There are plenty of uncertainties ahead in 2008. The FDA, for all of its happy talk about speeding discovery times and collaborating on new techniques, has demonstrated a growing, bureaucratic aversion to risk. There's a cyclic reaction going on that appears to be raising the bar for some developers.
As a nation, the U.S. seems to find it hard to grapple with the simple fact that every drug--barring Tylenol--has significant risks associated with it. No new compound will hit the market without leaving a trail of some damage. And the benefits won't always seem to outweigh the risks.
A frank discussion about risks and benefits--including physicians who have prescribed drugs with a far too lackadaisical attitude--is long overdue. Instead, we're likely to continue to be treated to more marketing talk from drug companies for each new product, which in turn will inspire more regulatory skepticism. Unrestrained marketing and careful risk/benefit analysis don't mix, and it's having an ill effect on drug discovery.
The agency is likely to continue to send mixed messages to developers, who will be left picking through every agency decision for clues on how to proceed. Some clarity is badly needed.