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Playing Catch-Up: The FDA, Science, and Drug Regulation
Joseph Calfee, Ph.D., American Enterprise Institute, 3-28-06

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).

Translating these methods into approvable treatments and diagnostics has proven time-consuming and financially risky even as new technology has begun to generate extraordinary therapeutic advances. Thus Scott Gottlieb, deputy FDA commissioner for medical and scientific affairs and a former senior fellow at AEI, recently observed, "The plain truth is that a lot of the new technologies we've developed over the last five years—proteomics, genomics, and microarrays—have only added to the cost of discovery and development without making the process any faster or more certain"...

It is only natural that such rapid advances in basic and applied science should pose challenges for the FDA. This is in contrast to incremental technological progress in drug development, which usually does not raise some of the most difficult issues in applied science, such as exploratory clinical trial endpoints, highly novel biological mechanisms, new manufacturing methods, and very different diagnostic tools.

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."

Project FDA.
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