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Peter Wetherall
Peter Wetherall
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FDA's Pursuit of Drug Safety an Underfunded Farce

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http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_00_index.html
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_00_index.html
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_00_index.html

According to an FDA Report on Science and Technology published on December 3, 2007, the FDA is essentially not able to fulfill its mandate of assuring the safety of drugs. This isn’t the “greedy” plaintiffs’ lawyers talking – it’s an internal self-assessment by the FDA itself.

The Report contains these major findings of the subcommittee:

1.2.1 The FDA cannot fulfill its mission because its scientific base
has eroded and its scientific organizational structure is weak.
1.2.2 The FDA cannot fulfill its mission because its scientific
workforce does not have sufficient capacity and capability.
1.2.3 The FDA cannot fulfill its mission because its information
technology (IT) infrastructure is inadequate.

The Report goes on to include in its Summary Statement:

In contrast to previous reviews that warned crises would arise if
funding issues were not addressed, recent events and our findings
indicate that some of those crises are now realities and American lives
are at risk.

I suppose this dire appraisal could just be a cry for help of a type politicians and bureaucrats use to justify more funding, but even by political standards, this Report is scary. Clearly, all is not well at the FDA, and to the extent anyone out there still clings to the notion that we’re being meaningfully protected from many drug companies’ reckless quest for profits, this Report should shatter that illusion.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.