FDA Scientific Pharmacoepidemiologic Research Program

The FDA Scientific Pharmacoepidemiologic Research Program Master IDIQ is a federal contract vehicle designed to establish collaborative research capabilities for conducting comprehensive drug safety studies using population-based healthcare data resources. The primary objective is to support the Food and Drug Administration's regulatory science mission by enabling timely pharmacoepidemiologic investigations that leverage existing healthcare databases. Through this vehicle, researchers can apply advanced methodological approaches including pharmacogenetic, social science, and pharmacologic techniques to assess medication risks, evaluate risk management tools, and investigate special population health outcomes.

Task orders under this IDIQ have focused on specific medical research studies, particularly those examining drug safety during pregnancy and maternal health contexts. Notable task orders include a $2.96 million contract awarded to Brigham & Women's Hospital to develop Medicaid data capabilities for post-market drug safety surveillance during pregnancy, and another $3.78 million contract investigating neural tube defect risks among live births exposed to maternal opioid prescriptions. The task orders are consistently awarded as firm fixed-price delivery orders, with values ranging from approximately $1.3 million to $3.8 million and completion periods of 2-3 years. No specific set-aside designations were used in the awarded task orders, and the primary funding agency is the Department of Health and Human Services Food and Drug Administration, with research institutions like Brigham & Women's Hospital emerging as key prime contractors.