Counterfeit Drug Task Force Report: June 2006

Department of Health and Human Services

Public Health Service Food and Drug Administration Rockville MD 20857

DATE:

June 8,2006

TO:	Randall Lutter, Ph.D. Associate Commissioner for Policy and Planning Margaret Glavin Associate Commissioner for Regulatory Affairs

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.

 

Contents

• Counterfeit Drug Task Force Report 2006 Section IV: What is the status of electronic track and trace across the drug supply chain?