New US FDA drug approvals down to six-year low in 2016
03 January 2017
The US Food and Drug Administration (FDA) cleared only 22 new medicines for sale last year, the lowest number since 2010 and much down on 2015 tally of 45.
The European Medicines Agency, in the same period recommended 81 new prescription products against a 2015 total of 93. Unlike the FDA, the EMA's list includes generic drugs.
According to commentators, the slowdown suggested the pharmaceutical industry might be returning to more normal productivity levels following a surge in approvals in 2014 and 2015, when the haul of new drugs reaching the market hit a 19-year high.
The approval rate in 2016 had fallen dude to several factors, according to John Jenkins, the FDA's director of the office of new drugs, who spoke at a conference last month.
Five new drugs that had been scheduled for approval in 2016 had received an early green light at the end of 2015. There was also a decline in filing of drugs for approval and the FDA rejected or delayed more applications in 2016 than in the previous two years.
According to commentators, some of the delayed drugs might go on to win approval in 2017, including Roche's multiple sclerosis treatment Saor rheumatoid arthritis.
Meanwhile, Paige Winfield Cunningham, in a blog in The Washington Examiner pointed out that Congress passed a healthcare bill at the end of last year that aimed to speed up new drug approvals and make the functions of the FDA more efficient and effective. The measure was, however, watered down to win bipartisan approval, and according to observers, it would not prompt any major overhauls in the process of getting a drug approved.
There was also the heavy political pressure to rein in high drug prices, a problem that had sparked public outrage over the last few years, with president-elect Trump promising to take action to mitigate soaring drug costs.