Following it’s $2 billion takeover by Ireland-headquartered Perrigo, HRA Pharma has now become the first drugmaker in the US to seek approval for an over-the-counter contraceptive pill.
The move comes as access to birth control becomes a pivotal issue following the landmark ruling by the Supreme Court last month to strip US women of their constitutional protection for the right to abortion.
HRA Pharma has filed for a prescription to OTC switch for Opill, a decades-old daily progestin-only pill.
The company’s chief strategic operations and innovation officer – Frédérique Welgryn – said that the application “marks a ground-breaking moment in contraceptive access and reproductive equity in the US”, where there are around three million unintended pregnancies every year.
Access to birth control is more important than ever after Roe v Wade was struck down, amid reports that anti-abortion campaigners in the US are now turning their attention elsewhere.
HRA Pharma is anticipating that the FDA will hold an advisory committee meeting to discuss the Opill switch and thinks it may be able to get approval in the first half of next year if all goes to plan.
It also comes as President Joe Biden has moved to expand access to birth control in the wake of Roe v Wade, signing an executive order that asks the Department of Health and Human Services (HHS) to expand access to reproductive health services including intrauterine devices, birth control pills, and emergency contraception.
HRA Pharma says that nearly a third of adult women in the US who have tried to obtain a prescription for birth control or a refill have reported difficulties doing so.