From: CDER Center Director
Sent: Friday, September 06, 2013 11:24 AM
Subject: FDA Establishes the Program Alignment Group
In order for FDA to best adapt to the ongoing rapid changes in the regulatory environment, driven by scientific innovation, globalization, the increasing complexity of regulated products, new legal authorities and additional user fee programs, the Commissioner has formed a Program Alignment Group (PAG). Comprised of senior Agency leaders, the PAG is charged with identifying and developing plans to modify FDA’s functions, processes, and possibly its structure in order to address these matters and best achieve mission-critical Agency objectives. This group of senior leaders will achieve this goal by working together to promote the strategic, operational, and resource management alignment needed for FDA to continue to fulfill its mission.
As a member of the PAG, I am pleased to share with you the email and memo (below) that I received from the Commissioner this morning. This initiative will provide an opportunity for CDER to continue modernization of operations in order to address the challenges noted above and to implement our new legislative responsibilities, including those imposed by the Food and Drug Administration Safety and Innovation Act and the Generic Drug User Fee Amendments of 2012 (GDUFA).
Many of CDER’s current modernization efforts center around the regulation of pharmaceutical quality. Most of you are aware of the proposed elevation of the Office of Generic Drugs to a super office, and the concomitant efforts to establish a new Office of Pharmaceutical Quality (OPQ). The work to establish OPQ will need to be closely coordinated with the Office of Regulatory Affairs (ORA). We recognize that in order to accomplish GDUFA and other commitments, CDER and ORA need to have an integrated program for regulating pharmaceutical quality, with well-defined leads, coherent policy and strategy development, well-designed and coordinated policy implementation, and a de-layered management structure. Moving toward this new model will take time and a level of organizational change across CDER and ORA, including streamlining management and decision making and clarifying roles and responsibilities, metrics and accountability, and decision rights. Similar considerations apply to other inspectional programs.
I am confident that any changes implemented as a result of this evaluation will not only improve efficiency in our program areas and in our collaborations across the Agency, but also provide us with a solid foundation that allows us to continuously adapt to the ever-changing challenges and new demands placed on CDER. This is important as we continue to meet our critical public health and regulatory mission to ensure safe, effective, and high-quality drugs are available to the American public.
I look forward to participating in the PAG discussions. The first report from the PAG is due to the Commissioner in the next several months. FDA will then assess the recommendations and decide how to proceed. I am committed to keeping you informed about the outcome of the PAG’s evaluation; you may expect additional communications from me once the Agency determines its next steps in this process.
From: Hamburg, Margaret
Sent: Friday, September 06, 2013 10:09 AM
To: Dunham, Bernadette M; Landa, Michael; Midthun, Karen; Plaisier, Melinda K; Shuren, Jeff; Solomon, Steven M; Taylor, John M.; Taylor, Michael R; Woodcock, Janet; Zeller, Mitchell
Subject: Program Alignment Group
Over the past few years, FDA has experienced unparalleled challenges and demands posed by the increasing breadth, depth, and complexity of the products it regulates. That, combined with significant strides in scientific innovation and increased biomedical discovery, the globalization of the food system and medical supply chains, as well as the expansion in FDA’s regulatory authorities via many new forms of legislation, require the Agency to continue to find ways to ensure that we are meeting our critical public health and regulatory mission.
Therefore, to be in the best position to effectuate the steps necessary to successfully address these challenges, I am pleased to formally appoint you to the Program Alignment Group (PAG). The PAG will be comprised of senior Agency leaders charged with identifying and developing plans to modify FDA’s functions and processes in order to address the challenges noted above and to best achieve mission-critical Agency objectives. This group of senior leaders will attain this goal by working together to promote the strategic, operational, and resource management alignment needed for FDA to continue to fulfill its public health mission.
More information about the PAG can be found in the attached memorandum. The group will look at what changes may be necessary from an operational standpoint to transform the Agency from a domestic Agency operating in a globalized world to a truly global Agency fully prepared for a regulatory environment in which product safety and quality know no borders.
I want to thank you, as senior FDA leaders, for engaging in this important work together to move FDA into the future as a modern and globalized public health-regulatory Agency. I look forward to watching your progress in the months ahead as we embark on this path together.
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs