A US pharmaceutical firm asks permission to sell birth control pills over the counter.
o Paris-based HRA Pharma, has asked to be allowed to sell birth control pills over the counter.
o The pills, a most common mode of contraception have long required a prescription in the US.\
Pharma company seeks permission to sell over the counter contraceptive pills
For the first time in the US, a pharmaceutical firm, Paris-based HRA Pharma, has asked to be allowed to sell birth control pills over the counter. The firm says that its application to the Food and Drug Administration is unrelated. The pills, the most common form of contraception in the US, have long required a prescription and the announcement comes weeks after the Supreme Court overturned the constitutional right to abortion.
Studies have shown that over 50% of a closely estimated 6.1 million pregnancies in the US each year are unintended. While birth control pills were initially approved for use in the US about 60 years ago, about one-third of US women have reported difficulties in getting prescriptions for the same.
Globally, more than 100 countries provide oral contraceptives without a prescription. Several major US medication organizations such as the American Medical Association and American Academy of Family Physicians, have called on US authorities to do the same.
Frédérique Welgryn, Chief Strategic Operations and Innovation Officer at HRA Pharma, argued that the firm’s application is a “ground-breaking moment” in the fight for reproductive rights in the US. The application, the company has said, follows years of research intended to help make its case to US regulators.
According to the company, a decision from the FDA is to be expected next year and thereby approval would apply exclusively to the firm’s Opill drug, an acquisition from Pfizer in 2014.
Tensions surrounding reproductive rights in the US
The HRA’s application comes amid public debate over reproductive rights in the US, with Democratic lawmakers and pro-choice activists urging the FDA to consider similar requests while Conservatives have encouraged the ban on abortion rights.
Since the Supreme Court’s abortion ruling, leading US retailers have reported started rationing birth control pills amid surging demands. On Monday, US President Joe Biden’s administration directed healthcare providers to offer abortion services if the life of a mother is at risk.
The Department of Health and Human Services have said that physicians must provide abortions if they believe that a “pregnant patient” is experiencing an emergency medical condition and if the procedure would serve as a “stabilising treatment”. Emergencies include ectopic pregnancy, complications of pregnancy loss, or emergent hypertensive disorders, such as preeclampsia with severe features.
