Sharp slowdown in US FDA new drug approvals in 2016

The US Food and Drug Administration approved a total of 22 new chemical entities during 2016, a disappointing six-year low. This was well down on the 45 that the FDA cleared for marketing in record year 2015, and 41 in 2014.

The slowdown suggests the pharmaceuticals industry may be returning to more normal productivity levels after a spike in approvals in 2014 and 2015, when the haul of new drugs reaching the market hit a 19-year high, noted a Reuters report.

Several factors led to the fall in the approval rate in 2016, John Jenkins, the FDA's director of the Office of New Drugs, told a conference last month. Notably, five new drugs that had been scheduled for approval in 2016 ended up winning an early clearance at the end of 2015. There was also a decline in drugs being filed for approval and the FDA rejected or delayed more applications in 2016 than in the previous two years.