Performance Improvement 2009. How Can the Food and Drug Administration Improve Efforts to Assure That Drugs Approved for Sale Are Safe, Effective, and Optimal?


This study identified possible improvements to the Food and Drug Administration post-marketing commitment (PMC) processes. FDA evaluates new drug and biological products prior to approval for marketing in the United States and may request that a sponsor seeking approval of a new drug or biological product conduct a post-marketing study to provide additional information about the safety, efficacy or optimal use of a drug or biological product. Such studies are important but not necessary for approval to market the product.

The study found that the post-marketing commitment processes positively impacted public health, but need to be used judiciously to ensure that only commitments addressing important issues regarding safety, efficacy and optimal use are requested. Sponsors generally agreed that the PMC program had a positive public health impact. More than half of fulfilled PMCs assessed in the study resulted in a label change. The most common reasons for the label changes were validated safety and efficacy concerns, validated drug-drug interaction concerns, and expanded use in subpopulations. However, 50 percent of sponsors questioned the value and/or rationale of PMCs. These sponsors noted that in some cases, the supporting studies were ongoing at the time of approval of the product, and the PMC was simply a mechanism to ensure the results were submitted to FDA. Others reported that they believed the PMC supported a reviewer's academic interests. PMC milestones agreed on by FDA and the sponsor were not always met. The main reason for FDA failure to meet review goal dates was competing workload priorities.

Report Title: Independent Evaluation of FDAs Prescription Drug User Fee Act III -- Evaluations & Initiatives -- Task Order 4 -- Post Marketing Commitments Study Report
Agency Sponsor: FDA, Food and Drug Administration
Federal Contact: Judith Arndt, 240-276-3234
Performer: Booz Allen Hamilton
PIC ID: 8948

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