Survey analysis on comparative use human factors processes

Proposed generic drug-device combination products submitted for FDA approval through the Abbreviated New Drug Application (ANDA) pathway require a comparison to the specific brand name version of the drug, or reference listed drug (RLD). The application requires data demonstrating the generic drug is not only pharmaceutically equivalent, but also that any associated device administering the drug is interchangeable from a human factors perspective. In 2017, the FDA made available the draft guidance for industry entitled "Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA". This project surveyed key human factors stakeholders utilizing the guidance to identify the methods employed and potential gaps in the Comparative Use Human Factors (CUHF) process. Participants included human factors experts involved in preparing generic combination products for FDA approval. After completing a 10-question, IRB approved questionnaire participants were invited to participate in a 30 min virtual interview. The scripted interview probed for the participants' expertise, types of combination products supported, experience conducting CUHF studies, and perceived best practices/challenges of the CUHF process outlined in the draft guidance. A total of 14 participants completed the questionnaire with 9 participating in follow-up interviews. Interview transcripts were reviewed by 2 researchers and coded by topic for further analysis. Results indicate HF experts appreciate specific expectations outlining the threshold analysis and identifying the method as a systematic, well-defined process. Challenges reported from the guidance include frustration with objectives that vary compared to other FDA guidance's, a challenging process for calculating sample size, difficulty obtaining historical device data for a comparative assessment, a lack of methodology to compute and categorize errors, failure to address severity of errors, and confusion calculating acceptable error rates. Findings from the survey/interviews are being used to identify requirements for a proposed comparative human factors method.