FDA regulations are often blamed for the high cost of drug development, but drugmakers' business decisions may be the real culprits, writes Bernard Munos. FDA approval requires two successful Phase III trials, but drugmakers performed dozens of trials in support of blockbusters, whether to broaden the indication or in support of marketing, Munos writes. Moreover, the high failure rate of pre-approval Phase III trials seems to indicate that executives are pushing mediocre drug candidates through the pipeline, he writes.
FDA regs are not the only drivers of R&D costs
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