CDRH is not equipped to understand the science behind many cutting-edge device technologies, says a Nov. 29 report from the Subcommittee on Science and Technology, an ad hoc panel of the FDA Science Board.

The center needs more resources and personnel to improve its scientific understanding of wireless devices, nanotechnology, robotics and many other new technologies, the report says.

The ¹ report, which examines scientific know-how throughout the agency, was requested a year ago by FDA Commissioner Andrew von Eschenbach. He asked the Science Board, an independent body that advises the commissioner, to examine the scientific capacities FDA needs to support its regulatory functions.

The report, "FDA Science and Mission at Risk," concludes bluntly that science at FDA "is in a precarious position," with the agency "not positioned to meet current or emerging regulatory responsibilities."

In terms of both personnel and money, FDA "is barely hanging on by its fingertips," subcommittee member Peter Barton Hutt adds in an appendix. Hutt is a senior counsel at the Washington law firm Covington & Burling and a former FDA chief counsel.

Hutt notes: "The accumulating unfunded statutory responsibilities imposed on FDA, 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 - coupled with chronic underfunding by Congress - have conspired to place demands upon the scientific base of the agency that far exceed its capacity to respond."

New Technologies May Not Reach Full Potential

The report notes that while CDRH understands well that device technologies are rapidly evolving, it needs to expand its capacity to research and understand these technologies.

It recommends that CDRH "drill down" and set research priorities in 15 new technology areas, including aging-related devices, artificial organs, computerized devices and intelligent systems, early diagnosis/detection technologies, genomics and proteomics, home- and self-care devices, imaging systems, minimally invasive technologies, miniaturization technologies, photonic technologies, portable and mobile devices, robotic devices, sensor technologies, telemedicine, and wireless devices.

Without more personnel to support science needs in the premarket review of these emerging technologies, the report notes, the technologies "may be hampered, or not reach their full potential."

The report also recommends that CDRH try to provide forecasts of upcoming technologies every three to five years, instead of the current 10-year forecasts.

In addition, the device center should bring on 45 post-doctoral fellows, 25 undergraduate and graduate students, and more staff scientists to support research activities within its Office of Science and Engineering Laboratories.

At the same time, CDRH needs to provide more professional development opportunities for its scientists, including funding for staff to join scientific organizations and attend two scientific meetings a year, the report recommends.

At a Dec. 3 meeting in Gaithersburg, Md., the FDA Science Board accepted the report's recommendations and said it will push to have the report posted on the Web for public comment.

FDA Approps Bills Give Some Additional Funds

Although the panel that prepared the report was asked to assess only the gaps in scientific expertise and not FDA funding, it found it difficult to separate the two. "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," the report states.

The appendix by subcommittee member Hutt recommends that Congress commit to a two-year appropriations program to increase FDA employees by 50% and to double FDA funding. "Without these resources the agency is powerless to improve its performance, will fall only further behind, and will be unable to meet either the mandates of Congress or the expectations of the American public," Hutt writes.

But it is almost certainly too late for such a large budget increase for the agency in fiscal year 2008. In July, the House and Senate appropriations committees cleared FDA fiscal 2008 funding bills totaling $1.69 billion and $1.76 billion, respectively - only 8%-12% above the fiscal 2007 appropriated level. The House version was passed by the full chamber Aug. 2.

Rep. Rosa DeLauro, D-Conn., chair of the House appropriations subcommittee that oversees FDA funding, told "The Gray Sheet" that the new report "confirms what everyone within Congress, and at the FDA for that matter, has known for a long time - the science at FDA is deteriorating and the agency lacks the planning, management structure and resources to restore their scientific capabilities."

A spokeswoman for DeLauro wondered why, if FDA needed the additional funds, it did not request them through the traditional budget process back in February. "If they needed additional funds, that's the process they should have used," spokeswoman Adriana Surfas said.

Under the House-passed bill (H.R. 3161, the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008), FDA would get an additional $128 million over its FY 2007 funding amount, equivalent to $62 million above the Bush administration's fiscal 2008 request for the agency.

However, the funding measure is under a veto threat made July 31 by President Bush, who complained that the overall bill exceeds his funding request by nearly $1 billion.

"Unfortunately, Congress is being put in a position where it will be forced to cut funding for many agencies, including the FDA, if the administration follows through with its veto threat," DeLauro said.

"However," she added, "money alone will not resolve the problems at FDA - these additional funds need to be supported by an adequate management structure and a sound plan on how these funds will be used to ensure that they are not wasted.

"Congress cannot be in the business of providing unconditional blank checks to agencies like the FDA that disregard scientific integrity in favor of corporate and political considerations," she concludes.

- Sue Darcey (s.darcey@elsevier.com)

FDA Scientific Capacity Inadequate; New Device Technology At Risk

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