FDA Access to Patient Drug Utilization Data

FDA's Center for Drug Evaluation and Research (CDER) awarded this Master IDIQ on September 22, 2014, for outpatient prescription and patient-level drug utilization data subscriptions; ordering closed on September 30, 2019, and the vehicle is no longer active. The shared ceiling across all awardees was $34.67 million.

The contract delivers real-time, multi-user desktop access to commercially available longitudinal prescription and claims data supporting epidemiological drug safety analysis. Scope includes national-level counts of outpatient prescriptions and unique patients by drug product over time; linked prescription-medical claims and patient-level records; patient-level exposure duration and concomitant drug-use analysis; nationally projected drug utilization patterns; direct unlimited Internet or network access to HIPAA-compliant data; and bulk download capability for large datasets. All data delivery occurs in a multi-user environment with real-time responsiveness.

The vehicle is closed to new orders as of 2019 and represents a historical contract family artifact. Any ongoing FDA drug utilization data needs would require pursuit under successor vehicles or new procurements; this IDIQ cannot support new task orders.

The Center for Drug Evaluation and Research (CDER) has awarded a Master IDIQ for outpatient prescription and patient level drug utilization data subscription to provide FDA personnel with real-time, immediate, direct, multi-user, desktop access to currently existing, commercially available, longitudinal data. These data will have the capability of providing current and historical national-level counts of outpatient prescriptions and unique patients utilizing prescription drug products in an outpatient setting over time; prescription-medical claims and patient-level information, in either the same or separate, linked resources; the ability to use these data to characterize the duration of exposure to prescription drug products at the patient level and to examine concomitant use of multiple drug products at the patient level over the same time period; the ability to use these data to describe national patterns of drug utilization in the outpatient setting through the use of projection or other appropriate methodologies that are scientifically sound and transparent to FDA personnel; direct, unlimited, Internet or network-based access to all HIPAA-compliant data in a multi-user environment and in real time; and the ability to download (or obtain in a timely manner using other means) large datasets as needed, for the purpose of conducting epidemiological drug safety studies.