With drug manufacturing and clinical-trial activities expanding overseas and at home, CDER's Office of Compliance is being
reshaped into a "super" office that can better manage its growing responsibilities. OC now has a staff of 300, compared with
118 in 2005, explained OC Deputy Director Ilissa Bernstein at the Parenteral Drug Association pharmaceutical supply-chain
conference in June. Now a string of top aides manages cross-cutting initiatives, including policy and communications, strategic
planning and organization development, data analysis, and risk assessment, directly under OC Director Autor. These staff functions
incorporate many of the data-management responsibilities of the former Division of Compliance Risk Management and Surveillance.
The main new OC component is the Office of Drug Security, Integrity, and Recalls (ODSIR), which will oversee import operations,
recalls, and a range of supply-chain issues. An Import Operations branch will coordinate import and export compliance activities,
including supplies for clinical and preclinical studies. The Division of Supply Chain Integrity (DSCI) will handle anticounterfeiting
strategies, track-and-trace initiatives, product authentication, good importer practices, good distribution practices, cargo-theft
prevention, intentional adulteration, and efforts to leverage domestic and international partnerships in these areas, explained
Leigh Verbois, who will serve as the DSCI deputy director.
Among other responsibilities, ODSIR Acting Associate Director Connie Jung will continue to lead agency efforts to develop
track-and-trace programs, building on guidance issued in March 2010 that outlines how manufacturers should provide a standard
numerical identifier (SNI) on every product as the basis for tracking products through the supply chain. FDA is digesting
comments from a February 2011 public workshop on how to develop interoperable standards that will facilitate adoption of pedigrees
and tracking systems, hopefully in time to help manufacturers meet California requirements.
With this reorganization, OC's status is similar to that of CDER's Office of New Drugs, Office of Pharmaceutical Science,
and Office of Surveillance and Epidemiology. Most OC divisions will function as before, though with slightly revised names.
The Office of Manufacturing and Product Quality (OMPQ) will no longer oversee recalls and shortages, but continues to manage
inspections for new and generic drugs and biologics, both domestic and international, to ensure compliance with GMPs. The
Office of Unapproved Drugs and Labeling Compliance (OUDLC) oversees drug fraud and labeling and approval requirements for
prescription and over-the-counter drugs. The Office of Scientific Investigations (OSI), which monitors clinical trial operations,
bioequivalence testing, and patient protections, gains a new division of safety compliance with responsibility for postmarketing
activities, including adverse event reporting and risk evaluation and mitigation strategies (REMS) .
The global market "contains a vast amount of counterfeit and substandard drugs," Bernstein commented at the PDA conference,
noting the need for more transparency and accountability in the supply chain, both upstream and downstream.
OMPQ Associate Director Richard Friedman emphasized that company management is ultimately responsible for ensuring product
quality, including use of safe and reliable raw materials and effective monitoring of outsourced activities. A significant
reason for the OC reorganization, Autor explains, "is to recognize the challenges of globalization" and to be able to focus
more on international collaboration, data mining, and risk analytics. "It fits together nicely and it's the right direction
for us to move in."
*As we went to press, FDA announced a major reorganization of the Commissioner's office, with Autor becoming FDA Deputy
Commissioner for Global Regulatory Operations and Policy. Ilisa Bernstein will serve as the Office of Compliance Acting Director.
Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634,