CDER New Drug Review Update 2015

FDA released a presentation by John Jenkins, M.D., Director, Office of New Drugs at CDER.  The report is rather astounding and signals that the PDUFA program and the way FDA approached drug approval is not only collaborative but also thorough.  One rather amazing piece of information is the first action approval rates for FY 2015.  The overall first action approval rate for NDAs and BLA was reported at 95% with Priority Review NDA/BLA applications at 93% and Standard NDA/BLA first action approvals at 100%.  That is some incredible work.

This begs the question- is FDA just rubberstamping NDA/BLA approvals?  No, says Dr. Jenkins, and, in providing reasons why the first action approval rates are so high, he notes:

  • CDER has not changed its interpretation of the statutory standard for approval – we are not a “rubber stamp”
  • Factors that may be contributing FDA guidance/meetings during IND to clarify expectations for development programs – improves quality of NDAs/BLAs
  • NME Program – complete applications at time of filing and more time for interactions with sponsor to address deficiencies
  • Targeted therapies – greater benefit/less risk in selected patients
  • More orphan drugs – alters benefit/risk balance
  • BT designation – “all-hands on deck” for sponsor and FDA
  • Focus of sponsors away from “me too” drugs and diseases with available treatment options with less favorable B/R balance
    • Not necessarily a good outcome from a public health perspective

Another interesting observation is that the US was the first to launch about 60% of new active substances in the world in 2014.

Median review times were up slightly, but due to the 60-day filing review, that is now counted outside of the PDUFA goal date and is off the clock.

The presentation is well worth spending some time reviewing as it contains a lot of useful and important facts and figures.  The presentation and can be accessed here.  Enjoy!