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HRA Pharma expects the regulator to hold an advisory committee meeting and approve the application in the first half of 2023, which is typical for such requests, said Frédérique Welgryn, HRA Pharma’s chief strategic operations and innovation officer.
“The timing is a bit coincidental. We have been working on that application for the last seven years,” Welgryn said, adding the firm had been conducting consumer research and clinical trials, among other processes, before filing the application for the switch to OTC from prescription.
The contraceptive is currently a prescription drug sold under the brand Opill.
The FDA did not immediately respond to a Reuters request for comment.
The non-estrogen pill has been used with prescription since it was FDA-approved in 1973. Perrigo said scientific evidence has shown progestin-only pills like Opill are effective at preventing pregnancy and safe for most women to use.
The conservative-leaning U.S. Supreme Court’s decision last month curbing the right to an abortion has shifted the focus to contraception and medical abortion.
Abortion rights activists have stepped up calls to make mifepristone, which in combination with a second drug called misoprostol induces an abortion up to 10 weeks into a pregnancy, available OTC.
Currently, the only contraception drugs available for women without a prescription are emergency oral pills that can be taken within three days after having unprotected sex.
