Proactive communications and breaking the impasse with FDA

Communicating early and proactively with FDA appears to improve the likelihood of an earlier approval for a new drug or biologic. Last Friday, FDA released a report commissioned by Booz, Allen Hamilton which shows that:
  • 52% of companies that met with FDA at the end of Phase 2 trials received approval during the first review cycle vs. 29% for companies that did not meet with FDA during this period.
  • Of 58 new drug products for which manufacturers met with FDA before even submitting the application, nearly half received approval during the first cycle.
These early meetings did not always eliminate the need for multiple review cycles. In fact, in 71% of the applications where FDA identified problems during presubmission meetings, manufacturers failed to address the issues by the time of first action. Nevertheless, it appears that early and proactive communication works well. The Agency has seen a 60% increase in requests for consultations, which exceeded 2,400 last year. For more information on the study and to order a copy, click here. -AMS