After the Paris-based pharmaceutical company submitted a drug application in mid-July, an FDA advisory committee was slated to meet Nov. 18. That date will be rescheduled “to review additional information requested related to the Opill Rx-to-OTC switch,” Dublin-based Perrigo, HRA Pharma’s parent company, said in an Oct. 26 statement. An exact date has not been determined.
If the contraceptive — which was approved in 1973 — is authorized for over-the-counter use, it would be the first birth control drug to be sold on pharmacy shelves.
Before the Supreme Court’s landmark decision to overturn Roe v. Wade, the American Medical Association urged the FDA to allow oral contraceptives to be sold over the counter.
“Expanding OTC access would make it easier for patients to properly use oral contraceptives, leading to fewer unplanned pregnancies,” the AMA said in a June 15 statement.
The FDA also delayed the potential approval of Opill by 90 days, Perrigo said, meaning once the advisory committee votes whether to recommend the decision, the regulatory agency has up to three months to make a final call.
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