The FDA Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive & Urologic Drugs Advisory Committee last week voted unanimously that the benefits of making daily oral contraceptive Opill (norgestrel 0.075mg) available for OTC use outweigh the risks. Perrigo affiliate, French-based HRA Pharma, filed an application in July 2022 for OTC use of the progestin-only drug. While not binding, the panel’s vote will be considered by the FDA when making its final decision regarding the potential approval of Opill for OTC use, which is expected later this year.
If approved, Opill would be the first daily birth control pill available OTC in USA. Perrigo President & CEO Murray Kessler said during a Q2 2022 earnings call – at the time the switch application was filed – that he expected the FDA evaluation would take 10 months. Opill is “in the process of being filed in at least three more countries in Europe”, although “they’re not on as fast a track”, he said at the time.
Comment from Regional VP, North America, Liz Cummings: HRA’s application for the Rx-to-OTC switch of Opill featured a model showing that if 100,000 women were to continue to use existing birth control methods with high failure rates, there would be 37,624 unintended pregnancies. However, if all of them used OTC progestin-only pills with a failure rate of 7%, this would fall to 7,000. Citing this study while representing HRA, physician Professor Anna Glasier noted that OTC availability showed an 81% reduction of pregnancies in the rhetorical cohort of women and would serve an unmet need for many. She added: “Birth control is a great milestone in the history of medicine. It is extremely safe and HRA demonstrated that it does work … let’s make a little more history today and approve the pill as an OTC.”
During the hearing, HRA presented evidence showing that Opill has a strong safety profile, supported by OC Rx availability for 63 years and consumers (including adolescents) were able to appropriately self-select and use it. Actual use by study participants was measured by self-recording adherence to daily use and time of ingestion, with results showing rates within the scope of normal Rx adherence. However, the FDA felt that HRA’s studies did not comply with its switch guidance and the agency’s analysis showed less confidence in the accuracy in self-selection and daily adherence. Deputy Director of the FDA’s Office of Nonprescription Drugs, Dr Karen Minerve Murry, noted that the FDA was presented with many challenges by the actual use studies submitted, but emphasised that it knows the importance of OTC access. The FDA’s disagreements with HRA study results means it may be some time before final approval, but given the public health benefit, we could have a positive result by end-2023.
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