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Post-marketing study

This article was originally published in The Tan Sheet

Executive Summary

FDA has awarded consulting firm Booz Allen Hamilton a $1.1 mil. contract to "examine in-depth the agency's internal process regarding [post-marketing commitments] and make recommendations regarding ways to improve our PMC process and practices," the agency announces April 5. Results from the study are not expected to directly affect existing Phase IV commitments, according to FDA. The study, slated to begin in April, will likely take one year to complete and will "evaluate the consistency of the process within FDA divisions and across Centers for requesting and reviewing" PMCs, Booz Allen said. The agency said it will help facilitate the study and provide feedback to Booz Allen on submitted draft reports before they are finalized. FDA said in February that it plans to retain a contractor to recommend improvements to the Phase IV commitment process. Many industry observers have noted that the increased importance of post-marketing commitments will likely play a part in product approval decisions due to drug safety concerns...
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