Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Rockville MD 20857
Randall Lutter, Ph.D.
|FROM:||Andrew vonEschenbach, MD|
Acting Commissioner of Food and Drugs
Thank you for submitting to me the Counterfeit Drug Task Force Report - 2006 Update. I strongly concur that increasing the safety and security of the nation's drug supply and protecting it from the increasing sophisticated threat of counterfeit drugs is critically important. I commend you and the rest of the Counterfeit Drug Task Force on your efforts in developing this report and its recommendations to further this goal. I appreciate the fact-finding efforts that the Task Force undertook, such as holding the February 2006 public workshop and soliciting public comment, to understand the issues and provide me with informed recommendations.
I endorse the report and its recommendations. This includes the recommendation not to further extend the stay and to issue a compliance policy guide (CPG) that discusses FDA's enforcement focus regarding pedigree requirements. Please move forward with these recommendations, pursuant to FDA's good guidance practice (GGP) process (21 CFR § 10.1 15), as appropriate.
Counterfeit Drug Task Force Report 2006 Sections I and II: Introduction and Background Counterfeit Drug Task Force Report 2006 Section III: What is next for PDMA Implementation? Counterfeit Drug Task Force Report 2006 Section IV: What is the status of electronic track and trace across the drug supply chain? Counterfeit Drug Task Force Report 2006 Section V: What technical issues related to electronic track and trace need resolution?