The FDA's Janet Woodcock, Director CDER, testified before Congress that the number of new chemical and molecular entity approvals had reached a 20-year high to date in 2011. Twenty drugs have been approved in 2011 so far as compared to 21 drug for all of 2010.
Woodcock further pointed out that the low number of approvals was more a function of attrition in the pharma pipelines than due to regulatory rulings by the FDA. A recently issued report states that drugs moving to phase III dropped by 55% in 2010, with comparable decreases of 50% and 47% for phase II and phase I respectively. Thus, the number of drugs reaching a submission for approval is down and therefore the number of approvals would be expected to follow. See Fierce Biotech.
Posted by Bruce Lehr July 8th 2011.