Pfizer is working with FDA to allow use of data matrix bar codes on drug product units of sale.

The manufacturer is proposing to "migrate [its] unit dose bar codes to data matrix," Pfizer Director-Trade Operations & Customer Service Byron Bond said at the Healthcare Distribution Management Association conference in Las Vegas June 17.

Pfizer uses reduced space symbology bar codes, RSS-14, on unit dose packages, Bond said. "If we knew a few years ago what we know now, we probably would have gone with data matrix."

FDA's bar code final rule allows for use of linear bar codes; data matrix coding is two-dimensional (¹ Also see "FDA Bar Coding Final Rule Sets Two-Year Implementation Timeline" - Pink Sheet, 1 March, 2004., p. 6).

Although data matrix coding is cheaper than radio frequency identification technology, in the long-term Pfizer plans to use RFID "on all units of sale, cases and pallets as technology advances permit."

FDA has said it expects RFID to be the standard track-and-trace technology for drugs by 2007, with serial identification of all pallets and cases of pharmaceuticals, and the serialization of most drug packages (² Also see "FDA Anticounterfeit Carrot & Stick: Radio Frequency I.D., No Paper Pedigree" - Pink Sheet, 23 February, 2004., p. 14).

However, the agency does not plan to require implementation of RFID.

Bond noted that use of data matrix as an interim step could delay the shift to RFID. "If it works, going to RFID might be delayed several years."

FDA is becoming more flexible on the use of data matrix and the timeline for implementing RFID, Pfizer said. The company estimates that RFID will be widely used by 2012.

During a Federal Trade Commission workshop June 21, FDA Senior Advisor for Medical and Health Policy Paul Rudolf noted that two-dimensional bar codes have some near-term advantages.

While "two-dimensional bar codes can also contain a unique number and can also be scanned, we felt that RFID offered a large number of advantages to 2D bar coding for serializing pharmaceutical packages, cases, pallets," he said.

"However, 2D bar coding can be used right now," he said. "There's a lot of discussion in the pharmaceutical industry about what's the best near-term way of serializing all packages of drugs."

Rudolf also noted that 2D bar codes may be more cost-effective for generic drugs.

"People talked about, 'Well why would you put a $5 or 5¢ chip on something that's only worth 5¢,'" he said.

"There are a lot of generic drugs where a bottle of hundred might not sell for more than a dollar or two, and there are issues about whether RFID will be used on those bottles or what the business case would be for that."

"That's one of the reasons why we have also thought that in some cases 2D bar coding could be used for certain products," Rudolf said.

Bond emphasized the importance of working in collaboration with other firms to develop standards for counterfeiting technology.

"Pfizer does not have the reputation for being the most kumbaya," he said. "We tend to do things our way, our speed. However, we quickly came to the recognition that there is no way that Pfizer could do this alone."

"We are not the Wal-Mart of the pharmaceutical industry. We can't just unilaterally come out and say 'this is the right way to do things.'" Pfizer is a member of the "Jumpstart" anti-counterfeit technology coalition (³ Also see "Rx Industry “Jumpstarts” Anti-Counterfeit Technology Through RFID Coalition" - Pink Sheet, 10 May, 2004., p. 38).

In addition to bar codes and RFID, Pfizer plans to expand its anti-counterfeiting efforts for its erectile dysfunction drug Viagra by introducing color-shifting labels. "We are introducing in the U.S. for the first time color-shifting technology on our labels," Pfizer VP-U.S. Trade Group Tom McPhillips said June 16.

"We think that will be something that will be more challenging...to knock off," McPhillips said.

McPhillips indicated the company will likely expand the use of color-shifting labels beyond Viagra. In addition to Viagra, Lipitor has been the target of counterfeiting in recent years.

Pfizer Views Data Matrix Bar Codes As Road To Radio Frequency I.D.

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