In response to "unparalleled challenges" posed by advances in science, globalization and product complexity, the US Food and Drug Administration (FDA) is preparing to launch a new working group intended to adapt the agency to face current and future challenges.
The Program Alignment Group
The working group, known as the Program Alignment Group (PAG), will be comprised of executive-level members of every center in FDA, including the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH) and the Office of Regulatory Affairs (ORA).
"It is imperative that there be greater clarity and transparency about relative roles and responsibilities of the Directorates, ORA, and the Centers, as well as greater operational and program alignment among these organizations that avoids duplication of function and effort, if FDA is going to succeed in the future," the agency wrote in a memorandum distributed to high-level staff and obtained by Focus.
"More specifically, we need to transition to distinct commodity-based and vertically-integrated regulatory programs with well-defined leads, coherent policy and strategy development, well-designed and coordinated implementation, and a de-layered management structure," FDA added.
Core Areas to be Addressed
For now, the PAG is still very much in its infancy, having only been announced on 6 September 2013 by CDER Director Janet Woodcock and FDA Commissioner Margaret Hamburg.
The agency has, however, mapped out six core "initial areas" for the PAG to work on. Per the memorandum, those areas are:
- specialization across FDA's inspection and compliance functions, that enables the Agency to mirror, adapt to, and track the continuing program-based specialization within FDA's regulated industries and the demands of new legislation
- training that is developed collaboratively by ORA and the Centers and leads to the development of competency requirements, training curricula, certification/qualification/accreditation processes, performance assessments, and a continuing education program that enables FDA to enhance and maintain its world-class workforce
- new work planning that improves FDA's selection of firms, inspection frequency, and compliance efforts that is based on risk factors, public health outcomes, past inspectional history and operational experience, and that is reported through performance-based metrics clearly demonstrating public health and compliance outcomes
- compliance policy and enforcement strategies that are clear, current, outcome-based and effectively communicated in order to maximize FDA's ability to protect public health and to exercise effective and efficient industry oversight
- laboratory optimization that increases specialization; fosters program alignment and collaboration between the Directorates, ORA, and the Centers; and enhances efficiency within the current laboratory configuration
- center and ORA practices, processes, and resources that are effectively aligned in order to support ORA's implementation of FDA's commodity-based and prevention-focused regulatory programs
"To successfully implement these initial changes will take time, commitment, continued investment and evaluation, unity, and my support," Hamburg wrote in her memorandum. Initial appraisals of future opportunities will be generated within the next three months.
h/t to Peter Pitts at DrugWonks