FDA new drug approvals sink to six year low

pharmafile | December 21, 2016 | News story | Medical Communications, Research and Development FDA, NDA, new drug approvals 

The FDA has released figures to show that drug approvals have fallen from last year’s high of 45 new drugs approved to this year’s figure of 19. The recently passed 21st Century Cures Act should see new drug approvals speed up but it’s a worry for the FDA when President-elect Trump has already made pointed comments about increasing access to drugs at a faster rate.

The reasons provided by the FDA’s director of the office of new drugs, Dr John Jenkins, were broken down into three points:

  • 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.

The first point is enough to skew figures slightly, with five new drugs approved in 2015 when they were expected to pass into 2016. This artificially inflated figures for the previous year and took away some of the numbers from this year.

Image: FDA

This will perhaps not be enough to ease worry that investment into R&D does not bring the returns to pharmaceutical companies that it once did, with returns on investment sitting at 3.7% this year. When this is combined with the increasing pressure being placed upon drug pricing, with the recent Mylan scandal and suggestions of price collusion between companies, things begin to look slightly troubling for continuing to make similar levels of profits through R&D.

Ben Hargreaves

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