NEW YORK (GenomeWeb News) – The US Food and Drug Administration is largely unprepared to keep up with the advances in biomedical sciences in general, and genomics and pharmacogenomics in particular, a new FDA Science Board subcommittee report soberly warns.
Two decades of “soaring demands” on the FDA caused by the brisk march of medical science “far exceed” the resources and funding provided by the federal government, leaving the agency charged with minding the public’s welfare on such matters at risk of not being able to fulfill its responsibilities, states the report from the FDA’s Subcommittee on Science and Technology.
Senior FDA officials, analysts, and industry representatives went before the Subcommittee on Oversight and Investigations, which is part of the House Energy and Commerce Committee, this week to comment and provide testimony about how a paltry federal response to the shifting biomedical landscape has left the FDA weakened and “in a precarious position,” according to the report.
“The need to improve science at FDA is not in question,” FDA Commissioner Andrew von Eschenbach said in written testimony he gave to the committee. “The hard question we must now answer is how to prioritize the investments needed in the Agency’s regulatory science infrastructure.”
“FDA can’t improve its science, prepare for the future, or protect American consumers without significant additional resources,” former FDA Commissioner Don Kennedy said in a statement issued by an advocacy group called the Alliance for a Stronger FDA.
Kennedy also pointed to politicking that may be expected in the coming months over the federal government’s fiscal year 2009 budget, saying that the “Administration and Congress are starting now on the FDA’s FY 2009 budget and must fix this critical problem.”
The 2008 budget for the Department of Health and Human Services, under which the FDA operates, caused much friction between Congress and the White House, and resulted in stalled funding levels across the government, a presidential veto, and a chiding by President Bush about congressional earmarks.
Urging Genomics Resources
After ticking off a litany of deficiencies that leave the FDA too eroded to tackle the issues it expects to confront, the report also posits a number of problems it faces in the genomics field, and proposes direct measures to deal with them. Those actions include creating a formal Genomics Program, because the “continued absence of an organized structure may lead to difficulties in staff recruitment and retention,” according to the report.
In addition, it recommends up to 80 full-time experts dedicated to monitoring safety in areas such as preclinical technology, clinical stratification, biomarker evaluation, post-clinical technology, and food safety.
The FDA also should establish a genomics core laboratory at the White Oak research lab in Maryland, the subcommittee recommended. This lab could be staffed with some of the 80 full-time experts and support staff who have expertise in expression profiling, sequencing, informatics, proteomics, metabolomics, and systems biology.
The agency will need to expand its bioinformatics infrastructure in order to support this FDA core lab, the report advised. This expansion would entail the development of data storage, mining, analysis, and risk-evaluation tools to handle data generated by the ever-advancing capabilities of high-throughput technologies.
While around 60 full-time and part-time employees across the FDA are involved in genomics, the report said it must also recruit, train, and retain more scientific staff that are versed in bioinformatics and who can deal with the loads of information that comes from genomic analysis.
More collaboration with academic centers and the private sector will be needed to keep up with “the rapid evolution of genomics technologies and statistical methods.” The subcommittee figured that collaborative agreements with as many as ten new non-federal entities may be necessary to satisfy this need.
Unable to Fulfill Its Mission
Although there has been open discussion over the past year about the FDA’s flagging capabilities, notably in the areas of drug oversight and foreign inspections, this subcommittee report sketches the agency’s fall from form in starkly phrased bullets.
“The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak,” the subcommittee claims, and “cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability.”
The subcommittee also said that FDA cannot fulfill its mission “because its information technology infrastructure is inadequate.”
The report also concludes that, although it was tasked with reviewing gaps in science and technology and not assessing resources, “it rapidly became apparent that the gaps were so intertwined with two decades of inadequate funding that it was impossible to assess technology without also assessing resources.”
Along with its analysis of the current state of the agency, the subcommittee analyzed the work and comments of past review panels which, “particularly over the past two decades,” the group said, had issued disturbing assessments about the FDA’s expanding responsibilities and declining resources.
The subcommittee, however, believes that this review is different. “In contrast to previous reviews that warned crises would arise if funding issues were not addressed, recent events in our findings indicate that some of those crises are now realities and American lives are at risk,” the report warns.
The stark language in the report, which stresses the potential risk of life and death and tethers that risk directly to what it considers slumping funding compared with the FDA’s demand and responsibilities, comes just before the White House prepares its 2009 federal budget request.
Between fiscal years 2003 and 2008, FDA appropriations have risen from $1.37 billion to $1.73 billion, with this year’s increase from 2007’s budget of $1.57 billion being the largest of the period.
Although the FDA will not receive this year the roughly $2.1 billion it requested, it is “very fortunate” it was authorized as much as $76 million more than the White House had sought for it and a total 13 percent rise over 2007, FDA Deputy Commissioner for Operations and COO John Dyer commented recently in a report to agency employees.
The rise in funding “reverses the pre-FY 2007 trend of not keeping up with cost of living increases, and puts FDA on a path forward” to meet its responsibilities and goals, Dyer said, and to hire over 750 new employees this year in addition to replacing approximately 730 staff members who are expected to leave due to normal turnover.