PictureQuest
A plain tablet in a no-name blisterpack. It could save a life.
Or maybe not.
Since 1994, the Food and Drug Administration has approved year-to-year increases in the number of new candidate drugs for human testing in the United States, rising from 3,350 in 1996 to 3,900 in 2002.1 But the number of drugs that successfully negotiate the trial process and ultimately receive FDA approval is frustratingly low. Despite pharmaceutical companies' and the National Institutes of Health's research budgets doubling since 1993, the number of approvals for new drugs with a novel chemical structure fell from 53 in 1996 to 21 in 2003.
"Currently, a striking feature of this path [to market] is the difficulty, at any point, of predicting ultimate success with a novel candidate," states a recent FDA report.2
And herein lies a large part of the problem: While new technologies have lead to significant breakthroughs at ...
