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As far as drug approvals go, the FDA was on a roll in 2015.
That year, the FDA – the agency that’s responsible for making sure the medicine we put into our bodies is safe and effective – approved 45 new drugs.
In 2016, however, that tally’s only up to 19. That’s the fewest new approvals in a year since 2002.
The count includes only completely new molecular entities, or drugs that haven’t been approved in any other context.
The FDA’s director of the office of new drugs, Dr. John Jenkins wrote in a slide deck released Wednesday that the reason there were so few approvals in 2016 compared to 2015 had to do with a couple factors:
- First, some drugs that were meant to get approved in 2016 ended up getting approved by the end of 2015. Fewer new drugs filed for approval in 2016 compared to 2016. The FDA filed more complete response letters in 2016. These letters tell drugmakers that their drug won’t be approved the way it is now, and the companies can either withdraw their application or file again for approval once they’ve made changes and collected more information that the FDA’s looking for.
Here’s what approvals have looked like over the past 23 years.