FDA Revamps to Meet New Challenges - Pharmaceutical Technology

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FDA Revamps to Meet New Challenges
Added responsibilities and outside concerns prompt overhaul of agency's structure.

Pharmaceutical Technology
pp. 22-26

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.

Spielberg up front

The challenge for Spielberg, a leading pediatrician and pharmacologist, is to coordinate responses to these issues. His elevated position makes him a ready spokesman for FDA medical-product regulators and gives him authority to make timely policy decisions that otherwise would wait for Hamburg to weigh in. He also will facilitate the development of products that involve multiple agency centers, including combination products, orphan drugs, and pediatric therapies.

Spielberg comes to FDA with 30 years experience in academia and industry. He has served on FDA advisory committees and got to know Hamburg as a member of the advisory Science Board. Before coming to FDA, Spielberg was director of the Center for Personalized Medicine and Therapeutic Innovation at Children's Mercy Hospital in Kansas City, Missouri. Previously, he was dean of Dartmouth Medical School, and prior to that, he held senior research positions at Johnson & Johnson and Merck. While in industry, he chaired a Pharmaceutical Research and Manufacturers of America pediatric task force and was instrumental in promoting the Best Pharmaceuticals for Children Act, which was enacted in 2002 to provide incentives for developing pediatric therapies.

An initial task for Spielberg is to orchestrate reauthorization of the Prescription Drug User Fee Act (PDUFA), along with new fees for generic drugs and biosimilars, by September 2012. Although industry and FDA generally agree on a new five-year PDUFA program, they fear that the legislators will add numerous pet policies to this must-pass legislation.

A related challenge for Spielberg is to help resolve serious disagreements between the medical-device industry and the Center for Devices and Radiological Health (CDRH) over proposals to revise the device-approval process. Safety issues and notable product recalls have prompted efforts to stiffen FDA regulatory and testing requirements, particularly for those products approved under the 510k regulatory procedure. After a lengthy evaluation process, which included public meetings and an IOM report, CDRH officials have proposed changes likely to require additional clinical testing of some devices. Manufacturers are protesting vehemently and urging Congress to support innovation by blocking such action.


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