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Monday, February 28, 2005 1:02:09 AM
"In short, the FDA is creating a pathway to personalized medicine that will bring the right drug to the right person at the right time. Since the associated factors that make a particular drug or treatment work at a genetic level won't be detected by large clinical trials, the FDA can require companies to see how drugs work in the real world, instead of the artificially controlled environment that drug studies use.
Drug and biotech companies are already responding to Critical Path. More drugs, specifically cancer medicines, are being developed to target smaller populations.
The benefits of this approach are many. An IBM study called Pharma 2010 estimates that the Critical Path approach will cut drug development times from 15 years to five, saving nearly $500 billion in drug development costs.
Also, eliminating side effects and unnecessary care — from taking the wrong drug — could save the health care system and consumers up to $100 billion a year, according to a report by the Cambridge Health Institute.
As such, Crawford should reject calls to add more clinical trials and bureaucracy to the FDA. Critical Path reform is not a panacea, but it can make drugs safer while harvesting the fruits of gene-based research."
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