The FDA reorganizes to “combine non-enforcement-related drug quality work into one super-office [OPQ], creating one quality voice and improving our oversight of quality throughout the lifecycle of a drug product.”
The FDA’s new OPQ has opened, beginning its assumption of certain drug quality oversight functions from the Office of Pharmaceutical Science, Office of Compliance and Office of Translational Sciences in order to provide centralized quality supervision throughout the product life cycle. The FDA has clarified that the decision to reorganize was not motivated by an increase in quality issues but rather by the goal to prevent or mitigate quality issues so they do not lead to drug shortages that affect patients. Its vision is that the OPQ “will be a global benchmark for regulation of pharmaceutical quality” and establish standards for Industry, including clinical quality attributes and clinically relevant specifications that facilitate patient access to quality medications.
It is anticipated that the OPQ will maintain master data repositories and provide information from its surveillance to assist the Office of Regulatory Affairs in prioritizing and streamlining inspections. As acting director of the OPQ Lawrence Yu noted, “OPQ will work to balance regulatory resources between pre-marketing evaluation and post-marketing surveillance, and transform product quality oversight from a qualitative to a quantitative and expertise-based process.”