FDA Commissioner von Eschenbach requested a hard look at the FDA one year ago, and this report is the sobering culmination of that effort. The Subcommittee included leading members of the scientific community familiar with emerging science, the external marketplace, and the Agency’s operations.
The conclusions are clear and severe: the FDA plays a central role in the health, safety and security of the US, as well as providing global thought leadership. But the 3 pillars of the FDA’s own health are crumbling.
Those 3 pillars, as the report calls the linchpins of a healthy FDA, are:
1. A strong scientific research base, and relationships with outside scientists and innovators
2. Outstanding internal staff with “cutting-edge expertise”
3. An information technology infrastructure and processing capability that supports the FDA’s mission.
These weaknesses put the nation’s food supply, public health, and security (e.g., anthrax and bioterrorism) at-risk.
Also at-risk are health innovations — especially the new world of ‘omics.’ The report points out that the FDA lacks significant expertise in eight key emerging areas of science: systems biology (genomics and other omics), wireless healthcare devices, nanotechnology, medical imaging, robotics, cell and tissue-based products, regenerative medicine, and combination products (think: two-in-one drugs, or diagnostic devices married to therapies).
A further liability on the staffing side is that the turnover rate among FDA’s science staff is twice that of other government agencies. Some of the brightest lights at FDA leave for the private sector quite quickly; this brain drain is a substantial loss to the Agency’s intellectual capital.
To bolster the 3 key pillars, the Subcommittee could not avoid talking about funding — although they were specifically asked not to assess the issue of FDA financing. However, the Subcommittee members found that resource issues are inextricably bound up with the decline and fall of the FDA.
The recommendation: double FDA funding, from 1.5 cents per American to 3 cents.