Review of Food and Drug Administration's Bone Mass Study

EXECUTIVE SUMMARY:

This final report responds to a letter from the Commissioner of Food and Drugs, requesting that we perform a review of a clinical study that examined dietary supplements' ability to increase bone mass.  The objectives of the review were to determine if the Food and Drug Administration (FDA) (1) could do more to locate or account for the study's allegedly missing medical folders and (2) had an accurate and supportable financial report of the study's transactions.  Regarding the missing medical folders, we concluded that additional search would not be useful.  The exact number of folders and their contents may never be known because FDA did not establish clear responsibilities for creating, updating, and filing the folders in question.  The lapse also poses an ongoing risk that medical information on the subjects involved in the study could be released without their authorization.  Regarding the financial accounting issue, we found inaccurate and unsupported entries in information provided by FDA.  The FDA concurred with our recommendations to correct these issues.