FDA Revamps to Meet New Challenges

Added responsibilities and outside concerns prompt overhaul of agency's structure.
Dec 01, 2011
Volume 24, Issue 12

Jill Wechsler
Pressure to spur development of new medical products, deal with an increasingly global pharmaceutical supply chain, and accomplish more tasks with tighter budgets is prompting visible changes at FDA. Commissioner Margaret Hamburg took a broad look at the agency's long-established administrative structure following the departure of Deputy Commissioner Joshua Sharfstein at the beginning of the year, with an eye to meeting expanded regulatory assignments.

In recent years, Congress has called on the agency to regulate food quality more closely and to monitor tobacco marketing, while continuing to ensure the safety, quality, and efficacy of medical products. The result is a top-level reorganization that shifts daily management and decision-making to others, permitting the commissioner to focus more on crucial scientific and policy issues.


Figure 1: FDA organizational chart after recent restructuring by Commissioner Hamburg, as of November 2011 (www.fda.gov).
Most notable is the designation of a cadre of top deputies to oversee important agency functions (see Figure 1). Of particular importance to pharmaceutical and biotech manufacturers, a new deputy commissioner for medical products and tobacco, Stephen Spielberg, now coordinates the activities of FDA centers for drugs, biologics, medical devices, and tobacco products. Spielberg also will oversee a cluster of programs that affect all medical units, including offices for orphan drugs, pediatric therapeutics, combination products, and good clinical practices.

Another new deputy commissioner for global regulatory operations and policy, Deborah Autor, will manage FDA's Office of International Programs and the Office of Regulatory Affairs, which runs the agency's far-flung field force. This force includes FDA foreign offices, which have been established around the world to support oversight of an expanding volume of food and medical products imported into the United States. Autor is quite familiar with supply-chain vulnerabilities and difficulties related to surging imports. She previously headed the Office of Compliance (OC) within the Center for Drug Evaluation and Research (CDER), which also has been overhauled.

The explosion in foreign production of FDA-regulated products requires more collaboration and information exchange with established regulatory counterparts, according to Autor. "We can never get enough resources to cover all those facilities," she told the PDA–FDA Joint Regulatory Conference in September 2011. Autor also seeks to level the playing field between US-based and foreign manufacturers by gaining authority to block drugs from US markets if their producers limit or refuse FDA inspection or fail to comply with US quality standards. Autor anticipates further assessment of these approaches in a consensus study by the Institute of Medicine (IOM) on the global public-health risks from substandard, falsified, and counterfeit medical products.

These two new deputies join the head of FDA's Office of Foods, Michael Taylor, who oversees the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine. An FDA veteran, Taylor has the daunting task of implementing recent food safety legislation without the resources and personnel necessary to inspect more food facilities and to expand oversight as required.

Chief Scientist Jesse Goodman continues to lead important regulatory science initiatives. Goodman's office oversees the National Center for Toxicological Research, counterterrorism and threats, and professional development and integrity for FDA professionals. Special offices for women's health and for minority health fall under Goodman's purview, but also report to Hamburg.

Counselor to the Commissioner John Taylor, who served as Hamburg's temporary deputy commissioner for much of this past year, returns to his advisory role, but with specific staff responsibilities. He will manage policy and planning functions, legislative relations, and external affairs, which includes FDA's press office and liaison with the healthcare community.

Hamburg also is establishing a high-level office of operations with a chief operating officer to head the agency's increasingly complex administrative functions. These functions include information technology, finance, facility management, and budget formulation.

The aim of these organizational changes, Hamburg explained in a July 2011 announcement, is to establish a more effective management structure for an agency that now has 12,000 employees (1600 of which reside in the Commissioner's office) and is responsible for regulating more than 20% of US consumer products. The new structure reduces the number of officials reporting directly to the commissioner, while emphasizing the importance of innovation and science and the effect of globalization on FDA and regulated entities.

These changes also aim to address various criticisms of FDA's regulatory posture. Manufacturers claim that an overly-cautious approach to potential safety issues generates unreasonable requirements that keep innovative and effective products from patients, explained consultant Steve Grossman at the October FDA Inspections Summit sponsored by FDA Week. Patient and disease groups, particularly those involved with rare conditions, echo these concerns and are pushing for FDA to revise risk calculations so that promising therapies can reach the market without delay.

Yet, consumer representatives and some members of Congress continue to voice concerns about product safety. Demands for more extensive testing of new drugs both prior to approval and after coming to market led to provisions in the 2007 FDA Amendments Act (FDAAA) that added greatly to FDA's oversight responsibilities for new drugs and biologics. Now, some legislators want to modify certain FDAAA requirements, particularly those for Risk Evaluation and Mitigation Strategies (REMs) and conflict-of- interest rules.

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