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FDA Cites Progress for Drug Security

The U.S. agency says the pharmaceutical industry has made strides toward establishing an RFID-based system for protecting the nation's drug supply.
By Elizabeth Wasserman
May 24, 2005The U.S. Food and Drug Administration says "significant progress has been made" toward implementing measures the agency outlined last year, including the securing of the pharmaceutical supply chain through the adoption of RFID. The FDA last year endorsed the use of RFID tags containing unique electronic product codes (EPC) to electronically track and trace every package of medication through the supply chain.

"We consider this an electronic safety net for the nation's drug supply," Ilisa Bernstein, the FDA's senior advisor for regulator policy, said during a panel discussion about RFID at the National Press Club in Washington, D.C., on Monday night. "In the past 15 months, we've seen tremendous progress in implementing electronic track and trace."

Ilisa Bernstein
Bernstein said the progress includes RFID tagging pilots that have been initiated by drug manufacturers, retailers and others in the pharmaceutical supply chain. Manufacturers such as Pfizer and GlaxoSmithKline have participated in RFID pilots tagging certain medicines, as have three of the nation's largest drug distributors: Cardinal Health, AmerisourceBergen and McKesson. A few major drugmakers—including Pfizer, maker of Viagra, and Purdue Pharma LP, which makes OxyContin—plan to incorporate RFID tagging into at least one product line by the end of 2005. In addition, manufacturers, distributors and retailers in the drug distribution system have gotten together through EPCglobal to develop RFID standards for the pharmaceutical industry and determine the systems needed for storing and sharing the data (see Pharma Groups Work on EPC Issues). Furthermore, several states—most prominently Florida and California—have started adopting laws to more strictly control the drug distribution chain by requiring a pedigree, a record that documents and authenticates each step in the chain of custody for a drug.

Despite these measures toward securing the pharmaceutical supply chain, the number of criminal investigations into prescription drug counterfeiting in the U.S. grew dramatically in 2004, nearly doubling from the previous year, according to a newly published annual update to the FDA's landmark report "Combating Counterfeit Drugs," which the agency published in 2004 (see FDA Endorses RFID Technology).

The FDA's Office of Criminal Investigations opened 58 probes into counterfeit drugs last year, a sharp increase from the 30 cases the agency initiated in 2003. The update says the increase is, in part, due to "an increased awareness and vigilance at all levels of the drug distribution chain." In addition, the update credits law enforcement agencies with referring possible criminal drug counterfeiting cases to the FDA. Bernstein acknowledged that the public health threat is real and that counterfeiting has been growing worldwide, but she emphasized that the U.S. distribution system is the world's safest, adding that the numbers didn't necessarily mean there was more drug counterfeiting. In fact, the suspected counterfeit drugs discovered in 2004 were in smaller quantities than those found in previous years, and most of the drugs were to be sold on the black market or through Internet distribution, not destined for widespread distribution in the nation's drug supply chain.

Bernstein said that officials at the agency are optimistic that the pharmaceutical industry will have in place widespread use of track and trace technologies—most likely RFID—by 2007. She noted that the agency has not attempted to pass regulations requiring compliance but that the industry has been responding to the agency's concerns. The FDA report states that the agency will continue to "regularly review the extent and pace at which RFID is being adopted," and encourage research on the potential impact of RFID on drug and biological products.

Among the next steps for the FDA, according to Bernstein, is to try to alert health professionals and pharmacists of potential warnings signs of counterfeiting. The agency will also work with international organizations and foreign law enforcement agencies to provide training and strategies on combating the counterfeiting problem globally.
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