FDA Renews RFID Call in Drug Anti-Counterfeit Push

In what is viewed as an effort to push industry to more quickly adopt radio-frequency identification (RFID) for anti-counterfeiting, the FDA will "fully implement" regulations related to the Prescription Drug Marketing Act of 1987, requiring drug distributors to provide documentation of the chain of custody for drug products throughout the distribution system, the agency said in a report released June 9 by its Counterfeit Drug Task Force.

A potential new measure to safeguard the drug supply is the use of electronic track-and-trace technology such as RFID, which creates an electronic pedigree for tracking the movement of the drug through the supply chain, the agency said unveiling its task force report.

"There is no question the FDA is disappointed by industry's slow adoption of RFID," former Senior Associate Commissioner for Policy and Planning Bill Hubbard told PIR June 16. "Dropping the stay is a fairly big deal" and demonstrates that the agency feels that industry "dropped the ball" by not pursuing RFID more aggressively on its own, he said.

The FDA had placed on hold certain regulatory provisions because of concerns raised at the time about the effect on small wholesalers. Most recently, in early 2004, the FDA delayed the effective date of certain regulatory provisions regarding pedigrees to allow the industry time to adopt electronic technology for tracking drugs through the supply chain.

"FDA in 2004 told industry to get cracking" on RFID, but industry has not generally done so, Hubbard said, who was then at the agency pushing RFID in meetings with drug wholesalers and others in the supply chain. "We thought wholesalers were on board in 2004, but they ended up balking at the investment". The standards issue has also been a hurdle, he added.

FDA Expectations

Based on information from drug-supply stakeholders, the FDA said it had expected RFID to be in "widespread use" in the drug supply chain by 2007, but "it now appears that these expectations will not be met," the agency said in a June 9 statement.

The FDA said it had not heard that concerns remained regarding the impact on small wholesalers and, in fact, it "was encouraged by most drug stakeholders to allow the hold to expire." Doing so would also provide clarity in the drug supply chain regarding who is and is not required to pass a pedigree, the agency said.

"Continuing the hold would perpetuate the current confusion and further allow opportunities for counterfeit and diversionary practices," the agency said. The hold expires in December.

"RFID is almost inevitable," SupplyScape CEO Shabbir Dahod told PIR. While RFID may not ever make technical or economic sense for some products -- such as unapproved biologics -- most product lines over the next five to 10 years will add barcodes of some kind, he predicted. SupplyScape offers supply chain security software and expertise designed to safeguard and secure the pharmaceutical supply chain.

"It is fairly clear RFID will happen in the industry," Hubbard said, but the timeline is still unclear, he stressed. It may come down to whether smaller wholesalers press for removing the exemption or industry comes together on standards and moves forward with RFID or other track-and-trace technology. "The right outcome is RFID," he said.

Other FDA Recommendations

During 2006, enforcement of the FDA's pedigree regulations will focus on products most susceptible to counterfeiting and diversion, the agency said. It intends to announce in the Federal Register the availability of a draft compliance policy guide for public comment describing this enforcement approach. By providing guidance on the types of drugs that are currently of greatest concern to the FDA, the agency intends to give wholesale distributors a better idea on where and how to focus their initial energies to comply with the regulations (21 CFR Part 203) for all the prescription drugs they distribute. The draft guidance clarifies how the FDA intends to prioritize its pedigree-related enforcement resources in 2007.

The task force report also underlines the agency's belief that widespread use of epedigrees using electronic track-and-trace technology, including RFID, would provide an electronic safety net for the nation's drug supply. The report recommends that stakeholders continue to work expeditiously toward that goal, and that their implementation of RFID technology be used first on products most susceptible to counterfeiting and diversion.

The task force report includes several key electronic track-and-trace issues in need of resolution, including:

Technical aspects of the mass serialization of marketed drugs by assigning a unique identifier or serial number to each drug package as the initial step in development of track-and-trace technology; Importance of a nationwide universal drug pedigree with uniform information instead of state laws imposing different pedigree requirements; Protection of consumer privacy to prevent unauthorized disclosure of information stored in RFID tags when RFID-tagged drug products are dispensed to consumers; and Consumer education about RFID and the labeling of RFID-tagged drug products to disclose to consumers when they are receiving RFID-tagged products and to inform consumers of the benefits of RFID technology and how privacy is being protected.

The FDA report is largely based on the task force's recent findings in numerous contacts with stakeholders, including a February public workshop, public comments and monitoring of the latest technological developments.

The task force report is the third in a series of documents exploring the means of ensuring the safety of the U.S. drug supply. The first report, issued in 2004, outlined the framework for protecting the public from counterfeit medicines and the second report, released last year, assessed the progress toward implementing the 2004 recommendations. All task force reports are posted on FDA's website at www.fda.gov/counterfeit (http://www.fda.gov/counterfeit). -- Michael Causey