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August 06, 2008


I agree with you assessment. However, I believe that this is only one part of the problem. The other part is that Big Pharma must alter its business model from being blockbuster-centric to adjusting to the personalized medicine trend. As tests are developed that will predict the individuals likely to respond to a specific treatment, the population for whom those treatments will be prescribed will decrease significantly. Big Pharma must adjust to this segmentation of their market if it hopes to survive and thrive.

Dear Michael:

I agree, but only insofar as the FDA adapts, too. For example, if an innovator determines that individuals with a certain phenotype should (or should not) be administered the drug, then safety and efficacy studies involving individuals outside these groups should not be required (although there would have to be a label warning to that effect). In that case, the costs of doing the clinical trials should be decreased, and the success rate of lead compounds should increase, and then (but only then) would there be an economic basis for pharma to eschew the "blockbuster" approach.

Until then, pharma's detractors need to recognize that much of what they don't like about pharma's business practices are the consequence of a system aimed towards minimizing harm to the public from FDA-approved drugs. The Bush administration has the wrong solution - use preemption as a way to prevent harmed individuals from suing in tort. (Of course, ultimately the taxpayers will pay the price for this system.) The right solution is to try to make the approval process more efficient, and your ideas need to be part of that.

Thanks for the comment.

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