Posted 04 February 2014
By Alexander Gaffney, RAC
Margaret Hamburg, commissioner of the US Food and Drug Administration (FDA) has unveiled major and sweeping changes to the agency which will see the regulator's many divisions reorganize in an attempt to become more specialized and able to address increasing scientific and regulatory complexity.
Late last year, the FDA made a somewhat cryptic announcement: In response to "unparalleled challenges" posed by advances in science, globalization and product complexity, the agency would need to realign its programs.
The details of the planned realignment were scarce, but FDA let on that it would be led by a new "Program Alignment Group" (PAG) which would include all executive-level members of each of FDA's regulatory centers, as well as 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.
The memo went on to map out six core "initial areas" for the PAG to focus on:
- specialization across FDA's inspection and compliance functions based on 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 and training requirements to enhance and maintain FDA's 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
- compliance policy and enforcement strategies that are clear, current, outcome-based and effectively communicated
- laboratory optimization that increases specialization; alignment and collaboration between the Directorates, ORA, and the Centers; and enhances efficiency
- effective alignment to support ORA's implementation of FDA's regulatory programs
A Plan for Alignment
Now, nearly five months to the day after it first announced the formation of the PAG, FDA has unveiled its plans for a newly aligned agency.
In a memo to all heads of FDA's regulatory centers, Hamburg said the PAG's recommendations are being used to "chart a course for modifying Agency functions and processes to improve communications and collaboration and to clarify roles, responsibilities and decision rights across all agencies."
The group, Hamburg said, had unanimously recommended that FDA's regulatory and compliance activities "be organized around distinct commodity-based and vertically-integrated regulatory programs." In other words, there should be agency-wide alignment around pharmaceutical quality, medical devices, biological products, bioresearch monitoring and food/feed products.
"These programs should have governance and budgets that ensure that resources are allocated and devoted to strategies, priorities and goals and that FDA speaks with one voice on policies and operations related to any given commodity," Hamburg explained.
As part of this alignment, Hamburg said that ORA will be more fully aligned with centers, but at the same time will not lose operational, organizational or fiscal resources.
Hamburg also noted PAG's endorsement of more specialized resources, observing that some medical devices have no become so complex that it may require sub-specialists in one specific area just to be able to carry out effective oversight of a single manufacturer. This will require advanced training resources and new methods of management within ORA, she said.
Compliance officers will also need to specialize in some regards, Hamburg said. "The goal should be to have a cadre of compliance officers across the Agency who have a similar level of technical expertise as the specialized investigators and who can work more closely with Center experts on complex scientific, manufacturing or other regulatory challenges," Hamburg wrote.
As such, training will be crucial to the endeavor, Hamburg continued. ORA will be coordinating with the various regulatory centers to come up with collaborative training plans, which will be administered through the "ORA University" training platform.
New Compliance Approach
With respect to compliance, Hamburg said the PAG had agreed that each center should be charged with constructing a new program-based work planning regime to base compliance activities on risk factors, public health outcomes, past inspectional history and operational experience. Those activities would then be tracked with performance-based metrics "clearly demonstrating public health and compliance outcomes," she said.
Each center is now responsible for overseeing the development of an annual work plan. "The Centers and ORA will share responsibility for monitoring adherence to the work plan on a regular basis and will engage in regular communication and coordination to ensure that the work plan is accomplished."
Additional specialization activities will affect enforcement, imports, and laboratory testing.
De-Layering or Disruption?
In addition, Hamburg called for ORA and the regulatory centers to "de-layer" their management and review levels, "where feasible, in order to better enable FDA to take timely and appropriate action."
Hamburg said ORA will slowly evolve from a geographically-based model to one based on program or function. While this will call for commodity-specific offices and management, it will also require a separate plan, to be completed by June 2014.
All regulatory centers are also charged with coming up with an implementation plan for PAG's recommendations, to be completed no later than 1 October 2014.
Perhaps sensing some disruption given the myriad of changes coming down the pipeline, Hamburg said that "Above all, we will need to maintain unity as an Agency" as the plans go forward. "It will be important that we notify and explain these decisions to all [FDA} employees in consultation with our union colleagues," she added.