Fighting Counterfeit Drugs

While full implementation of an RFID/EPC system to track and trace pharmaceutical products from manufacturer to the pharmacy may be some years away, federal regulators and industry leaders alike believe the technology offers the best weapon in the battle against counterfeit drugs.

On May 18, the U.S. Food and Drug Administration (FDA) said its Office of Criminal Investigations initiated 58 counterfeit drug cases in 2004, up from 30 cases initiated in 2003. Most of the drugs involved, FDA said, were destined for the black market or internet distribution.

Last September, FDA also advocated implementation of electronic track and trace mechanisms and called radio--frequency identification (RFID) the "most promising technology" to meet that need. It said "tremendous progress" has been made over the last year in the development and implementation of EPC/RFID, which it called "a huge endeavor that requires close collaboration among all constituents of the pharmaceutical distribution system." FDA added that a critical component is development of standards to be used and the systems for storing and sharing information about the history of a specific drug product, its "pedigree."

Last November, FDA issued a Compliance Policy Guide for implementing RFID feasibility studies and pilot programs, and said last month that several companies are moving forward with programs involving the tagging of products susceptible to counterfeiting.

"In fact," according to FDA, three major pharmaceutical companies plan to incorporate an RFID tag into at least one of their products by the end of 2005. In its May 18 "update" of last year's report, FDA promised to play an active role in public-- and private-- sector efforts toward developing an "electronic safety net" for the drug supply, including adoption and widespread use of reliable track and trace technology by 2007.

Meanwhile, the Pharmaceutical Re--search and Manufacturers Association (PhRMA) on May 13 urged a streamlined approach to help secure the U.S. pharmaceutical supply chain while a comprehensive program for use of RFID is developed.

PhRMA disagreed with FDA that such a system can be in place by 2007, contending it is five years away. Thus, the association said, other short--term measures, such as establishing a paper trail "pedigree" and using barcodes on product packaging are needed.

"The implementation of an RFID--based electronic pedigree system is likely to be complex and not fully achievable for five or more years," PhRMA said in a white paper on the subject. "Current use of RFID chips is limited by robustness and the impact on the affordability of medicines."

"Even if stakeholders could quickly resolve the complex technological, legal, regulatory and policy issues associated with establishing a nationwide, electronic pedigree system throughout the distribution chain, there are still basic scientific issues that need to be addressed, such as the readability of RFID tags at the item, case and pallet level," the association contended.

An interim solution, PhRMA said, is to focus authentication efforts at the point of manufacturer and at the pharmacy, where the drug is dispensed. "The dispensing site is a critical link in the drug distribution chain since it is the last stop before a drug is dispensed to a patient." the document said. "Authentication of drug products at this juncture would have a direct, immediate and lasting impact on patient safety."

It said the goal of "real--time authentication" at the dispensing site can be done with mass serialization and available electronic technology, including barcoding or RFID tags, when available. Electronic authentication, PhRMA said, is more direct, less complex (than establishing a track and trace system across the supply chain), could be implemented more expeditiously, expanded easily, and provide immediate safety benefits to patients.

Several states, including California and Florida, are seeking to impose legislative requirements for establishment of a detailed paper trail for each prescription drug sold. The federal Prescription Drug Marketing Act also requires such a system, but objections by the industry have delayed implementation.

The association proposed, instead, implementing electronic authentication in stages, with a simplified information infrastructure allowing RFID issues to be resolved, but also providing immediate safety benefits during the implementation period. Coupled with a paper pedigree system to fill in the authentication gaps, the approach would offer immediate benefits and safeguards, PhRMA said.

The Healthcare Distribution Management Association (HDMA), which represents distributors of prescription drug products, said it was encouraged by both FDA and PhRMA statements.

"HDMA strongly believes that technologies such as EPC/RFID play an important role in securing the prescription drug supply, though we agree with FDA and PhRMA that no single solution will prevent drug counterfeiting," said HDMA President and CEO John M. Gray. He said his group would continue working with distributor members, manufacturers, pharmacies and lawmakers to develop and implement a multi--pronged anti--counterfeiting solution.

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