There is no doubt that the number of FDA approvals for new chemical entities (NCEs) in 2016 will be lower than in the past two years. That isn’t a surprise. The 86 NCEs approved by the FDA over 2014/2015 is the second highest total in FDA history, surpassed only by the 92 approved in 1996/1997. In fact, one could argue that, given the much higher hurdles that now exist for getting drugs not just approved but also reimbursed, the 2014/2015 productivity is the best ever achieved by the industry.
