FDA Reorganization to Promote Drug Quality

After almost two years of anticipation, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), has administration approval for organizational changes to bolster programs and policies to ensure drug quality. The Department of Health and Human Services and the White House have finally signed off on her plan to establish a new CDER “super” Office of Pharmaceutical Quality (OPQ), a change originally proposed in the fall of 2012. The change aims to establish the “once voice for quality” that Woodcock has championed by providing “better alignment among all drug quality functions at CDER, including review, inspection, and research,” Woodcock explained in an internal staff memo.

A main change, which will go live Jan. 5, 2016, is to shift to OPQ the functions performed by CDER’s Office of Pharmaceutical Science (OPS), which oversees the chemistry, manufacturing, and controls (CMC) submissions for drugs and biologics and conducts research on drug formulation and manufacturing issues. The new office also will house surveillance functions related to preapproval and surveillance inspections now carried out by CDER’s Office of Compliance, with an eye to achieving uniform quality oversight for new drugs, generic drugs, and over-the-counter products.

Woodcock will head OPQ on an acting basis, assisted by deputy director Lawrence Yu, who has been serving as acting director of OPS for the past year. Steve Kozlowski will continue as director of the Office of Biotechnology Products, and Cindy Buhse remains acting director of the Office of Testing and Research. The Office of New Drug Products (acting director Sarah Pope Miksinski) and Office of Lifecycle Drug Products (acting director Susan Rosencrance) will process CMC applications for new drugs and for generic drugs. A new Office of Surveillance will develop written standards and inspectional procedures; it is headed on an acting basis by Theresa Mullin, currently director of CDER’s Office of Strategic Programs where she has headed up efforts to develop quality metrics for assessing quality manufacturing operations and products.

Other new operations include an Office of Program and Regulatory Operations, an Office of Policy for Pharmaceutical Quality, and an Office of Process and Facilities.

Additional changes will take place in other CDER operations. The Office of Compliance (OC) will focus on compliance and enforcement activities designed to detect unsafe, ineffective, and poor quality drugs. In addition, OC’s Office of Scientific Investigations will shift responsibility for inspections of bioequivalence/bioavailability studies and non-clinical studies to CDER’s Office of Translational Sciences (OTS). OTS also will expand its capabilities to evaluate bioequivalence studies for new and generic drugs and will add a division to provide statistical services to the Office of Generic Drugs.

The new OPQ will provide a single drug quality assessment “that captures the overall OPQ recommendation on approvability,” Woodcock said in her message. Manufacturers will gain feedback on quality deficiencies earlier in the review cycle, and FDA will be able to provide a more uniform quality program across domestic and foreign manufacturing sites, and across all drug product areas. The result will be “consistent approaches, a transparent process, and clear standards to which the regulated industry must conform,” she commented.

Woodcock has voiced these goals repeatedly in the past two years, emphasizing the need to instill a “culture of quality”-not a culture of compliance-throughout the biopharmaceutical industry. She explained at the PDA/FDA Joint Regulatory Conference in September that establishing a team-based CMC review process, with inspectors on those teams, aims to promote quality production and end wasteful processes. She anticipates “rapid evolution” of these initiatives over the next few years.

More information on the CDER reorganization is available on FDA’s website.