FDA Announces Major Regulatory Changes, With Specialization a Key Focus


In September 2013, FDA announced to internal staff that, in response to “unparalleled challenges” posed by advances in product complexity and globalization, FDA would be forming a new “Program Alignment Group” (PAG) to better structure the agency to meet current and future challenges.  “It is imperative that there be greater clarity and transparency about relative roles and responsibilities of the Directorates, Office of Regulatory Affairs (ORA), and the Centers (CDER, CDRH, CBER, CFSAN, CTP), 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 group’s wide remit was focused on six different areas, FDA said:

  • specialization across FDA’s inspection and compliance functions;
  • better training for FDA employees co-developed by their respective FDA Center and ORA;
  • new ways of deciding which firms should be inspected based on risk factors and public health;
  • compliance policy and enforcement strategies that are clear, current, outcome-based and effectively communicated;
  • laboratory optimization that increases specialization and enhances efficiency within the current laboratory configuration; and
  • align resources and practices to support ORA’s implementation of FDA’s commodity-based and prevention-focused regulatory programs.

By February 2014, emerging details confirmed that FDA’s PAG was making considerable progress.

Emerging Details…

The group, FDA Commissioner Margaret 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, bio-research monitoring (BIMO) 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 FDA 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 now 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.

And 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.

Plan Released

Now, more than a year after FDA first announced the creation of the PAG, the group has come back with final recommendations regarding how to overhaul FDA.  Those recommendations, contained in six distinct “Action Plans” released on 7 October 2014, are the blueprints by which FDA plans to prepare for the future, Hamburg said in a statement.  “These action plans focus on what will be accomplished in FY 2015 and outline the need to develop detailed future plans for the next five years in some cases,” Hamburg wrote.  And while each FDA Center will have its own area to focus on, Hamburg did call out several notable changes being undertaken.  For example, FDA plans to establish “senior executive program directors” in ORA.  “In the past … the Center for Drug Evaluation and Research (CDER) would work with several ORA units responsible for the pharmaceutical program,” Hamburg recounted.  “Now, the Centers will have a single Senior Executive in ORA responsible for each commodity program, allowing ORA and the Centers to resolve matters more efficiently.”

Centers will also be working on developing new inspection approaches, Hamburg said.  For example, the Center for Devices and Radiological Health (CDRH) will work with ORA to focus inspection “on characteristics and features of medical devices most critical to patient safety and device effectiveness.”

And over at the Center for Biologics Evaluation and Research (CBER), ORA will be working to develop a biologics training curriculum and new certification tools for its inspectors, Hamburg said.

More broadly, FDA will also be working on a multi-year plan to increase the quality of its scientific laboratories, hiring new analysts and purchasing new equipment to make sure they’re able to regulate cutting-edge products.

Most major changes will be forthcoming in the first two quarters of 2015, with more substantial changes taking even longer.

REFERENCE:  RAPS Regulatory Focus; 08 OCT 2014; Alexander Gaffney, RAC

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