FDA’s Center for Drug Evaluation and Research (CDER) is elevating and restructuring its Office of Compliance (OC) to better reflect the regulatory challenges posed by an increasingly complex global supply chain and the recent growth of the office’s staff and responsibilities.
The compliance office will now have the status of a “super office” within CDER – placing OC on a par with the other CDER oversight offices such as the Office of New Drugs (OND) and Office of Pharmaceutical Science (OPS) that house subordinate offices within their organizational structures. Deborah Autor, who has served for five years as OC director, will head the new super office.
The former compliance office divisions, in turn, are being reorganized into the OC subordinate offices, with their former branches assuming division status.
For example, the Division of Manufacturing & Product Quality (DMPQ) will now be the “Office of Manufacturing & Product Quality” (OMPQ), with divisions focused on “International Drug Quality,” “Domestic Drug Quality,” “Policy, Collaboration & Data Operations,” and “Good Manufacturing Practice Assessment.” The GMP assessment division will focus on new drugs, generics and biotech products.
Former DMPQ Director Richard Friedman will fill the role of “Associate Director for Risk Science, Intelligence & Prioritization” for OMPQ – freeing him up from some of his former administrative duties to focus on the pressing regulatory policy issues that CDER faces in the new global and technologically complex environment. Each of the other three divisions in the new OC will also have an associate director focused on “risk science, intelligence and prioritization,” as well as associate directors for “policy and communication” and “program management and organization.”
Of particular significance is the creation of a new “Office of Drug Security, Integrity & Recalls” (ODSIR), which will be dedicated to addressing the emerging global supply chain challenges and threats.
The ODSIR staff, to be headed by former Division of New Drug & Labeling Compliance Director Michael Levy, will take the lead in dealing with issues such as supply chain security, counterfeit and diverted drugs, economically motivated adulteration, import operations and drug recalls.
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