FDA Office of Compliance to Become a Super Office - - BioPharm International

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FDA Office of Compliance to Become a Super Office


BioPharm Bulletin

The FDA Center for Drug Evaluation and Research’s Office of Compliance is undergoing some major structural reorganization, according to an internal letter to the CDER staff from Director Janet Wookcock, dated May 26, 2011, which was shared with Pharmaceutical Technology by the agency press office. Specifically, the Office of Compliance will be elevated to a “Super Office.” Similar offices exist within CDER including the Office of Pharmaceutical Science. The change means that the Office of Compliance will house subordinate offices, including four new offices, three of which are similar to existing divisions, according to the letter. The new fourth office will be called the Office of Drug Security, Integrity & Recalls (ODSIR) and will focus on addressing the challenges of globalization and an increasingly complex drug supply chain. This includes dealing with supply-chain security, counterfeit and diverted drugs, economically motivated adulteration, import operations, and drug recalls, according to the announcement.

“Given CDER/OC’s expanding role, size, and importance in achieving the Agency’s mission of safeguarding the US drug supply, this structural transition makes a great deal of sense,” wrote Woodcock. “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. CDER/OC’s responsibilities include ensuring compliance with requirements relating to good manufacturing practice, good clinical practice, human subject protection, adverse event and drug quality reporting, REMS [risk evaluation and mitigation systems], drug labeling, drug approval, drug importation, and supply chain integrity, among many others.”

The new Super Office will have three primary functions: risk science, intelligence, and prioritization; policy and communication; and organizational strategy, which involves 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,” wrote Woodcock.

As part of the reorganization, Deborah Autor, who has been leading the Office of Compliance, will take on the role of Acting Director of the new Compliance Super Office. The staff will be realigned according to critical functions within the new and existing program areas. The Super Office will still be called the Office of Compliance.

For a visual of the new structure, view a PDF. Otherwise, the structure is outlined below.

The Office of Compliance Super Office

Office of Drug Security, Integrity & Recalls
• Division of Import Operations & Recalls
• Recalls Coordination Branch
• Import Operations Branch
• Division of Supply Chain Integrity

Office of Manufacturing & Product Quality
• Division of International Drug Quality
• International Compliance Branch 1
• International Compliance Branch 2
• Division of Domestic Drug Quality
• Domestic Compliance Branch 1
• Domestic Compliance Branch 2
• Division of Policy, Collaboration & Data Operations
• Drug Surveillance and Data Reporting Branch
• Regulatory Policy and Collaboration Branch
• Division of Good Manufacturing Practice (GMP) Assessment
• Biotech Manufacturing Assessment Branch
• New Drug Manufacturing Assessment Branch
• Generic Drug Manufacturing Assessment Branch

Office of Scientific Investigations
• Division of Bioequivalence (BEQ) and Good Laboratory Practice (GLP) Compliance
• Bioequivalence (BEQ) Branch
• Good Laboratory Practice (GLP) Branch
• Division of Good Clinical Practice (GCP) Compliance
• GCP Enforcement Branch
• GCP Assessment Branch
• Division of Safety Compliance
• Post Market Safety Branch
• Human Subject Protection Branch

Office of Unapproved Drugs & Labeling Compliance
• Division of Prescription Drugs
• Prescription Drugs Branch
• Compounding and Pharmacy Practices Branch
• Division of Non-Prescription Drugs & Health Fraud
• Over-the-Counter Drugs Branch
• Health Fraud and Consumer Outreach Branch

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