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FDA Will Require Wholesalers to Track Drugs

On June 9, 2006 the U.S. Food and Drug Administration (FDA) announced that drug wholesalers will be required to supply a "pedigree," or record of all drugs they sell. The pedigree, which may be in either paper or electronic form, will need to show all the "middlemen" who have handled drugs once they have left the wholesaler. The FDA is asking wholesalers to comply with this rule by December 2, 2006. The agency is taking this step in order to counteract the increased prevalence of counterfeiting, based upon recommendations made by its own Counterfeit Drug Task Force.

Read FDA Counterfeit Drug Task Force Report >>

The statistical rise in counterfeit drug cases has been dramatic. The FDA reported six drug counterfeit cases in its fiscal year 2000; by 2004-2005 the number had risen to 90 cases. By urging wholesalers to trace the distribution of pharmaceuticals, the agency expects to prevent fake or non-FDA approved drugs from reaching and potentially harming consumers.    

"The adoption of the FDA Counterfeit Drug Task Force's recommendations will further reduce the risk that counterfeit products will enter the U.S. drug distribution system and reach patients," said Dr. Andrew C. von Eschenbach, FDA Acting Commissioner. "We must remain vigilant in our efforts to ensure our nation's drug supply is protected against an increasingly sophisticated criminal element engaging in a dangerous type of commerce."

Read the entire FDA announcement >>

Source: The Wall Street Journal and FDA news release both dated June 9, 2006


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