations and innovation at HRA Pharma, can we read in a press release.
Contraceptive pills are already on sale in many countries, including Brazil, Mexico, Portugal or Turkey. Other countries prefer to require a visit to a health professional, in particular to avoid possible contraindications and to discuss the risks for blood pressure.
Several major US medical organizations, including the Council of Obstetricians and Gynecologists (ACOG), have already expressed support for over-the-counter pills.
Data confirm that progestogen-only hormonal methods are generally safe and pose no or minimal risk of venous thromboembolismalso known as blood clots, says ACOG in a post on its site.
Several studies have demonstrated that women are able to use self-screening tools to determine their eligibility to use hormonal contraceptivesadds the organization.
For its part, the FDA declined to comment.