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Pending Decision On First US OTC Birth Control Shines Spotlight On Self-Report Study Data

Executive Summary

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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After ‘Most Difficult Part’ Of Opill Decision, FDA Expects Pre-Study Tests Of Self-Reporting Methods

“Improbable results” in HRA’s actual use study data provide lesson for FDA and sponsors of future OTC switch applications on designing actual use studies, according to summary of agency’s review of HRA’s sNDA for the first US OTC oral contraceptive.

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.”

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