(New York) The Perrigo laboratory announced on Monday that it had asked the American authorities for the green light for what would be the first contraceptive pill available over the counter in the United States, a few weeks after the Supreme Court’s decision to revoke the right to abortion in the country.
It is a French subsidiary of the pharmaceutical group, HRA Pharma, which 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.
The launch of the regulatory process shortly after the Supreme Court’s decision to overturn, on June 24, the right to abortion in force throughout the United States, is “a coincidence”, assures the company, stressing that HRA was working on the case for seven years.
The FDA declined to comment.
“This historic procedure marks a turning point in access to contraceptives and for reproductive equity in the United States,” commented Frédérique Welgryn, director of strategic operations and innovation at HRA Pharma, in the press release.
If given the green light, it will “help even more women and people access contraception without facing unnecessary barriers,” she added.
Birth control pills are already available over the counter 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, however, already expressed support for over-the-counter pills.
“The data confirms that progestin-only hormonal methods are generally safe and pose no or minimal risk of venous thromboembolism,” also known as blood clots, ACOG said in a post on its site.
“Several studies have demonstrated that women are able to use self-screening tools to determine their eligibility for the use of hormonal contraceptives,” adds the organization.
