byÂ Susan F. Wood, PhDÂ
It’s not often, if ever, that an FDA sponsored report calls out for more resources, more direct action and organizational change for FDA.Â The recently released report (PDF) by the Subcommittee on Science and Technology for the FDA Science Board does just that.Â Although I wouldn’t necessary agree with all of the recommendations, and would call out for a few more, the report identifies some of the real needs at FDA for strengthened science.Â The FDA Science Board, an Advisory Committee to the FDA, has issued earlier reports, but none with the timeliness and potential impactÂ of this one.Â Most of the press coverage has been on the call for expanded resources – which are truly needed – but the report also identifies some of the scientific infrastructure needs that trail behind our expectations of this critical public health agency.Â I don’t know if FDA expected this type of report, but hopefully it can be useful as a way to move the agency forward.
From the report:
the Subcommitteeâs 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 throughout the product life cycle, today and during the next decade.
Later it states:
Although this Subcommittee was asked to review gaps in scientific expertise and technology and not to assess available 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.
Findings and recommendations throughout this report identify issues ranging from adequate recruitment and retention of scientific staff to theÂ need for better risk assessment and modeling, and food safety concerns.
One of the key issues it identifies is the serious Information Technology needs.
The Subcommittee found that the FDAâs current critical information supply chains are, at best, inefficient, cost intensive and prone to promote errors in regulatory science due to the inability to access, integrate and analyze data. Incredibly, critical data resides in large warehouses sequestered in piles and piles of paper documents. There are no effective mechanisms to protect these paper records, which include very valuable clinical trial data.
The report also makes recommendations about the scientific organzition at the Agency with the finding that ” The FDA science agenda lacks a coherent structure and vision, as well as effective coordination and prioritization”.Â It recommends that FDA institute a new scientific organization.Â The report reiterates the recommendation from the IOM Drug Safety report, and one that is now required under the new FDA Amendments Act of 2007, calling for a Chief Scientific Officer to report to a Deputy Commissioner for Scientific and Medical Affairs.Â But it starts its recommendations on this topic with the following:
The centralization required is not simply one that comes from a senior person being on point. What is needed is a broadly empowered leader exclusively charged with managing and advocating for the science program. Also needed is a nimble infrastructure that can efficiently support central management aligned with Agency priorities and enabled by cross-Center engagement.
The Subcommittee recommends in the strongest way, the creation of such a central science infrastructure for developing, implementing and ensuring the execution of an effective science program. The following recommendations are critical: strengthen the role of the Deputy Commissioner/Chief Medical Officer.
It goes on to say:
This individual should be provided with sufficient budget to:
ô¹ Support program development, implementation and oversight
ô¹ Have the authority to develop, implement and oversee all science activities at the Agency, including budgetary authority
ô¹ Co-ordinate the science activities of individual centers with Agency-wide programs and goals
ô¹ Ensure the adequacy of science expertise across the Agency through effective recruitment, retention, ongoing professional development, and external partnering and collaboration
Funding for this type of authority is critical in order to have real impact, as is true for all of the recommendations made by this report.
Their final recommendation is a key one and notes the lack of followup on earlier reports – and as always to “follow the money”:
There is a long history of excellent reviews of the FDA that have been followed by little to no action taken to achieve the recommendations. Our final recommendation is based in our belief that effective resolution of the issues outlined in this report is urgent. In contrast to previous reports that have issued many of the same warnings, there are now sufficient data proving that failure to act in the past has jeopardized the publicâs health. We, therefore, urge the FDA to develop a comprehensive plan that includes how and when the Agency will respond to these recommendations, and to report that plan to the Science Board. We also recommend that this plan be aligned with the 2009 budget process in order to align the resources with the proposed response.
Susan F. Wood, PhDÂ is Research Professor at George Washington University School of Public Health and Health Services, where she is part of the Project on Scientific Knowledge and Public Policy (SKAPP).Â She also served as Director of the FDA Office of Womenâs Health from 2000-2005