The potential to mine electronic medical records (EMRs) for insights into disease prevalence, drug adherence, patient safety and a host of other areas has attracted a who's who of Big Pharma, with the likes of GlaxoSmithKline ($GSK), Johnson & Johnson ($JNJ) and Pfizer ($PFE) all running programs. And now the FDA is pushing ahead with its plans by seeking access to a patient-level database.
The FDA began the process when it posted a brief outline of its database requirements late last year. The latest document goes further, giving a detailed description of what the FDA wants from the database and calling for companies able to deliver such capabilities to submit proposals. The FDA wants the database to give it a complete picture of patients' interactions with all aspects of the healthcare system, with priority being given to contractors that have taken steps to link EMR data from across the fragmented landscape of physician practices, hospitals and other medical institutions.
By accessing such a resource, the FDA hopes to bolster its postmarket surveillance capabilities, an area the agency was tasked with improving under the 2012 PDUFA renewal. The FDA already has access to claims data, but direct access to a cloud-based trove of longitudinal, de-identified patient-level information will provide more detail. The agency wants the database to contain details of at least 10 million research qualified patients, five million of whom must be active. Age, gender, medical condition, coexisting disease, drug dose, duration of prescription and concomitant medications will all be recorded.
Having access to all this information will allow the FDA to estimate the contribution of different risk factors. As postmarket surveillance is the goal, the FDA is calling for contractors to provide particularly detailed accounts of medications. As well requiring the name, strength and dosage form of each drug, the FDA wants to know the specialty of the prescriber, what instructions were given to the patient and several other variables. By linking this data to other health records--and external databases like the National Death Index and cancer registries--the FDA hopes to better assess drug safety.
- read the FDA request