FDA New Drug Approvals Soar in Early 2017

After FDA approvals slowed to their lowest rate in almost a decade in 2016, an increased number of approvals in early 2017 suggest that the Agency is on track to bounce back to the high levels seen in 2014 and 2015.

The FDA has approved 14 new drugs already in 2017, putting the Agency on track to outpace 2016’s 22 approvals for the entire calendar year.

This trend is in line with what industry experts have been expecting. In March, at the AMCP 2017 Annual Meeting, Aimee Tharaldson, PharmD, Senior Clinical Consultant in the Emerging Therapeutics department at Express Scripts, said during a presentation that approvals are expected to return to pre-2016 levels.

“In 2017 we are going to rebound,” she said. “There are 30 specialty drugs pending approval right now at the FDA—so we are going to see this come back.”

It appears FDA approvals are on the track to a comeback, with only 21 drug applications left in the 2017 FDA approval pipeline.

Reports indicate that the FDA is unlikely to approve more than 30 new drugs or biologics in the 2017 calendar year.

Furthermore, incoming FDA Commissioner Scott Gottlieb, MD, is expected to further spur FDA approvals. At the PBMI Drug Benefit Conference in March, Dr Gottlieb expressed support for expediting FDA approvals in order to bring new and generic drugs to the market faster. —David Costill