Economic Studies of FDA Regulations

The Economic Studies of FDA Regulations Indefinite Delivery/Indefinite Quantity (IDIQ) contract, awarded by the Food and Drug Administration's (FDA) Office of Planning, is designed to provide comprehensive economic assessments and analytical support for FDA regulatory actions. The contract vehicle enables the agency to obtain specialized research and economic analyses that require rapid data gathering, technical expertise, and the ability to conduct in-depth studies on complex regulatory topics. These economic studies are critically important, as they must withstand rigorous scientific and technical review from diverse stakeholders including government agencies, Congress, professional economists, and the scientific community.

Task orders under this IDIQ consistently focus on detailed economic characterizations, data analysis, and literature reviews across various FDA-regulated industries and programs. Eastern Research Group Inc. (ERG) has been the predominant prime contractor, winning multiple task orders with values ranging from approximately $107,000 to $509,000, typically with performance periods between one to four years. Research Triangle Institute (RTI) International has also been awarded task orders, though less frequently. The task orders cover a wide range of specific research areas, including economic studies of biologics industries, dietary supplements, tobacco product manufacturing, traceability compliance, breakthrough therapy designation program metrics, and health equity research. All task orders to date have been awarded without small business set-aside designations, and performance locations have primarily been in Maryland, Massachusetts, and other locations supporting federal agency needs.