First over-the-counter birth control pill in the US will be produced in Ireland

Opill, made by Irish-based Perrigo, will become the first contraceptive pill to win approval from the US Food and Drug Administration to be sold in the US without a prescription. File picture

An Irish-based company is behind the first-ever birth control pill to be sold over the counter without a prescription in the United States.

Perrigo Company plc, whose headquarters are in Dublin, will be part of manufacturing the tablet which is now set to transform reproductive care in America.

Perrigo's product, Opill, has been approved by the US Food and Drug Administration (FDA) and is expected to be available over the counter and in stores next year.

The decision comes as US president Joe Biden issued an executive order to improve access to affordable over-the-counter contraception.

Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research said: 

When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.

In a statement, Perrigo Company Plc said it had “achieved a major milestone in its ambition to provide women and people greater access to contraception".

The pill will be made in Ireland, Germany, and the US. 

In a statement to the Irish Examiner a spokesperson for Perrigo said the company was “more than eight years preparing the research to submit an application to the FDA and decades of advocacy, research and grassroots work by the reproductive health, rights and justice community”.

Perrigo Company plc's international headquarters are in Hogan Place in Dublin 2. It has been based in Ireland since 2013.

The company has not applied to have the drug sold in Ireland without a prescription.

A spokesperson for Ireland's Health Products Regulatory Authority (HPRA) said: “To date, the HPRA has not received an application from a pharmaceutical company to reclassify an oral contraceptive medicine to permit sale and supply without a prescription."