FDA Moves Forward with Inspection Overhaul

FDA’s Office of Regional Affairs (ORA), which manages the agency’s 5000 field inspectors, plans to “stand up” its much-anticipated Program Alignment Group (PAG) initiative by May 15. The aim is to implement this major reorganization of the FDA field force in fiscal year 2017, as promised more than two years ago.

The change involves shifting to specialized inspection cadres for drugs, biologics, medical devices, food, and other regulated products. ORA will maintain 20 district offices across the United States; some will concentrate on certain product areas, such as food or drugs, with additional specialists covering other areas.

The PAG was announced in 2014, and FDA Centers issued PAG Action Plans in 2015 for shifting to the envisioned commodity-based, vertically integrated inspection program. The initiative emphasizes the need for specialized, highly trained investigators able to identify and respond effectively to “questionable conditions” and to provide more timely information on quality problems and achievements of manufacturers. There was talk of the program launching last November, and there remains uncertainty that it will move ahead as now planned with FDA gaining a new commissioner and other officials that could seek to review such a major organizational change.

Under the PAG, ORA now has senior-level program directors at FDA headquarters in Maryland who oversee operations for six main product areas: food, biologics, drugs, medical devices, bioresearch monitoring (BIMO), and tobacco, plus operations involving imports and ORA laboratories. Ginette Michaud is program director for biologics, which includes blood products, tissues, vaccines, and other products overseen by the Center for Biologics Evaluation and Research (CBER). Alonza Cruse is pharmaceutical quality program director and leads PAG collaboration efforts for drugs regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Veterinary Medicine (CVM). Additional program directors head similar efforts on bioresearch monitoring, human and animal foods, and medical devices.

Each district office will have a director, plus program managers to head inspection cadres at that location. ORA plans to roll out more details and organizational information over the coming weeks, explained Michaud at the WCBP Symposium sponsored by CASSS in Washington, DC in January 2017.

A key goal of the PAG reorganization is to enhance communications and collaboration between field inspectors and Center product specialists. CDER’s Office of Process and Facilities (OPF) in the Office of Product Quality (OPQ) works closely with ORA pharmaceutical inspectors to provide an integrated quality assessment from a preapproval inspection. OPF has three groups of specialists to assess information in new drug applications on facilities, processes, and microbiology. Data in an application can facilitate an inspection, while inspection information can support application review, commented David Doleski, OPF deputy director, at the WCBP symposium. OPF also is developing the New Inspection Protocol (NIP) to standardize and define elements that enable scoring and comparison of drug facility inspections. This initiative will expand to cover more inspections and manufacturers.

OPQ’s Office of Surveillance similarly collaborates with ORA on GMP inspections at plants. Staffers review inspection reports and other data, including a facility’s inspection history and type of products produced, to help determine the need and timing and extent of a surveillance inspection.