FDA’s Center for Drug Evaluation and Research and its Office of Regulatory Affairs (ORA) will work more closely together.

In an August 31^st post to the FDA blog FDA Voice, FDA Commissioner Scott Gottlieb announced that FDA’s Center for Drug Evaluation and Research (CDER) and its Office of Regulatory Affairs (ORA) are implementing a new concept of operations agreement that will more fully integrate the agency’s drug review programs with its facility evaluations and inspections for human drugs.

The move, according to Gottlieb, was made in response to the increasingly complex and global nature of drug manufacturing and follows the restructuring of FDA’s field activities around regulated programs rather than geographic locations. The restructuring of the ORA is intended to better align FDA staff expertise and allow for more efficient use of the agency’s resources.

The new agreement will make use of this newly restructured approach and “Integrated Quality Assessment” teams, the latter of which, according to Gottlieb, will align field and review staff so that FDA can “make closer consideration of all elements that create risk including the drug substance, the drug product, manufacturing processes, and the state of the facilities we regulate”.

Gottlieb also noted that: “The unifying hallmark of the integrated quality assessment team and the concept of operations agreement is the closer integration of the professional staff charged with inspecting facilities and the review staff involved in evaluating applications. Experts in our drug program, and our field force, will be aligning their efforts. We believe that this sort of collaboration can better inform the work done across each of these domains. Our inspectional force will benefit from insights that might be offered by the review teams who have carefully evaluated products being manufactured. Meanwhile, our review staff will benefit from the deeper understanding they will glean through more direct and regular contact with the professionals who are inspecting facilities and seeing the kinds of things that can go wrong during the manufacturing process. We know this sort of team-based approach improves our oversight, and better informs our shared endeavors.” 

The new concept of operations agreed to by CDER and ORA has the approval of CDER Director Janet Woodcock and FDA’s Associate Commissioner for Regulatory Affairs Melinda Plaisier. It outlines the responsibilities and workflow that CDER and ORA employees will follow. The new approach will apply to Pre- and Post-Approval Inspections, Surveillance Inspections, and For-Cause inspections at domestic and international drug manufacturing facilities that FDA oversees. The agency will be implementing the approach this fall.

Gottlieb believes that the increased efficiency that will be achieved with this approach will enable FDA to meet its commitment under the Generic Drug User Fee Amendments II to communicate final surveillance inspection classifications to facility owners within 90 days of an inspection.