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Playing Catch-Up: The FDA, Science, and Drug Regulation
Calfee attributes the recent slow-down in medicines generated by the biopharmaceutical industry that reach eventual FDA approval as the result of conflicting trends in science and regulation. On the one hand, advances in basic science are producing new therapeutic drug candidates that attack new disease targets and may require new models for testing their efficacy and safety. On the other hand, powerful political forces that lead the agency to value caution over innovation continually buffet the FDA.
The central issues today lie not in financial resources but in the difficulty of exploiting DNA-based and other biotechnology-generated applications of new science. The new methods encompass essentially the entire range of activities in drug development, starting with novel biological mechanisms (such as therapeutic vaccines that harness the immune system to treat diseases like cancer instead of preventing them) and continuing through toxicity testing (animals and humans), diagnostics, the design and interpretation of clinical trials, dosing, administration, and safety monitoring before and after FDA approval (Usdin 2005; FDA 2004b).
Calfee is, in the end, cautiously optimistic that the agency is capable of adapting to the challenges facing it. Much depends, however, "on the energy and persistence of current leadership and, far more important, the extent to which the FDA revises the incentives facing its own staff and the pharmaceutical industry."
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