FDA Scientific Pharmacoepidemiologic Research Program

The Food and Drug Administration established this Master IDIQ on September 18, 2014, to support pharmacoepidemiologic research using US population-based healthcare data for drug safety studies. The vehicle's ordering period closed on September 27, 2019, and is no longer available for new task orders.

This IDIQ is effectively inactive for pursuit. The most recent task order was awarded in September 2017, nearly nine years ago. Ordering authority expired more than six years ago. All three task orders under the vehicle have reached completion or are long past their ultimate completion dates, with the latest work concluding in May 2021.

The vehicle sustained minimal activity during its operational window. Only three task orders were issued across the entire three-year ordering window, averaging one per year. The FDA was the sole customer, ordering all work in support of pharmacoepidemiologic surveillance and medication safety assessment. Work focused on specific drug-safety studies: opioid exposure during pregnancy and related neural-tube defects, medication exposure during pregnancy more broadly, and the maintenance of the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP), which appears to be an ongoing FDA surveillance platform leveraging healthcare claims data.

Harvard Pilgrim Health Care, Inc., captured two of three orders worth $5.4 million combined potential value. Brigham and Women's Hospital Inc. held the single remaining order valued at $3 million. The market showed no competitive breadth; only two prime contractors ever competed or were selected under the vehicle.

Combined task-order potential value totaled $8.4 million, with $8 million obligated, representing 96% utilization. All task orders carried firm fixed-price pricing and no set-aside designations. Task-order ceiling values ranged from approximately $1.6 million to $3.8 million, with completion dates between 2019 and 2021.

This vehicle presents no forward opportunity for new business development.

The purpose of the FDA Scientific Pharmacoepidemiologic Research Program is to establish collaborations that would provide access to a range of different types of US population-based data resources to conduct timely studies as drug safety issues of heightened interest arise. Such collaborations would allow FDA scientists the ability to leverage existing healthcare data for pharmacoepidemiology studies that may be enhanced by application of pharmacogenetic, social science, and/or pharmacologic methods to contribute to evidence-based assessments of risk management tools, special populations, and even causes of medication errors to advance the FDA regulatory science mission.