FDA Revamps to Meet New Challenges - Pharmaceutical Technology

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PharmTech Europe

FDA Revamps to Meet New Challenges
Added responsibilities and outside concerns prompt overhaul of agency's structure.

Pharmaceutical Technology
pp. 22-26

"Super" changes at CDER

Woodcock looks forward and back
Parallel to the restructuring of FDA's top management, CDER Director Janet Woodcock has engineered operational changes that also seek to deal with globalization and overcome obstacles to new drug development. Growth in responsibilities and in staff has prompted the elevation of nearly all of CDER's main operating units into "super offices" with broader management structures better able to monitor diverse operations.

Figure 2: New structure for the Office of Compliance within FDA’s Center for Drug Evaluation and Research, as of November 2011.
In May 2011, Woodcock added the Office of Surveillance and Epidemiology (OSE) to the super-office list, joining the Office of New Drugs, Office of Pharmaceutical Science, and Office of Translational Sciences. OSE Director Gerald Dal Pan gained more support staff for his immediate office, plus for two subordinate offices: the Office of Medication Error Prevention and Risk Management and the Office of Pharmacovigilance and Epidemiology. The various divisions of these larger operators manage CDER's adverse-event reporting system, oversee sponsors' observational studies, prevent medical errors caused by product names, and orchestrate risk-management programs. The move aims to highlight the importance of drug-safety issues and hopefully quiet those who want to shift drug safety out of CDER and into an independent entity.

Figure 3: New structure of the Office of Manufacturing & Product Quality within FDA’s Center for Drug Evaluation and Research, as of November 2011.
Next, Woodcock unveiled a new structure for CDER's Office of Compliance, making it another super office with multiple suboffices and divisions (see Figure 2). Ilisa Bernstein has been OC acting director since Autor left last summer. While many OC functions remain fairly constant, a new Office of Drug Security, Integrity & Recalls was created to address the challenges of globalization and growing drug counterfeiting and diversion (see the August 2011 Washington Report column, "FDA Maps Strategy to Counter Supply-Chain Threats"). The Office of Manufacturing and Product Quality oversees field inspections and compliance with GMPs (see Figure 3). An increasingly visible function is to prevent and mitigate drug shortages related to manufacturing and compliance issues. A larger Office of Scientific Investigations now monitors pharmacovigilance and REMS programs, in addition to the conduct of clinical trials and human subject protection.

More recently, CDER's Office of Medical Policy (OMP) also became a super office. Led by Rachel Sherman, OMP consists of the Office of Prescription Drug Promotion (formerly the Division of Drug Marketing, Advertising, and Communications) and the new Office of Medical Policy Initiatives. This last entity will oversee FDA's Sentinel Initiative for modernizing drug surveillance and adverse event detection; the Clinical Trials Transformation Initiative to modernize trial conduct and oversight; and the Patient Medication Information project which seeks to update FDA policies for communicating risk information to the public. A key task is to support health reform initiatives related to biosimilars and other policy issues.

All the new acronyms are confusing, and critics are skeptical about so many "super" offices within CDER. Woodcock sees these changes as leading to "a high-functioning, policy-driven, risk-based organization" that can "evolve and grow." And with any luck, CDER's new management structure will provide more time for Woodcock to examine drug regulatory operations more broadly and explain its actions and policies to its many constituents.

Jill Wechsler is Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634,


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