OIG Trains Its Microscope On INDs, Electronic Drug Labeling, And BioShield

HHS Office of Inspector General recently released its work plan for fiscal year 2011. Below are some of the activities it is initiating in the coming year.
Subject	Investigation
FDA’s Oversight Of Investigational New Drug Applications	OIG will assess FDA’s timeliness in evaluating IND applications and identify challenges to the review process. This review is expected to issue in FY 2011.
Complaint Investigation Process	Will review the adequacy of FDA’s complaint investigation process to determine if complaints are properly recorded in the Consumer Complaint System and investigated expeditiously. Will also review FDA’s process for categorizing and using complaints to identify potentially significant trends or patterns in reported illnesses or injuries. The review is expected to issue in FY 2011.
Submission of Electronic Drug Labels	Will review FDA’s oversight of drug manufacturers’ compliance with the requirement to electronically submit drug labels for prescription drugs to FDA. Will also examine the accuracy and completeness of submissions and identify factors that result in inaccurate or missing information. The investigation is expected to issue in FY 2012.
Use of Data And Safety Monitoring Boards In Clinical Trials	Will review the extent to which Data and Safety Monitoring Boards monitor data in clinical trials. Will also determine how and to what extent NIH is ensuring that grantees comply with the NIH policy for DSMBs in multisite clinical trials. The review is expected to issue in FY 2012.
NIAID’s Oversight Of Project BioShield Grants	Will review the processes that the National Institute of Allergy and Infectious Diseases uses to monitor grantees’ compliance with federal laws, regulations and policies. Project BioShield involves R&D for medical countermeasures. The review is expected to issue in FY 2012.