FDA wants prescription drugs tracked

The Food and Drug Administration plans to require drug manufacturers to start tracking distribution of high-priced drugs throughout the pharmaceutical supply chain this December, using technology it calls the most promising, radio frequency identification (RFID).

But the FDA said the use of RFID technology to create an electronic pedigree to trace the sale of all prescription drugs from manufacturer to corner pharmacy will not be adopted in 2007, as the FDA had anticipated.

Congress originally passed the Prescription Drug Marketing Act, which calls for the pharmaceutical industry to track drug shipments, in 1987, but the FDA has delayed enabling regulations since then because of complaints from secondary wholesalers, congressional overseers and technological hurdles.

The FDA planned to use RFID to detect counterfeit drugs since 2004. In a report released last week, the agency said it 'had expected this technology to be in widespread use in the drug supply chain by 2007'. It now appears that FDA's expectations for adoption of the technology by 2007 will not be met.''

The FDA Counterfeit Drug Task Force recommended in its report to FDA Acting Commissioner Andrew von Eschenbach last week that it was time for the agency to institute regulations in a nearly 20-year-old legislation. Von Eschenbach approved with a phased approach.

The FDA issued a draft Compliance Policy Guide (CPG) last week that states that the agency intends to focus its enforcement of drug tracking on those most vulnerable to counterfeiting or diversion, including drugs with a high sales volume such as cholesterol-reducing Lipitor, expensive specialty drugs, or high-demand drugs such OxyContin, an often-abused painkiller and Tamiflu, whose use could skyrocket in a pandemic.

Paul Chang, an associate partner at IBM Business Consulting Services, said pharmaceutical companies whose products fall in the categories the FDA outlined in its CPG have already started to trace and track the drugs.

Pfizer, for example, started tracking all shipments of Viagra last December, while Purdue Pharma has tagged shipments of OxyContin since 2004.

The entire pharmaceutical supply chain should be able to use e-pedigrees in the near future, the June 2006 FDA Counterfeit Drug Task Force Report states.

The task force understands the complexity of the pharmaceutical industry's adopting e-pedigrees overnight and recognized that using a combined paper and electronic approach may be needed during a transitional period, the report states.

The task force report called RFID the most promising technology for tracking and tracing the drug supply chain with hybrid RFID/bar code systems achievable in the near future.


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