Report on Status of Regulatory Science at FDA
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Pharm Med 2009; 23 (1): 1-2 1178-2595/09/0001-0001/$49.95/0
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Report on Status of Regulatory Science at FDA Progress, Plans and Challenges Anthony W. Fox Consulting Editor, Pharmaceutical Medicine
Frank Torti, MA, MD, MPH, was appointed as the US Food and Drug Administration (FDA)’s first Chief Scientist and Principal Deputy Commissioner on 15 May 2008. Formerly, Dr Torti was an academic oncologist and epidemiologist, most recently as Professor of Medicine and Chair of the Department of Cancer Biology at Wake Forest Medical School. His earlier career was spent at Harvard and Stanford. Dr Torti’s report, with the same title as this Editorial, was issued at the end of February 2009.[1] It clearly builds upon two reports that emanated prior to his appointment.[2-4] Presuming that this report is intended to be taken seriously, some close review and comment upon it may be justified. Dr Torti builds his mission on five principles, none of which would be questioned by anybody wishing progressive change at FDA: 1. FDA must develop an overarching scientific strategy with an accompanying implementation plan, deliverables, timetables and budget; 2. FDA scientific strategy must be pre-emptive; 3. FDA must maintain and enhance its infrastructure, core expertise and human capital; 4. FDA must tell its story; 5. FDA cannot do it alone. It would be wrong to hold these five principles to the standards of other types of organizations. While the first four might be found in a typical research university or pharmaceutical company, the last (‘‘FDA cannot do it alone’’) distinguishes the special mission of a regulatory organization, and indeed represents a desirable situation (pace those who are deluded in thinking that the Agency conspires with its stakeholders). By analogy, judges often have the warring barristers before them do much of the legal research on points of law, without ceding any judicial ground. Evidently in consultation across the various centres within FDA, a variety of priority projects are then identified in the report and are sorted against these five principles. Here, the report is somewhat ‘retro’ and repetitive of what we have all
known for a few years already: for example, overarching scientific priorities include rapid detection of pharmacovigilance signals, development of biomarkers, more efficient clinical designs and analyses, etc. Microbial contamination (a highvisibility issue for both foods and drugs in the US at the moment) appears more than once. An original idea is that an ‘omics’ czar is proposed, to deal with genomic, proteomic and metabolomic issues across centres and reviewing divisions. This could well be seminal for the development of personalized medicine and is consonant with an FDA Science Board emphasis on differential drug response between racial groups. Combination product coordination also receives attention. However, its guru will only be an FDA fellow (essentially a 2-year post-graduate internship within the Agency). Outside interact
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