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Congress Subcommittee Holds Hearing on Halting Drug Counterfeiting
"These are below-the-radar-screen types of issues, but we've been talking with folks about RFID for some time, both in the government and [in] pharmaceutical markets," says Farry, who is also the lead correspondent for his firm's RFID Law Blog. "One thing we often hear is, 'Great, but who is going to pay for that [RFID]?'"
Indeed, Susan Winckler, vice president of policy and communications for the American Pharmacists Association (APhA), testified that while APhA supports advanced technologies and other ways to combat drug counterfeiting, its support is tempered by the need to minimize the impact on patients and recognize the reality that pharmacists have limited resources in terms of time and money. "Any anticounterfeit initiatives must include assessments of both the costs and benefits," she told the subcommittee. "As Congress seeks to close gaps in our system, it must assess the impact any proposed solutions might have on pharmacists and our ability to serve patients."
Winkler was one of six speakers who presented testimony during the hearing. Others in the group included Randall Lutter, the FDA's acting associate commissioner for policy and planning; Kevin Delli-Colli, deputy assistant director of the Financial and Trade Investigations Division, Office of Investigations, U.S. Immigration and Customs Enforcement; Carmen Catizone, executive director of the National Association of Boards of Pharmacy; John Gray, president and CEO of the Healthcare Distribution Management Association (HDMA); and Rick Raber, project manager of Northern Apex-RFID, a systems integrator.
Several speakers indicated the need for coordination among various states' current and forthcoming drug-pedigree laws, as well as the development of RFID standards. The latter continues to be a concern of many stakeholders, particularly pharmaceutical companies and the FDA. Joseph Pearson, business development manager at Texas Instruments, an RFID tag and chipmaker and one of Northern Apex-RFID's business partners, says the creation of a single item-level standard for the pharmaceutical industry would be a driving factor in RFID's mass adoption in that industry, as would the passage of legislation requiring the use of RFID technology to track drugs in the supply chain.
"The hearings represent the need for congressional legislation to provide the mandate directive that the FDA is looking for," says Pearson, who did not attend the hearings, but spoke with several who did, "so they can provide the rules to implement RFID in the industry."
It is unclear where the subcommittee's hearings will lead, but Farry says Congress has numerous options at its disposal, including acting on the FDA's decision to lift the stay on the PDMA (such as blocking that decision—a move Farry says is unlikely), or creating policy guidelines. "Whether Congress does that through legislation or oversight and guidance, it has lots of tools at its disposal," he says.
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Indeed, Susan Winckler, vice president of policy and communications for the American Pharmacists Association (APhA), testified that while APhA supports advanced technologies and other ways to combat drug counterfeiting, its support is tempered by the need to minimize the impact on patients and recognize the reality that pharmacists have limited resources in terms of time and money. "Any anticounterfeit initiatives must include assessments of both the costs and benefits," she told the subcommittee. "As Congress seeks to close gaps in our system, it must assess the impact any proposed solutions might have on pharmacists and our ability to serve patients."
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| Douglas Farry |
Several speakers indicated the need for coordination among various states' current and forthcoming drug-pedigree laws, as well as the development of RFID standards. The latter continues to be a concern of many stakeholders, particularly pharmaceutical companies and the FDA. Joseph Pearson, business development manager at Texas Instruments, an RFID tag and chipmaker and one of Northern Apex-RFID's business partners, says the creation of a single item-level standard for the pharmaceutical industry would be a driving factor in RFID's mass adoption in that industry, as would the passage of legislation requiring the use of RFID technology to track drugs in the supply chain.
"The hearings represent the need for congressional legislation to provide the mandate directive that the FDA is looking for," says Pearson, who did not attend the hearings, but spoke with several who did, "so they can provide the rules to implement RFID in the industry."
It is unclear where the subcommittee's hearings will lead, but Farry says Congress has numerous options at its disposal, including acting on the FDA's decision to lift the stay on the PDMA (such as blocking that decision—a move Farry says is unlikely), or creating policy guidelines. "Whether Congress does that through legislation or oversight and guidance, it has lots of tools at its disposal," he says.
