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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 § 10.1 15), as appropriate.

 

Dr. von Eschenbach's signature

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