FDA Increasing Communication Between Reviewers and Inspectors

July 18, 2008

The FDA is conducting a pilot program aimed at increasing communications between drug reviewers and inspectors in its preapproval inspections (PAI) program, according to an agency director.

Richard Friedman, director of the Division of Manufacturing and Product Quality, told attendees last month at the International Society for Pharmaceutical Engineering’s 2008 Engineering Regulatory Conference that the FDA has been working to create a formal communication mechanism in the program.

“We’re working on a pilot to test these procedures and hopefully ... you’re going to see a stronger link between the center and [Office of Regulatory Affairs] operations and thus a more effective FDA regulatory system overall,” Friedman said. “We’ll be asking investigators … to focus their inspections on areas where data may be lacking, the overall manufacturing control strategy raises issues that need inspectional evaluation or the manufacturing concept includes apparent weaknesses.”

ORA, the Office of Compliance, the Office of Generic Drugs and the Office of New Drug Quality Assessment have been working on the program, he said. The pilot is the first step in integrating FDA field operations to promote continuity from application review and compliance to inspection, he added.

The program will incorporate a knowledge transfer mechanism between reviewers and inspectors. Questions a reviewer has regarding an application would be communicated to an inspector, who would look for answers during the PAI, he said.

In addition to the pilot program, the agency is looking to build its pharmaceutical inspectorate, a group with specialized expertise. The FDA wants to expand it from 11 to 50 inspectors, Friedman said. A number of candidates have almost completed training to become members of the group.