FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization Timelines.

Area of Science:

• Drug regulatory affairs
• Pharmaceutical development
• Clinical trial acceleration

Background:

• The US Food and Drug Administration (FDA) offers four facilitated regulatory pathways (FRPs): Fast Track (FT), Breakthrough Therapy (BTD), Priority Review (PR), and Accelerated Approval (AA).
• Only Priority Review (PR) mandates an expedited review timeline of 6 months.
• The impact of combining multiple FRPs on drug development and approval durations remains incompletely understood.

Purpose of the Study:

• To investigate the extent to which combining two or more FDA facilitated regulatory pathways (FRPs) influences drug development and approval timelines.
• To compare the effectiveness of single FRPs versus combinations of FRPs in accelerating regulatory processes.

Main Methods:

• Analysis of 125 new active substances approved between January 2013 and December 2015.
• Assessment of 74 substances that utilized one or more FRPs.
• Development of a "metro map" visualization to illustrate FRP elements and their impact on review times.

Main Results:

• Development times varied significantly, from 1,458 days (BTD + PR + AA) to 3,515 days (PR alone).
• Priority Review (PR) alone had a median approval time of 242 days.
• The combination of Fast Track (FT) + Priority Review (PR) was most common (n=21), with a median approval time of 292 days.
• The fastest approval times were observed for PR + FT + BTD + AA (145 days) and PR + BTD + AA (166 days).

Conclusions:

• Combining multiple FDA facilitated regulatory pathways (FRPs) demonstrably shortens drug development and review timelines.
• The synergistic effect of multiple FRPs provides greater time efficiencies than Priority Review (PR) alone.
• Strategic utilization of combined FRPs can accelerate the availability of new therapies to patients.