FDA Moves to Implement New Site Inspection Program

FDA’s Office of Regional Affairs (ORA), which manages the agency’s 5000 field inspectors, plans to “stand up” its much-anticipated Program Alignment (PAG) initiative by May 15. The aim is to implement this major reorganization of the FDA field force in fiscal year 2017, as promised. The new program will alter bioresearch monitoring (BIMO) of clinical research operations, as well as inspections of manufacturing facilities for drugs, biologics and medical devices.

The change involves shifting to a commodity-based, vertically integrated inspection program, with specialized inspection cadres for FDA-regulated products and inspection operations. ORA will maintain 20 district offices across the U.S.; some will concentrate on certain product areas, such as food or drugs, with additional specialists covering other areas. BIMO inspectors will be distributed among the district offices to meet program needs.

The PAG was announced in 2014, and FDA Centers issued PAG Action Plans in 2015 for shifting to the new structure. The initiative seeks to establish teams of specialized, highly trained investigators able to identify and respond effectively to questionable conditions and to provide more timely information on operations at regulated entities. There was talk of a PAG launch last November, and there remains uncertainty that it will move ahead now with a new commissioner heading up FDA and other new officials who may seek to review such a major organizational change.

ORA already has named senior-level program directors at FDA headquarters to oversee operations for six main product areas:  food, biologics, drugs, medical devices, BIMO and tobacco, plus operations involving imports and ORA laboratories. Chrissy Cochran is BIMO program director, responsible for working with FDA product centers to establish and manage the new BIMO inspection program. Ginette Michaud is program director for products regulated 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 by the Center for Veterinary Medicine (CVM). And Jan Welch directs changes affecting medical devices and radiological health.

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 this week.

BIMO personnel conduct more than 1000 inspections a year, primarily of clinical investigators at research sites, but also of institutional review boards, contract research organizations, sponsor monitoring programs, and test laboratories utilized by sponsors and manufacturers in all regulated product areas. The BIMO Program Alignment Implementation Team has been developing training programs and best practices for inspections; assessing where new guidance and regulation is needed; evaluating resource and staffing needs; and identifying available ORA BIMO investigators.

The new BIMO program also will monitor postmarketing adverse drug experience reporting and risk evaluation and mitigation strategies (REMS) for certain drugs. And it will identify accredited third-party review activities for certain medical devices. A key goal of the PAG reorganization is to enhance communications and collaboration between field inspectors and Center product specialists, and that will be doubly complex for BIMO in dealing with multiple Centers.