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U.S. Department of Health and Human Services

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Counterfeit Drug Task Force Report: June 2006

Department of Health and Human Services logo   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 ยง 10.1 15), as appropriate.

 

Dr. von Eschenbach's signature