Predictive Medicine Means "Ten Years of Bad News"
This article was originally published in RPM Report
FDA expects pharmacogenomics to help turn around drug development. But one researcher says the first decade of applying the tenchonology will focus almost exclusively on limiting markets.
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The drug approval drought keeps getting worse. FDA says it approved 20 new products during the year, one of the lowest totals in two decades. In fact, focusing on genuinely innovative medicines, the total was even worse. The good news is that 2006 should be a much better year. But focusing on 2006 misses the point: it's the long-term trend that matters. The hope for a turnaround relies on some leaps of faith. Industry is gambling that advances in drug development science will pay off-even though the first efforts to reap the fruits of the genomics revolution are one reason for the current drought.
Final phase overhaul of FDA's new drug review groups includes half-a-dozen first-time division directors. Most have long experience at the agency – but not all with the drugs they will now oversee.
If the President says over and over again that a drug is approved, does that make it so?