FDA’s Program Alignment: More Questions Than Answers

In February 2014, then FDA Commissioner Margaret Hamburg issued a memorandum directing all Centers and the Office of Regulatory Affairs (ORA) to develop a plan for more collaboration and efficiency in operations.  As a result of this mandate, the Centers and ORA have developed fiscal year plans to move toward a distinct commodity-based, vertically-integrated regulatory structure.  As further described in part on FDA’s website:

“***The Pharmaceutical Program 5-Year Plan developed in FY15 is a high-level multi-year plan to guide the operational changes needed to reach the Commissioner’s vision of distinct commodity-based and vertically-integrated regulatory programs. *** The FY16 Action Plan is intended to facilitate operational and program alignment as FDA transitions to distinct commodity-based and vertically-integrated regulatory programs with well-defined leads, coherent policy and strategy development, and well-designed and coordinated implementation. Core elements of Action Plans will include increased specialization, de-layered management decisions and processes involving ORA and the Centers, jointly developing training programs, new work planning models, strategic enforcement approaches with aligned and updated compliance programs and policy, strategic import approaches, laboratory optimization, and coordination of internal and external communication on the Action Plan to ensure that FDA speaks with one voice on the policies and operations related to the pharma program.”

In June 2016, FDA’s ORA senior leaders addressed components of the program alignment progress during the 120th Association of Food and Drug Officials (AFDO) Annual Educational Conference in Pittsburgh, PA. For example:

The Center for Drug Evaluation and Research (CDER) initiated for the first time, a fiscal year 2016, national, risk-based initiative for work planning, which determined which firms were to be inspected, both foreign and domestic.  The goal of FDA is to use tracking of metrics and signals, to develop robust, risk-based work plans in collaboration with and across all Centers.  Some of these signals include a more global approach to inspectional outcomes, considering firms with multiple sites as a whole when it comes to assessing compliance.  Further, the concept of corporate culture continues to be at the forefront of FDA’s mind.

ORA has issued programmatic assignments to field staff thus, beginning to establish a dedicated work force aligned by commodity.  The alignment would encompass investigators, compliance officers and directors all working in a single commodity area, in close collaboration with the commodity Center.  This represents a move from a geographically distinct work force across 20 ORA Districts to an alignment of staff located throughout the country and organized by commodity, regardless of geographical stationing.

These and other highlights of the Agency’s progress under this alignment program presented at the AFDO Conference raised pressing operational questions from attendees pertaining to facility inspections, for example:

  • What will determine a facility’s risk score, landing them on the list for inspection?
  • Will facilities producing multiple commodities be subjected to multiple FDA inspections if the investigators are aligned and trained in only one commodity?
  • If one site under the same ownership receives an FDA Form 483, or a Warning Letter, does that mean all other sites will be inspected?
  • How will industry communicate with geographically distributed FDA staff if there is no longer a District structure and point of contact?
  • Does this alignment plan mean that facilities may be seeing new investigators during inspections perhaps from a completely different part of the country?

Answers to these questions were not readily available.  Conference attendees urged timely, clear communication to the regulated industry regarding seemingly vast changes in the organizational structure and inspectional strategies moving forward.  One thing is certain, the game is changing and  the “playbook” is in development.

Stay tuned to this blog for future updates and answers to these and other questions as FDA’s plans, policies and procedures are announced.