FDA to combine all of its quality ops under a new ‘super’ office
Originally announced in 2012 in response to a growing focus on generic drug quality, the new office will combine all non-enforcement-related drug quality work to improve the agency’s oversight of quality.
The shift to one “super” office will require a number of changes. Among the expected realignments include:
- Moving functions and personnel from the Office of Pharmaceutical Science, which oversees the chemistry, manufacturing, and controls (CMC) submissions for drugs and biologics, to OPQ;
- Shifting preapproval and surveillance inspection activities from the Office of Compliance to OPQ; and
- Transferring inspection-related activities for bioequivalence/bioavailability and non-clinical studies from OC’s Office of Scientific Investigations to the Office of Translational Sciences.
“OPQ creates a uniform drug quality program across all sites of manufacture, whether domestic or foreign, and across all drug product areas,” the agency says on the new website.
Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), will lead the new office.
According to a memo obtained by RAPS last week, Woodcock said: “The organizational structure, along with new processes and policies, will support our mission to ensure that safe, effective, high quality drugs are available for the American public.”
Other new offices to be combined under OPQ include ones for Program and Regulatory Operations, Policy for Pharmaceutical Quality, and Process and Facilities.
"This office will provide internal customers with a single drug quality assessment that captures the overall OPQ recommendation on approvability, and OPQ will provide feedback on quality deficiencies earlier in the review cycle,” she added.
Other leaders that will join OPQ include:
- Office of Program and Regulatory Operations (OPRO): Giuseppe Randazzo (Acting);
- Office of Policy for Pharmaceutical Quality (OPPQ): Ashley Boam (Acting);
- Office of Biotechnology Products (OBP): Director: Steve Kozlowski;
- Office of New Drug Products (ONDP): Sarah Pope Miksinski (Acting);
- Office of Lifecycle Drug Products (OLDP): Susan Rosencrance (Acting);
- Office of Testing and Research (OTR): Lucinda (Cindy) Buhse (Acting);
- Office of Process and Facilities (OPF): Christine Moore (Acting); and
- Office of Surveillance (OS): Theresa Mullin (Acting).
The agency did not respond to a request for comment by press time.