Assessing the Effectiveness of an Innovative FDA Drug Review Program

As part of its mission to protect and promote public health, the Food and Drug Administration reviews the safety and effectiveness of new drugs and biologics. Seeking to improve the effectiveness and efficiency of these reviews, FDA instituted a new program—based on enhanced review transparency and communication between FDA and applicants—to review the most innovative drugs and biologics. FDA turned to ERG to evaluate how well the program was working.

ERG conducted a comprehensive program assessment in two phases over four years. Our work involved observing industry-FDA interactions, analyzing data on industry applications for drugs and biologics, and interviewing FDA review teams and industry sponsors for every product reviewed under the program.

FDA applied the results from our assessment of the program’s first two years to further optimize the flexibility and efficiency of its review procedure—and to negotiations for the next authorization of the Prescription Drug User Fee Act. ERG’s assessment of the program’s third and fourth years demonstrated increased program effectiveness and efficiency and yielded recommendations for additional refinements. Based on the evaluation results, FDA extended the program for another five years. In addition, lessons learned from the assessment contributed to the framework for a new biosimilars review program at FDA.