Pending Decision On First US OTC Birth Control Shines Spotlight On Self-Report Study Data
Approval likely would account for all weight on scale of FDA decision if not for self-report element in design of HRA Pharma’s actual use study for OTC switch of 0.075-mg norgestrel branded Opill. HRA’s sNDA offers lesson for using electronic diary apps in self-report studies.
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First OTC Oral Contraceptive Has Advisory Panel’s Unanimous Support Despite FDA’s Data Concerns
FDA officials again made clear concerns about “improbable dosing” data in HRA’s sNDA for 0.075-mg norgestrel tablet branded Opill before advisory panel voted at close of a two-day meeting conducted 60 years after first Rx oral contraceptive approved in US.
Cloud Over FDA Advisory Panel Meeting From ‘Over-Reporting’ In Birth Control OTC Switch Study
While HRA consultant says its study “meets or exceeds standards of most other studies assessing adherence, including an oral contraceptives,” FDA ONPD director says particpants’ over-reporting “is not something we see in a typical actual use study.”
US FDA Requests More Information, Needs More Time To Review Birth Control OTC Switch Proposal
FDA decision on Perrigo subsidiary’s proposal for first US OTC daily oral contraceptive is extended 90 days with the postponement of an advisory panel meeting. Agency requested additional information related to OTC switch application of 0.075-mg norgestrel initially submitted in July.