Survey of Drug Importer Practices

Title VII of the Food and Drug Administration Safety and Innovation Act provided FDA with authority to ensure the safety, effectiveness, and quality of drug products imported into the United States. To promulgate new rules, FDA required a survey to establish baseline safety and quality control practices among importers of drug products. When FDA contracted with ERG to conduct this survey, we understood that FDA’s broad definition of drug product would pose a major challenge. Because the definition was so broad—for example, it included commonplace items like dandruff shampoo, toothpaste with fluoride, and anti-perspirant deodorants—many different types of businesses were being reported to FDA by import brokers and agents as having imported a drug product. The survey design would need to take this into account in order to avoid the potential for confusion. 

ERG designed, co-authored (with FDA), and administered an electronic survey to gather baseline data on current practices by drug importers to ensure the safety and quality of their imported animal and human drug products, to identify potential health risks or problems in the imported drug supply chain, and to better characterize what kinds of establishments are being reported to FDA as importing drug products. To inform survey design, ERG conducted cognitive interviews with several potential survey respondents and, based on those interviews, modified the survey and its instructions to clarify for respondents how and why they were considered importers of drug products into the United States. To further refine the survey design, ERG pretested the survey by sending it to approximately 100 respondent companies. The cognitive interviews and pretest enabled ERG to augment explanatory information and rewrite some survey items. As a result of these refinements, the response rate for the full-scale survey was nearly twice that obtained from the pretest of 100 respondents.