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Switch Credentials
At the forefront of Rx-to-OTC switch, Steve Neumann has served as a key player in strategy and regulatory development plans
Experience with switch assessment in existing and prospective categories Seasoned lead on consumer behavior studies with two Non-Prescription Drug Advisory Committee (NDAC) presentations leading to switch approvals Presentation of development plans at numerous FDA meetings. Proven track record of working collaboratively with FDA to shape approach, including accelerated timelines Presenter at numerous Industry (CHPA)/FDA round tables on switch study protocols and consumer research methods Experience with design and execution of consumer research studies to support device approvals Critical knowledge from several aborted or unsuccessful programs |
Some Notable Accomplishments
Pioneered clinical protocol methods with market research companies unfamiliar with GCP standards prior to FDA label study guidance. Conducted early study regarded by FDA Consumer Behavior Scientist at the time as “the best study of its kind”
Incorporated on-line consumer and physician survey data in a switch submission to explain that behaviors of concern already existed in the marketplace and that safety fears were unfounded. One of the first uses of internet generated survey results in a switch submission.
Innovative study design and execution including one of the early uses of “telemedicine” to support a switch program
Conducted one of the first label discernment studies to support Phase 4 marketing commitment regarding consumer understanding of ingredient differentiation. Approach has become a tool for DMEPA in support of umbrella branding
Incorporated on-line consumer and physician survey data in a switch submission to explain that behaviors of concern already existed in the marketplace and that safety fears were unfounded. One of the first uses of internet generated survey results in a switch submission.
Innovative study design and execution including one of the early uses of “telemedicine” to support a switch program
Conducted one of the first label discernment studies to support Phase 4 marketing commitment regarding consumer understanding of ingredient differentiation. Approach has become a tool for DMEPA in support of umbrella branding