Major and Sweeping Changes coming to the FDA |

Major and Sweeping Changes coming to the FDA


Like the British navy sailing to the Falkland Islands, the Food and Drug Administration (FDA) has been signaling that big changes are afoot in 2014 in how the agency will be reorganized.

In late 2013, the agency announced it would need to “realign” its programs to keep up with “unparalleled challenges” posed by advances in science, globalization and product complexity.

On February 4, 2014, Regulatory Focus writer Alexander Gaffney reported that FDA Commissioner Margaret Hamburg, M.D. has unveiled major and sweeping changes to the agency which will see the agency’s many divisions reorganize in an attempt to “become more specialized and able to address increasing scientific and regulatory complexity.”

He reports that in a memo to all heads of FDA’s regulatory centers, Hamburg said that recommendations made by an internal “Program Alignment Group” (PAG) 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.”

Commodity-Based and Vertically-Integrated

Hamburg said the PAG had unanimously recommended that the agency’s regulatory and compliance activities “be organized around distinct commodity-based and vertically-integrated regulatory programs.” In other words, paraphrased Gaffney, 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.

All regulatory centers have until October 2014, to come up with an implementation plan.

Rise of ORA

Hamburg said that the Office of Regulatory Affairs (ORA) will be more fully aligned with centers, but at the same time will not lose operational, organizational or fiscal resources.

According to Gaffney, Hamburg noted PAG’s endorsement of more specialized resources, saying that some medical devices have 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.

Each center now develops its own annual work plan. But now, says Hamburg, 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.”

More Specialization and ORA University

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.

Performance-Based Metrics

With respect to compliance, Gaffney wrote that 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.

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.

Regulatory staffs and journalists love this stuff. Job security.

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