• FDA to Undergo Changes As Recommendations for Re-Alignment are Released Amid "Unparalleled Challenges" Posed By Product Complexity and Globalization
  • January 23, 2015
  • Law Firm: Loeb Loeb LLP - Los Angeles Office
  • More than a year after its creation, the Program Alignment Group (PAG) issued final recommendations on how to realign the FDA, releasing six distinct "Action Plans" in a bid to improve the agency’s structure and regulation. The action plans represent the critical actions to fulfil the FDA’s mission in the key areas of specialization; training; work planning; compliance policy and enforcement strategy; imports; laboratory optimization; and information technology.

    The PAG, composed of senior FDA officials, was created in 2013 to identify and develop plans to adjust the FDA’s functions, processes and structure. The changes are aimed at meeting the challenges posed by scientific innovation, globalization, the increasing scope and complexity of the products regulated by the FDA, and new legal authorities.

    Officials were charged with developing action plans to revise the FDA’s functions and processes to address these challenges. The Directorates, Centers and the Office of Regulatory Affairs (ORA) worked closely to define the changes required, resulting in each regulatory program establishing detailed action plans.
    FDA Commissioner Margaret Hamburg said that the revamp would more fully align ORA centers without losing operational, organizational or fiscal resources. Hamburg also noted the PAG’s endorsement of more specialized resources, as some medical devices are now so complex that it may require sub-specialists in one specific area to be able to perform effective oversight of a single manufacturer, saying this would necessitate advanced training resources and new methods of management within ORA.
    Concerning compliance, the PAG found that centers should be charged with creating new program-based work planning regimens that use risk factors, public health outcomes, past inspectional history and operational experience as the basis of compliance activities.
    Notable changes recommended in the action plans include the creation of "senior executive program directors" in ORA, giving the centers a single senior executive responsible for each commodity program, as opposed to having several ORA units responsible for given programs.
    Also, centers will work to develop new inspection approaches, with the Center for Devices and Radiological Health working with ORA to focus inspection on critical medical device characteristics and features, for example. Hamburg also said that at the Center for Biologics Evaluation and Research, ORA will work on crafting a biologics training curriculum and new certification tools for its inspectors.
    In a broader sense, the FDA will also be developing a multi-year plan to enhance the quality of its scientific laboratories, hiring new analysts and buying new equipment to ensure cutting-edge products can be regulated. The majority of major changes will come in the first two quarters of 2015, with more substantial modifications taking even longer.