FDA advisory committee votes in favour of OTC contraceptive pill
Betsy Goodfellow | May 11, 2023 | News story | Medical Communications |Â Â Contraception, FDA, OTC, Perrigo, contraceptionÂ
Perrigo Company has announced that the US Food and Drug Administration’s (FDA) Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee (ORUDAC) have voted unanimously that making Opill, a progestin-only daily contraceptive pill, available for over-the-counter (OTC) use outweighs the risks.
This vote is not binding for the FDA, however it is likely that it will be considered when the final decision is made regarding Opill’s potential OTC use. This decision is expected later in 2023.
The drug is comprised of 0.075mg norgestrel, which has been used to prevent pregnancy in the US since its FDA approval in 1973.
The Opill OTC development programme has been taking place for the last eight years, and includes multiple Label Comprehension studies (LCS) which demonstrated that consumers could understand the OTC label, as well as an actual use trial, ACCESS, which proved that consumers could use Opill correctly, according to the label and follow the dosing instructions. Adherence in the ACCESS trial was also equivalent to in a prescription setting.
Murray S Kessler, president and CEO of Perrigo, commented: “Today’s vote to recommend a switch of Opill to OTC is a new, groundbreaking chapter in reproductive health. Perrigo is proud to lead the way in making contraception more accessible to women in the US. We are motivated by the millions of people who need easy access to safe and effective contraception. Today’s outcome reflects Perrigo’s steadfast commitment to women and people, and their health.”
Frederique Welgryn, Perrigo’s global vice president for women’s health, added: “Today’s vote reflects the strong data showing that Opill can be used safely and effectively OTC. FDA’s approval of Opill for OTC use would address a key unmet need for contraceptive access, be a groundbreaking expansion for women’s health nationwide and a step toward ensuring people can have improved access to contraception without unnecessary borders.”
Betsy Goodfellow
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