Protecting High-Risk Products

While FDA’s 2006 update on counterfeit drugs does not mandate the use of radio-frequency identification (RFID), it does show that the agency still strongly believes that the technology can be an effective weapon against counterfeiting and diversion. FDA plans to let its stay on drug pedigrees (defined in the Prescription Drug Marketing Act) expire toward the end of the year, and the agency says that it expects “supply-chain stakeholders will move quickly to adopt electronic track-and-trace technology, implementing RFID in a phased-in approach.”

FDA will, however, accept a hybrid approach to pedigrees, in more ways than one. The agency says it will accept paper or electronic pedigrees, and it does “recognize that the goals can also be achieved by using other technologies, such as 2D bar codes.”

Such acceptance aside, most of the report offers recommendations on implementing RFID, encouraging stakeholders to “expeditiously implement widespread use of electronic pedigrees across the supply chain.” FDA even calls manufacturers (along with wholesalers and retailers) “slow to implement” RFID.

FDA acknowledges the following challenges to RFID use:

• A lack of standards (for e-pedigree fields and format, data systems, international transmission standards, and hardware specifications).

• Privacy concerns.

• Concerns about the ownership of confidential business transaction data.

• Challenges in serializing all products.

• Concerns over the accuracy and speed of electronic devices and systems.

• A lack of definitive data to determine how RFID will affect sensitive products (e.g., liquids, biologics).

But FDA appears confident that vendors are working to meet these concerns and that stakeholders are close to standardizing RFID use, factors that could ease implementation.

As such, FDA recommends “that stakeholders consider a phased-in approach, placing RFID tags on products most vulnerable to counterfeiting and diversion as a first step.”

The agency defines vulnerable products as those that are likely to be counterfeited, such as high-priced, high-value, high-demand products or products that are in short supply or that have once been counterfeiting victims. “Consistent with our risk-based approach to the regulation of pharmaceuticals, during the next year,

FDA intends to give higher priority to enforcement efforts regarding the pedigree requirements in 21 U.S.C. § 353(e)(1)(A) and 21 CFR Part 203” for these vulnerable drugs, according to its “Draft Compliance Policy Guide 160.900, Prescription Drug Marketing Act—Pedigree Requirements under 21 CFR Part 203.”

Products mentioned by FDA by name include Viagra, Procrit, Zyprexa, Serostim, Tamiflu, Combivir, Epovir, Sustiva, Trizivir, Zerit, Diflucan, Lamisil, immune globulin (IGIV), Gamimune, Gammagard, Epogen, Lipitor, Nexium, Risperdal, Plavix, Oxycontin, certain metered-dose inhalers, and reserpine tablets.

FDA also stands behind the use of the National Drug Code (NDC) number on all prescription drug packages. But it understands some of the privacy concerns that RFID use could raise. While FDA recommends that the NDC number “should continue to be closely associated with the product,” it says that “for non-line-of-sight technology, such as RFID, the unique identifier for the product should either include an encrypted NDC number or an accessible link to the NDC number to protect privacy.”

FDA includes further discussion on data management, “turning off” RFID tags, and RFID labeling disclosures for patients, among other points. But these recommendations clearly involve the use of RFID, not paper or bar codes. As a result, while FDA says it “should not mandate RFID,” it spends an awful lot of time encouraging it.

For more information on the report, visit www.fda.gov/oc/initiatives/counterfeit/report6_06.html. For the compliance policy guide, visit www.fda.gov/oc/initiatives/counterfeit/cpg.html.