The Office of Surveillance and Epidemiology and other offices in FDA evaluate drug and biologics risks and then promote their safe use. To further this effort, FDA on December 20, 2013 posted a notice looking for sources that have capabilities in this specific marketplace.
The contractor will need to provide access to longitudinal patient-level electronic medical record data to enable FDA reviewers to evaluate drug-related safety issues of high regulatory priority in a timely manner.
FDA currently has several tools available to address postmarketing safety issues. These include a spontaneous reporting system for adverse events related to drug and biologics therapy, several complementary product utilization databases, and a scientific program to support epidemiologic investigations that provides indirect access to U.S claims-based health encounter data for pharmacoepidemiology studies.
To strengthen and complement these resources, FDA is looking to acquire direct access to de-identified EMR data. FDA is not interested in developing this database but expects to use a qualified organization to provide:
- Direct unlimited access to an existing commercially available, longitudinal population-based de-identified EMR data
- EMR data covering a minimum of ten million research qualified patients and five million active patients
- Data in real-time access
- Large datasets as needed
- Linkage to de-identified hospital episode data, national death index data, and mother–baby linkages
- Information validating clinical events or other medical information
- Technical and clinical support on drug safety research to assist in using the data resource for epidemiologic studies
- Training and written documentation to support using the data resource for epidemiologic studies
For more information, go to www.fbo.gov for the Sources Sought Notice (Electronic Medical
Record Data) (Solicitation Number FDA-SS-1127349). The due date to FDA is January 07, 2014. The primary point of contact is James Chestnut, at james.chestnut@fda.hhs.gov.