FDA, Reorganization and the Four Crises

In previous posts, FDA Matters has expressed its disdain for efforts to solve problems by reorganizing government agencies. So, it may be surprising that I am giving Commissioner Hamburg an “A” for her recent reorganization of FDA’s senior management.
In the reorganization, she is addressing four crises that beset the agency: industry discontent with the medical product review process; public concern about import safety; implementation of the Food Safety Modernization Act; and Congressional concerns that the agency is inefficient in its use of resources. The new structure should drive better decisonmaking and greater productivity…. at a time when the agency is struggling to fulfill its growing mission and faces the potential for budget cuts.
Until the beginning of this year, Dr. Hamburg has relied upon Dr. Joshua Sharfstein, a trusted deputy and alter-ego, to assist in managing the agency. In addition, he had served as a buffer between the agency and external forces, particularly Congress.  Instead of replacing Dr. Sharfstein, the Commissioner has chosen a new organizational approach that responds to the agency’s most difficult challenges:

  • Crisis #1: Growing discontent among the medical product industries. They allege that unreasonable FDA requirements and the agency’s overly-cautious approach to potential safety issues are keeping innovative and effective products from becoming available to patients. For more details, see my columns at:  http://www.fdamatters.com/?p=1428 and http://www.fdamatters.com/?p=1401.Response: Create a new Deputy Commissioner for Medical Products and Tobacco and appoint Stephen P. Spielberg, MD., PhD, a distinguished physician and researcher and former dean of Dartmouth Medical School. He also spent 11 years in industry, working for Merck and then J&J.

    In his new role, Dr. Spielberg will oversee the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health and the Center for Tobacco Products.

    The intent is for him to serve as a “senior partner” to the four center directors, facilitating decisions that might otherwise wait for the Commissioner. When appropriate, he would also stand-in for the Commissioner on their behalf. Right now, these center directors can’t be getting very much of Dr. Hamburg’s time and they are quite vulnerable on the Congressional side.

    In addition to the stature he brings, Dr. Spielberg’s bio describes his research interests as: mechanisms of idiosyncratic adverse drug reactions, human pharmacogenetics and personalized medicine, and pediatric clinical pharmacology. This background is germane to the areas of industry concern about pre- and post-market review of medical products and also positions him to be one of the agency’s chief advocates for improvements in regulatory science.

  • Crisis # 2: The safety and quality of imported food and medical products.  The American people and Congress want safe products and expect FDA to use its very limited resources to make it so. For more details, see my column here.Response: Create a new Deputy Commissioner for Global Regulatory Operations and Policy and appoint Deborah Autor, now Director of CDER’s Office of Compliance. Her “directorate” will oversee the Office of Regulatory Affairs (ORA) and the Office of International Programs.

    The intent is to increase coordination and greatly reduce the number of decisions that would otherwise wait for the Commissioner’s availability. Just as importantly, the new structure brings together FDA’s overseas relationship and capacity-building successes with a tougher, more regulatory posture to assure that imports meet the same standards for safety and quality as domestic goods.

  • Crisis #3: Implementation of the new Food Safety Modernization Act to create a sophisticated risk-based food safety system. This is a complex multi-faceted task being made more difficult by inadequate funding.Response: Continue the existing position of Deputy Commissioner for Foods, which oversees the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine. Michael Taylor, who will continue in this post, has already demonstrated the advantages of Dr. Hamburg’s new organizational approach….by his general leadership and his representation of the agency with Congress on food issues.
  • Crisis #4: FDA’s ability to sustain and grow its FY 2011 funding level is being challenged in the Congressional appropriations process.Response: Create a new Office of Operations, headed by a Chief Operating Officer (COO) to oversee human resources, facilities, information technology and finance. This will strengthen the agency’s ability to respond to Congress on administrative matters and, in particular, assure Congress that the agency is under tight fiscal management.

Conclusion: FDA has many problems, some of which are reaching crisis-proportion. While more resources are necessary, good leadership is essential.

Regardless of the demands, Commissioner Hamburg can never have more than 24 hours each day to address the agency’s needs. The new organizational arrangement—with four deputy commissioners providing span of control over most of the agency–seems well-suited to address this limitation.

Here is a link to read the Commissioner’s message to agency employees conveying the new organizational structure.  I would hope in the future that FDA would post these types of communications directly onto the agency website, rather than relying on the Commissioner’s messages to be reprinted in newsletters and blogs.

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adapted and republished with permission from FDA Matters.

2 thoughts on “FDA, Reorganization and the Four Crises

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