OIG Finds Thousands of Errors in FDA's Drug Code Directory
The Office of the Inspector General ("OIG") of the United States Department of Health and Human Services has reported that the Food and Drug Administration's ("FDA") National Drug Code Directory (the "Directory") contains thousands of errors. The OIG's inspection uncovered that over 9,000 prescription drugs are missing from the Directory and the Directory included almost 35,000 drugs that are no longer on the market or are listed in error. The OIG attributes these errors, at least in part, to the FDA's failure to include drugs reported by drug companies and the failure of many drug companies to submit the requisite FDA reporting forms.
The Directory assists the FDA with implementing compliance programs and health initiatives. For example, the FDA references the Directory when it recalls drugs and undertakes bioterrorism efforts. The OIG recommends several measures that the FDA should take to improve its process, including implementing a mechanism to uncover errors and omissions and penalizing drug companies that fail to report and update their information. To view the OIG's report, visit http://oig.hhs.gov/oei/reports/oei-06-05-00060.pdf
