Top Ten Health Law Stories in 2008: FDA

There's no denying either the urgency of the FDA's mess or the bipartisan political appeal of the issue of food and drug safety. Consider this lead from the New York Times' Nov. 29 article on the latest report describing the agency's woes:

The nation’s food supply is at risk, its drugs are potentially dangerous and its citizens’ lives are at stake because the Food and Drug Administration is desperately short of money and poorly organized, according to an alarming report by agency advisers.

The report can be found here. (If the lack of an easily navigable website is any indication of agency disorganization, the FDA must be the poster child for agency chaos. This report is almost impossible to find using any of the links on the website. Then again, considering the devastating critique contained in the report, maybe the powers-that-be are trying to make it hard to find.)

Here are some of the major findings:

• The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.
  
• FDA does not have the capacity to ensure the safety of food for the nation.
• The development of medical products based on “new science” cannot be adequately regulated by the FDA.
• There is insufficient capacity in modeling, risk assessment and analysis.
• FDA science agenda lacks a coherent structure and vision, as well as effective coordination and prioritization.


• The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability.
• The FDA has substantial recruitment and retention challenges.
• The FDA has an inadequate and ineffective program for scientist performance.
• The FDA has inadequate funding for professional development.
• The FDA has not taken sufficient advantage of external and internal collaborations.


• The FDA cannot fulfill its mission because its information technology (IT) infrastructure is inadequate.
• The Subcommittee believes that there is evidence of important, but slow, progress to improve information sciences and technology at the FDA over the past few years, yet significant gaps remain.
• The FDA lacks the information science capability and information infrastructure to fulfill its regulatory mandate.
• The FDA cannot provide the information infrastructure support to regulate products based on new science.
• The FDA IT infrastructure is obsolete, unstable, and lacks sufficient controls to ensure continuity of operations or to provide effective disaster recovery services.
• The IT workforce is insufficient and suboptimally organized.

If that's not enough to make your Post Toasties wilt, I don't what is . . . .