Preapproval inspections to focus on data integrity and fraud

Executive Summary

CDER official Rick Friedman asserted that FDA's action was prompted by recent criminal investigations, including the Department of Justice's prosecution in March 2007 of a former vice-president in charge of quality control and three supervisory chemists who pleaded guilty to conspiracy involving the rampant falsification of records. "We have found other deficiencies including acceptance of failed runs," reported Friedman at a June 23 conference in New Brunswick N.J. sponsored by Pharma Conference and the University of Rhode Island College of Pharmacy. "This has shown that many of these investigations are undermining the safety and efficacy of these products." Other examples of fraud include biased manipulation of study data, alternating weights of samples and changing weights of standardized samples. To combat this problem, FDA is "reinvigorating" specialized training of investigational staff to address data integrity, manipulation and fraud issues. Friedman recommended that manufacturers "train employees in proper data handling and reporting. Employees need to know how to identify suspect data in clinical trials and how to identity suspect GMP data. Everyone in the organization needs to be responsible for data integrity