FDA Revisits RFID and Drug Pedigrees - Pharmaceutical Technology

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FDA Revisits RFID and Drug Pedigrees

Pharmaceutical Technology

Establish standards for electronic data communication. EPCGlobal (Lawrenceville, NJ, http://www.epcglobalinc.org/), an international, nonprofit organization, has formed a healthcare action group to develop e-pedigree standards on the basis of a universal interchange format that trading partners can use to send and receive pedigrees in a secure manner. Standards address pedigree messaging, item-level tagging, serialization, RFID frequencies, and network security. Most leading pharmaceutical manufacturers are involved, along with large distributors, retail pharmacies, hospitals, and FDA. Pedigree data elements will include information about the drug product, the specific item (lot number, expiration date), date of transaction, and trading partner.

Gain consensus on data management, storage, and access. A key issue is whether all the transaction information should be stored in a single central database or throughout the distribution network. Related concerns are who should have access to what information. Manufacturers propose that data on package units be routed to distributed databases that can signal a dispensing site in real time that the identification number is authentic.

Use diverse authentication technologies. Manufacturers are adopting a range of strategies to protect drugs from illegal copying and tampering. Various inks and coatings can be used to identify genuine packages, blister packs, and individual pills. Overt technologies include color shifting inks and holograms that can double as an antitampering seal. More sophisticated covert technologies—invisible chemically reactive markers and quantum photonic markers that show up under certain lights—are more difficult for counterfeiters to detect and copy. Desirable technologies have minimal impact on manufacturing processes, are easy to authenticate in the field and can be applied to multiple products and packaging components to support a corporate approach to product security across brands and regions.

Test for effect of tags and markers on pharmaceutical and biotech products. Although most inks and colorings used on tablets and drug packaging do not cause adulteration, the heat from RFID tagging systems could have thermal effects on chemical bonds in some products.

Seek additional FDA guidance. Manufacturers hope that FDA's May report will contain further advice about how to develop unique identifiers for drug packages, handle transaction data and whether any colorants or other authentication technologies are likely to effect product dissolution, stability, or identification.

Address patient privacy. RFID tagging raises the prospect that information about an individual consumer's drug use could be fed into a data system without the patient's permission or knowledge. The Federal Trade Commission (FTC, Washington DC, http://www.ftc.com/) has been examining how electronic data that can be read from a distance could lead to surreptitious information collection.

Develop new business models and policies. Although RFID and authentication methods may appear too costly for all but the most vulnerable products, these strategies may pay off for manufacturers by improving supply and distribution systems, enhancing public confidence in company products, and avoiding costly lawsuits from consumers who are harmed by an adulterated version of the company's product. Lack of internal security measures and failure to adequately monitor products through the distribution system may create legal and regulatory problems for manufacturers in the future.

Beef up enforcement. FDA points to a rising number of counterfeit drug cases brought by its Office of Criminal Investigations (OCI) as a sign that the agency is taking drug diversion seriously. The Department of Justice (DOJ) also is expanding efforts to combat drug counterfeiting as part of its campaign against crimes involving intellectual property protection.

More than RFID

Although electronic track-and-trace still dominates discussions about effective prescription drug protection, there is a growing realization that RFID is primarily a supply chain management tool and is not very useful in product authentication.

RFID currently is the most advanced tracking technology, commented FDA's Gottlieb, but he noted a need to pursue a multilayered approach that includes use of two-dimensional bar codes and other technologies.

Gottlieb also acknowledged a need for stiffer penalties on lawbreakers and expanded enforcement and detection efforts. And, he suggested that the government may look for new ways to encourage drug security methods. One idea, he suggested, might be to require authentication technologies on drugs purchased for the national stockpile; a case could be made that product tracking would be important for medicines distributed broadly during a national emergency.

Jill Wechsler is Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634,


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