Establishing a new Office of Product Quality in the Center for Drug Evaluation and Research (CDER) is a top priority for CDER director Janet Woodcock, and she plans to take charge of the operation personally when it is established next year. Her much-discussed reorganization effort is not just an exercise in moving around boxes, but aims to ensure the delivery of quality medications to patients, she explained at the Generic Pharmaceutical Association’s Fall Technical Conference in October.
Woodcock expects OPQ to become operational in 2014, and is moving forward with completion of a concept of operations for the new office, along with an organizational structure. But it is “not a done deal,” Woodcock observed at the ISPE annual meeting last month. She expects it will take at least six months for the new organization “to become real.”
One aim is to establish “one voice for how FDA regulations drug quality”––within CDER and in its relationships with other FDA of offices and other regulatory authorities. This will apply to new drugs, generics, over-the-counter products––biotech therapies and small molecules alike.
OPQ will form specialized staffs for product review and for inspections, with specific units to handle active pharmaceutical ingredients, new drugs, biotech products, and “life cycle drugs” (i.e., generics). OPQ also will bring together microbiologists for all products to provide a unified approach to microbiology.
A new Office of Surveillance in OPQ will oversee quality performance at facilities through pre-approval and routine inspections, with an eye to evaluating if an operation meets performance metrics that indicate a quality operation. And a Policy Office will issue guidance and regulations, while ensuring consistency in CDER actions. Surveillance will be enhanced by CDER gaining more complete information on its inventory of establishments, an undertaking that ideally will lead to less frequent field inspections.
Another theme is to “mitigate risks” by applying appropriate measures and analytical methods to different products. Woodcock expects risk assessment for every product to evaluate critical issues and employ statistically valid sampling.
The main aim of this reorganization is to achieve a “culture of quality in industry,” Woodcock said at the ISPE meeting. These plans will require considerable change within FDA and in industry, and manufacturers, she added, have to recognize that there is a “cost to poor quality.”