The FDA’s Center for Drug Evaluation and Research (CDER) said today it will step up its oversight of drug quality next year through a new “super-office” created for the purpose, with functions and personnel that will be shifted there from existing offices.
CDER’s new Office of Pharmaceutical Quality (OPQ) will be the center’s single unit dedicated to the purpose, and will begin operations on Jan. 5, 2015. OPQ will consist of an immediate office and subordinate offices, all reporting directly to CDER Director Janet Woodcock, M.D.
OPQ will also include activities now carried out through three existing CDER offices:
- The Office of Pharmaceutical Science (OPS), whose functions and staff will move to OPQ. Until now, OPS has been “an umbrella organization over the activities of chemistry manufacturing and controls (CMC) review,” according to its web page.
- The Office of Compliance (OC), whose preapproval and surveillance inspection activities will also move to OPQ. OC “will focus on compliance and enforcement operations and policy to minimize consumer exposure to unsafe, ineffective, and poor-quality drugs,” Dr. Woodcock said.
- The Office of Translational Sciences (OTS), which will handle inspection-related activities for bioequivalence/bioavailability and nonclinical studies, now the responsibility of OC’s Office of Scientific Investigations.
In a message to CDER staff, Dr. Woodcock said OPQ would improve the center’s oversight of quality throughout the lifecycle of a drug product by creating a uniform drug quality program across all sites of manufacture, domestic or international, and across all drug product areas—new drugs, generic drugs, and over-the-counter drugs.
“OPQ will provide feedback on quality deficiencies earlier in the review cycle,” Dr. Woodcock said. “OPQ’s structure provides for centralized functions for administrative activities, project management, training, quality management systems, and policy.”
OTS will see two of its existing review divisions—the Division of New Drug Bioequivalence Evaluation and the Division of Generic Bioequivalence Evaluation—housed within a newly established Office of Study Integrity and Surveillance.
CDER’s Office of Biostatistics will see the establishment of a new Division of Biometrics VIII, designed to support delivery of comprehensive statistical services to the Office of Generic Drugs.
“The restructuring will improve the way we deal with global challenges and increasing product complexity, and assure that quality medicines are available to the American public,” Dr. Woodcock added.