Abstract
In 2022, HRA Pharma announced that it had submitted a long‐awaited application with the Food and Drug Administration (FDA) to switch Opill to over‐the‐counter (OTC) status. This was the first time that a drug company had filed such an application. Efforts to “free the pill” from the prescription began almost thirty years earlier. In 1993, the FDA proposed holding an open public meeting to discuss making the pill available over‐the‐counter. But pharmaceutical companies were reluctant to take on the challenge to make an oral contraceptive available OTC. The challenge was assumed by the Oral Contraceptives Over‐the‐Counter Working Group, founded in 2004, now called the Free the Pill coalition. Their goal was to make an OTC oral contraceptive that was affordable and accessible. This article explores their nineteen‐year‐long effort that has grown into a movement. The recent overturning of Roe v. Wade has added a sense of increasing urgency to their effort to bring an OTC oral contraceptive to market.
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