A: THE INTENT OF THE COLLECTION OF INDUSTRY METRICS IS IN THE RIGHT DIRECTION. To date, the information the FDA gathers is limited to compliance data, which provides only a snapshot of the compliance level of a site and some indication of quality based on a limited set of surrogate measures. Having a collection of specific quality metrics can bridge the gap between snapshots and a more real-time depiction of the quality at a site. We will have greater clarity regarding what information will be used in determining potential inspection frequency and focus. Conversely, the FDA will have a more expansive data set to make well-supported, risk-based determinations, and subsequently allocate resources to sites of greatest risk to the patient. However, part of the “right direction” will require addressing the diversity of the industry and product landscape while still providing an effectiveness measurement of the metrics program itself.
JASON URBAN, PH.D.
Jason is the senior director of global quality operations for Celgene Corporation.