Performance Improvement 2007. Did the “Continuous Marketing Application” Pilots Increase the Efficiency and Effectiveness of the New Drug Review Process?

01/01/2007

Summary:

This study evaluated the Food and Drug Administration’s (FDA's) Continuous Marketing Application (CMA) Pilots 1 and 2. The two pilot programs were established under the Prescription Drug User Fee Act III (PDUFA III). PDUFA is a series of laws that allows the agency to help fund the review of new drugs through fees paid by the companies that submit new drug applications. PDUFA was first enacted in 1992 and has been reauthorized twice, each time for five years, in 1997 and 2002, respectively. The two pilots were designed to test whether providing early review of selected applications and additional feedback and advice to sponsors during drug development for selected products can further shorten drug development and review times. Pilot 1 involved a commitment on the part of FDA to review and provide feedback to the sponsor within 6 months of submission of "reviewable units" of an application in advance of the submission of the complete application.

This pilot program represented an extension of the "rolling review" program begun under the Food and Drug Act Modernization Act of 1997 and was limited to applications that had received a "Fast Track" designation. Pilot 2 involved a commitment on the part of FDA to provide more structured and extensive interaction and feedback to sponsors for up to one Fast Track application per review division during drug development. This pilot represented an extension of the usual interactions between FDA and sponsors during drug development. To evaluate the costs and benefits of these pilots, FDA commissioned an independent assessment. The evaluation included interviews of FDA employees and product sponsors who participated in the pilots. Also interviewed were sponsors with eligible drug products who did not participate in the pilots. The non-pilot, eligible products sponsors formed a comparison cohort against which the pilots were measured. In addition to interviews, the evaluation examined data from product action packages, FDA's time tracking system, the PDUFA goal date tracking system, and the document filing system.

The study did not reach any conclusions about whether either pilot program should be continued. However, after review of the findings, FDA and industry representatives agreed that although the pilots demonstrated value in some areas, the overall added benefits of the programs did not justify their costs to FDA. Therefore, FDA is proposing to recommend that the pilot programs not be continued in the upcoming reauthorization of the Prescription Drug User Fee Act (PDUFA IV). Recommendations regarding the upcoming reauthorization were published in the Federal Register on January 16, 2007 (Vol. 72, No. 9/Page 1743).

Report Title: Independent Evaluation of the FDA's Continuous Marketing Application Pilot 1 and Pilot 2: Initiatives & Evaluations http://aspe.hhs.gov/pic/fullreports/06/8312.pdf
Agency Sponsor: FDA, Food and Drug Administration
Federal Contact: Bobolis, Mary A., 301-827-5253
Performer: Booz Allen Hamilton; McLean, VA
PIC ID: 8312

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