The Center for Drug Evaluation and Research's reorganization and elevation of its Office of Compliance is targeted at bringing a stronger focus to issues involving pharmaceutical supply chain integrity.

CDER's Office of Compliance is being elevated to "super-office" status, and one of its newly created subordinate offices will be dedicated to the challenges involving counterfeits, imports and recalls.

The changes were announced by CDER Director Janet Woodcock in a May 26 "all hands" memo.

Under the reorganization, the Office of Compliance will become the fifth super-office within CDER. The others are the Office of New Drugs, Office of Pharmaceutical Science, Office of Planning and Informatics, Office of Translational Sciences and, most recently, the Office of Surveillance and Epidemiology (Also see "CDER Reorganization Creates Drug Safety “Super-Office”; Management Support Is Goal" - Pink Sheet, 4 April, 2011.).

Responding To Globalization

Woodcock said the change in status for the compliance unit, which will continued to be called the Office of Compliance, is directed at addressing the increasingly globalized nature of the pharmaceutical industry.

"The reorganization will enable Compliance to align its scientific, technical and legal capabilities with closely related program areas, leveraging our resources and maximizing its ability to achieve its public health mission," Woodcock said.

She noted that OC's responsibilities include ensuring compliance with requirements for good manufacturing practice, good clinical practice, human subject protection, adverse event and drug quality reporting, Risk Evaluation and Mitigation Strategies, drug approval and labeling, importation and supply chain integrity.

The newly designated super-office will have three office-wide functions: risk science, intelligence and prioritization; policy and communication; and organizational strategy, which includes strategic planning, organizational development and quality management systems. "These are key components of a high-functioning, policy-driven, risk-based organization, and their elevation and integration in the CDER/OC structure promises to help CDER/OC to continue to evolve and grow," Woodcock said.

New Drug Security Office

OC currently houses four divisions: Division of New Drugs and Labeling Compliance (DNDLC); Division of Manufacturing and Product Quality (DMPQ); Division of Compliance Risk Management and Surveillance (DCRMS); and Division of Scientific Investigations (DSI).

As a super-office, OC will house four subordinate offices. However, these newly named offices do not necessarily reflect the simple elevation of existing divisions to office status. Rather, various functions and teams have been moved among the entities as part of the regrouping, and Woodcock said the new structure is "designed to align critical functions with new and existing program areas."

The reorganization will create an entity dedicated to drug security. The Office of Drug Security, Integrity and Recalls (ODSIR) will comprise two divisions: Import Operations and Recalls (encompassing the Recalls Coordination Branch and the Import Operations Branch), and Supply Chain Integrity.

Currently, the Recalls and Shortages Branch is housed in DMPQ, while the Imports and Exports Team is located in DNDLC. There is no existing entity dedicated to supply chain integrity, according to CDER's list of key officials.

ODSIR "is dedicated to addressing the challenges of globalization and an increasingly complex drug supply chain," Woodcock said. "ODSIR staff 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."

Two Divisions Retain Their Names

Two of OC's four existing divisions will become offices under the same name.

The new Office of Manufacturing & Product Quality will encompass four divisions: International Drug Quality; Domestic Drug Quality; Policy Collaboration & Data Operations; and GMP Assessment. The latter division includes three branches broken down by biotech, new drug and generic drug manufacturing assessment.

The new Office of Scientific Investigations will encompass three divisions: Bioequivalence and Good Laboratory Practice Compliance; Good Clinical Practice Compliance; and Safety Compliance. The safety compliance division includes the Post-Market Safety Branch and the Human Subject Protection Branch.

The fourth office under the new structure is the Office of Unapproved Drugs and Labeling Compliance, which houses two divisions.

The Division of Prescription Drugs includes the Prescription Drugs Branch and the Compounding and Pharmacy Practices Branch. The Division of Non-Prescription Drugs & Health Fraud similarly encompasses two branches: Over-the-Counter Drugs, and Health Fraud and Consumer Outreach. These functions were previously housed in DNDLC.

The current's structure's DCRMS did not survive the transition to the new structure. It appears that the division's drug surveillance and data reporting operations will now be housed in the Office of Manufacturing and Product Quality's Division of Policy, Collaboration and Data Operations.

Deborah Autor, OC director for the past five years, will serve as acting director of the new super-office.

- Sue Sutter (s.sutter@elsevier.com)

CDER's Newest "Super-Office" Focuses On Drug Security

More from Archive

More from Pink Sheet