FDA Announces ‘Pedigree’ Requirements for Tracking Drugs Through Wholesalers

The FDA on Friday is scheduled to announce a new rule that will require pharmaceutical wholesalers to track who handles the drugs they distribute, the Wall Street Journal reports. Under the new rule, wholesalers will have to supply a "pedigree," tracing every entity that has handled the drugs since they left the manufacturer. The pedigree, which can be in paper or electronic form, will include addresses and the lot number of the drugs. FDA said that for the first year the law is in effect, the agency will implement enforcement based on a drug's market value, whether it is used to treat a particularly serious condition and its history of counterfeit concerns. The new law does not apply to wholesalers who have been designated as "authorized distributors" by drug manufacturers, so it "will thus be focused largely on secondary wholesalers, rather than the large primary wholesalers" -- McKesson, Cardinal Health and AmerisourceBergen -- that "handle most drugs," the Journal reports. The new rule will take effect Dec. 2.

Implications
According to the Journal, the rule is designed to "close a legal loophole that has made it difficult to trace the true origin of some medications." FDA has "repeatedly" stayed a 1999 rule designed to implement a pedigree requirement established by a 1988 law, most recently because the agency said it hoped that new technology, such as radio tags to track drugs, might soon be put into wider use, the Journal reports. According to a report to be released on Friday by the FDA counterfeit drug task force, FDA can "no longer justify delaying implementation of these regulations" and is "disappointed with the lack of overall progress across the drug supply chain" toward implementing use of radio tags. The report adds that further delay "would perpetuate the current confusion and further allow opportunities and diversionary practices to flourish." FDA opened 32 counterfeit investigations in fiscal year 2005 and 58 in FY 2004, compared with six in FY 2000, according to the agency.

Comments
Margaret Glavin, FDA associate commissioner for regulatory affairs, said there have been cases when "counterfeits have gotten into legitimate retail sales," adding that the new rule "will make it much more difficult to breach that supply chain." Robert Drucker, CEO of secondary wholesaler RxUSA Wholesale, said there is "no legitimate business reason" why the large wholesalers should be exempt from the pedigree requirement (Wilde Mathews/Won Tesoriero, Wall Street Journal, 6/9).