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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
The scientific demands on the US Food and Drug Administration far exceed its capacity to respond, according to a recent report by the Subcommittee on Science and Technology of the FDA Science Board.
Washington DC (Dec. 3)-The scientific demands on the US Food and Drug Administration far exceed its capacity to respond, according to a recent report by the Subcommittee on Science and Technology of the FDA Science Board.
In December 2006, FDA Commissioner Andrew von Eschenbach requested that the Science Board, which is the advisory board to the commissioner, form a subcommittee to assess whether science and technology at the FDA can support current and future regulatory needs. Specifically, the subcommittee’s charge was to identify the broad categories of scientific and technologic capacities that FDA needs to fully support its core regulatory functions and decision making.
“The Subcommittee concluded that science at the FDA is in a precarious position: the Agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities,” says the report.
The subcommittee found that the deficiency stems from two sources: increased demands on FDA that “have soared due to the extraordinary advance of scientific discoveries, the complexity of the new products and claims submitted to FDA for premarket review and approval, the emergence of challenging safety problems, and the globalization of the industries that FDA regulates” and that “resources have not increased in proportion to the demands. The result is that the scientific demands on the Agency far exceed its capacity to respond.”
The subcommittee found substantial weaknesses across the Agency, with the possible exception of some drug and medical device review functions funded by industry user fees. The significant findings from the report are outlined below.
• FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak. The Subcommittee identified eight emerging science and technologies that are most challenging FDA: systems biology (including genomics and other “omics”), wireless healthcare devices, nanotechnology, medical imaging, robotics, cell- and tissue-based products, regenerative medicine, and combination products.
The report also said that FDA cannot fulfill its surveillance mission because of inadequate staff and information technology (IT) resources to implement cutting-edge approaches to modeling, risk assessment, and data analysis. The report also says that FDA lacks a coherent scientific structure and vision as a result of weak organizational infrastructure. “Consistent and rigorous peer reviews of programs and processes, which are currently lacking, are critical for wise utilization of resources and for rebuilding the Agency’s ability to implement its science-based regulatory responsibilities effectively,” says the report.
• The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability. The subcommittee found that despite the significant increase in workload during the past two decades, in 2007, the number of appropriated personnel in FDA remained essentially the same - resulting in major gaps of scientific expertise in key areas. The reports says FDA faces substantial recruitment and retention challenges, citing that the turnover rate in FDA science staff in key scientific areas is twice that of other government agencies. The subcommittee also says FDA has insufficient programs for measuring worker performance and professional development and for collaboration with external scientists.
• FDA cannot fulfill its mission because its information technology (IT) infrastructure is inadequate. The subcommittee was “extremely disturbed at the state of the FDA IT infrastructure,” citing that FDA has insufficient access to data and cannot effectively regulate products based on new science because of a lack of a supportive IT infrastructure. The subcommittee noted that the FDA IT infrastructure is obsolete, unstable, and lacks controls to execute effective disaster recovery protocols that ensure continuity of operations when systems are compromised and that its IT workforce is insufficient.
Recommendations by the subcommittee
The subcommittee emphasized the need for more funding for FDA to address these deficiencies and offered specific suggestions for improvement These include creating a cross-agency approach for a governance structure to provide a forum for the “new sciences,” forming working groups to evaluate these approaches, and establishing ongoing extramural collaborations with other agencies, academia, and industry.
The report further recommends establishing a new entity, the Incubator for Innovation in Regulatory and Information Science (IIRIS), which would be under the direction of a newly created position of chief scientific officer. The role of IIRIS would be to recruit cross-disciplinary scientists to serve as liaisons with groups across the agency involved in the “new science” programs. The IIRIS team would not do the scientific work, but rather would be the project managers to nurture and track program progress. IIRIS would also be responsible for the creation of the proper computation, technical and biological infrastructures (e.g., measurement, visualization and computational facilities), and work to create strategic partnerships with academia, industry and governmental laboratories.
In addition to establishing the position of chief scientific officer, the subcommittee recommends other organizational changes. These suggestions include:
• Strengthening the role of the deputy commissioner/chief medical officer, which would involve renaming the position to deputy commissioner of medical and scientific affairs, to be responsible for all scientific aspects of FDA, and ideally to have this position broken into two separate positions
• Creating the positions of deputy directors for science that would have dual reporting responsibilities to the center director and the chief scientific officer.
• Creating a new position of director of extramural collaborations and training that would report to the deputy commissioner and chief scientific officer
• Creating a board of external scientific counselors for each center within FDA.