Late last week, I published an account from the FDA's Janet Woodcock touting the pace of first cycle bio drug approvals in 2011 -- which are at 20-yr high! Woodcock also pointed out that the agency meets more than 90% of the review deadlines that are set. Two-thirds of new drugs being approved are within 6 to 10 months following their applications.
Jonathan Leff, a managing director at WarburgPincus LLC (a VC firm), counters however that the FDA's tougher stance on safety since 2004 is a major contributor to rising drug costs and the length of drug development.
He says, "At a time when medical research is exploding with potential, many promising scientific discoveries are not being developed into new treatments for disease due to lack of investment capital." He went on to cite figures showing venture investment in the US life sciences industry declined by $2 billion from 2008 to 2010.
Posted by Bruce Lehr July 11th 2011.