Drug approvals in 2016 were down sharply from the year before and were the lowest in six years.
The Food and Drug Administration gave the nod to just 22 new medications, after approving 45 new drugs in 2015. Approvals were at their lowest since 2010.
FDA officials say approvals fell because of several factors, including a half dozen drugs that were originally scheduled for approval in early 2016 but got the go-ahead at the end of 2015. In addition, fewer drugmakers filed products for approval and the FDA rejected or delayed more applications than in previous years.
The slowdown in approvals is also pronounced since approvals spiked in 2014 and 2015, when the influx of new drugs hit a 19-year high.
Congress passed a healthcare bill at the end of last year that aims to speed up new drug approvals and make the functions of the FDA more efficient and effective. But the measure was softened to get bipartisan approval, and watchers say it won’t prompt any major overhauls in the process of getting a drug approved.
Overlaying the issue is heavy political pressure to bring down high drug prices, a problem that has sparked public outrage over the last few years. President-elect Trump has promised he will take action to mitigate soaring drug costs.
