John Jenkins, MD, director of the FDA’s office of new drugs, offered several reasons for the lower number of approvals this year in a slide deck released Wednesday.
Here are Dr. Jenkins three reasons.
1. Some drugs that were meant to be approved in 2016 were approved before the end of 2015.
2. Fewer drugmakers filed new drug applications in 2016 compared to previous years. The FDA received 36 applications this year, compared to 40 in 2015.
3. The FDA filed more complete response letters, or rejection notifications, in 2016. The letters notify drugmakers that their drug cannot be approved in its current state. Companies can either withdraw the application, or file for approval again after addressing any concerns laid out by the agency.
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