US drug approvals are on track to drop by more than half in 2016 compared to 2015, according to a December 14 presentation by the US Food and Drug Administration (FDA).
The agency had approved 19 new drugs this year as of December 9, putting it on track for its lowest yearly tally since 2007. The decline is made more dramatic by 2015’s bumper crop of approvals. The FDA approved 45 new drugs last year — the highest total in nearly 20 years.
John Jenkins, director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, attributed the decline to a reduction in submissions and to the speedy review of five drugs approved ahead of schedule in 2015. The agency also rejected more drugs, he noted: in 2016, 61% of the FDA’s decisions were approvals, compared to more than 95% in 2015.
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The data come as the agency waits to find out who will be its next commissioner under US president-elect Donald Trump. Trump has said that he wants to speed up drug approvals and cut through “the red tape at the FDA”. And on December 13, President Barack Obama signed into law the 21st Century Cures Act, which includes measures — some of them controversial — intended to streamline drug approvals.
This article is reproduced with permission and was first published on December 19, 2016.
