The jury is still out on whether the FDA increased drug approval rate in 2011 represents the start of a more positive trend or is just a one year hiccup. By November the FDA had 35 approvals to claim--with 24 coming ahead of OKs in other countries. The agency publicly noted that 2011's approval rate will go down as one of the best years in the past decade after years of anemic approval rates.
True, but will it be sustained?
Most industry execs aren't ready to cheer just yet. The industry is still struggling with a poor productivity rate over the past decade, and is undergoing an unfinished revolution on the development front. Next year, we could see a drop in approvals. And if that happens, the FDA will be under even more pressure to work more closely with developers to better turn the odds in their favor. See Fierce Biotech.
Posted by Bruce Lehr Dec 26th 2011.