FDA Mulls Another Makeover; Looking To Integrate Agency Functions

FDA Commissioner Hamburg has appointed 10 officials to come up with a plan to realign the agency, with the goal of moving toward a “specialized program-based model.”

After making numerous tweaks to its offices over the past year FDA has decided that a more fundamental makeover is necessary to improve its operations.

FDA Commissioner Margaret Hamburg gathered a team of senior agency officials, dubbed the Program Alignment Group, to identify and develop plans “to modify FDA’s functions and processes.” In a Sept. 6 memo to PAG members Hamburg said one goal of the initiative is to better align operations and programs among the directorates, Office of Regulatory Affairs and centers to avoid duplication of function and effort.

“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,” Hamburg stated.

FDA did not provide further details. Asked what a “commodity-based program” is, an FDA spokesman replied that it is a “program based on commodities.” He added that the agency cannot comment on what this might look like and that it is too early to speculate on any possible changes in agency structure.

Some experts believe FDA wants to combine the functions of different entities.

Michael Swit, special counsel at Duane Morris, said this aligns with the approach experts expect FDA is considering for the proposed Office of Pharmaceutical Quality – combining inspection, review and compliance issues into a single office.

“A key concern I would have is how FDA will manage this process to ensure that it does not become the tail wagging the dog and interfere with daily achievement of FDA’s existing duties,” Swit said. “In addition, it also would raise concerns about how this would be implemented in the field, where inspectors sometimes wear multiple hats, inspecting more than one commodity (e.g., device, food, drug).”

OPQ Opposition May Signal Difficulties For Initiative

Center for Drug Evaluation and Research Director Janet Woodcock, one of 10 officials appointed to the Program Alignment Group, emailed CDER staff about its formation. She said the initiative will enable the drug center to continue modernizing its operations, which focus on the regulation of pharmaceutical quality. She cited the elevation of the Office of Generic Drugs to a super office last year and the plans to establish the new Office of Pharmaceutical Quality as part of this effort.

FDA’s Program Alignment Group Roster

• Bernadette Dunham, Director of Center for Veterinary Medicine
• Michael Landa, Director of Center for Food Safety and Applied Nutrition
• Karen Midthun, Director of Center for Biologics Evaluation and Research
• Melinda Plaisier, Associate Commissioner for Regulatory Affairs
• Jeffrey Shuren, Director of Center for Devices and Radiological Health
• Steven Solomon, Acting Deputy Associate Commissioner for Regulatory Affairs
• John Taylor, Acting Deputy Commissioner for Global Regulatory Operations and Policy
• Michael Taylor, Deputy Commissioner for Foods and Veterinary Medicine
• Janet Woodcock, Director of Center for Drug Evaluation and Research
• Mitchell Zeller, Director of Center for Tobacco Products

In a memo to staff last year Woodcock said the proposed OPQ would be “charged with overseeing quality throughout the life cycle of a drug.”

But if this office is to be a model for an agency-wide realignment there could be opposition among agency staffers. Gregory Geba resigned as director of the Office of Generic Drugs after eight months in the post, citing, among other reasons, the plan to move all generic drugs chemists into OPQ and the realignment of chemistry, manufacturing and controls functions (Also see "House Investigates Tenure Of FDA Medical Products Office Acting Head" - Pink Sheet, 20 May, 2013.).

Asked when the OPQ is to be established, an FDA spokesperson said it is still in development within CDER. A reorganization package must be submitted for review and approval within the agency and Department of Health and Human Services.

Hamburg indicated that the new initiative will also alter the organization of the centers.

“This move towards a specialized program-based model will take time and a level of organizational change across both the centers and ORA,” she stated. “Implementing this vision of vertical integration and streamlining of management and decision making will require discussion in the near term regarding roles and responsibilities, metrics and accountability, and decision rights.”

Hamburg requested the Program Alignment Group begin working on a core set of operational changes for these areas:

• Specialization across FDA’s inspection and compliance functions
• Collaborative development of training by ORA and the centers
• New work planning that improves FDA’s selection of firms, inspection frequency and compliance efforts
• Compliance policy and enforcement strategies
• Laboratory optimization that increases specialization, fosters program alignment and collaboration and enhances efficiency
• Center and ORA practices, processes, and resources “that are effectively aligned in order to support ORA’s implementation of FDA’s commodity-based and prevention-focused regulatory programs.”

The commissioner asked the group to report back to her in the next three months on its plans and the timing for addressing these issues.

How Far Will Reorganization Go?

Robert Pollock, senior advisor at Lachman Consultants, said FDA is trying to figure how to more efficiently carry out the mandates of new legislation. “I don’t know how much more efficiency the bureaucracy is going to be able to squeeze out,” he said. “I don’t think moving pieces on a chess board is going to solve the problem.”

Pollock, a former OGD acting deputy director who left the agency in 1995, cited FDA’s history of combining regulation of drugs and biologics in one center and then splitting them into separate centers. In 1982 the then-Bureau of Biologics merged with the then-Bureau of Drugs to form the Center for Drugs and Biologics. The combination ended in 1987 with the formation of CBER and CDER. In 2002 the two were again united, and split again two years later.

Over the course of its history FDA has reorganized countless times. In a major restructuring in 2011, Hamburg created directorates, a new layer of management and accountability between her office and the medical product center directors (Also see "FDA Becomes An Agency Of “Directorates” Under Hamburg’s Reorganization" - Pink Sheet, 18 Jul, 2011.).

When told about this new initiative one FDA expert responded, “Not again.”

But consultant Steven Grossman, of HPS Group, said that it makes sense for organizations to periodically evaluate their structure. He said there are two obvious questions: whether a CDER/CBER split still makes sense and where to place multiple types of combination products.

In a Forbes.com commentary, Scott Gottlieb, a resident fellow at the American Enterprise Institute, noted that regulation is increasingly based on the function of a product rather than its traditional classification as food, drug, device, biologic, or cosmetic. He questioned whether FDA will have “the fortitude to break up its existing functional divisions and adopt a real program orientation.”

Gottlieb, former FDA deputy commissioner for medical and scientific affairs, said there will be a lot of internal resistance and the agency is more likely to create a few model programs that cut across its existing centers.

“The focus is likely to fall on FDA’s post-market regime and its inspection resources, which right now reside across the different centers,” he said. “But the review functions will likely remain intact under the existing divisions.”