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Pharma Groups Respond to FDA RFID Report
Although eager to adopt the technology, the drug industry says obstacles still hinder widespread implementation.
By Beth Bacheldor
June 20, 2006—Pharmaceutical industry associations have thrown their support behind the recently released U.S. Food and Drug Administration's report on RFID's use in the pharmaceutical industry.
The June 9 report, "FDA Counterfeit Drug Task Force Report: 2006 Update," contains high-level recommendations for building a more secure and safe pharmaceutical industry supply chain (see FDA Issues New 'Counterfeit Drug Task Force' Report). The task force consists of senior staff from the agency's Office of the Commissioner (Office of Policy and Planning, Office of the Chief Counsel), Office of Regulatory Affairs, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research. For more than two years, the group has been investigating RFID technology and the concept of an electronic pedigree (e-pedigree), a procedure that records where a drug is manufactured and how it is distributed.
Industry associations such as the Pharmaceutical Research and Manufacturers of America (PhRMA), the American Pharmacists Association (APhA) and the Healthcare Distribution Management Association (HDMA) all agree that the task force's recommendations, endorsed by FDA Commissioner Andrew C. von Eschenbach, are a good step toward securing the pharmaceutical supply chain. In particular, the organizations praise the FDA's decision to end a temporary hold on regulations related to the Prescription Drug Marketing Act (PDMA) of 1987. That act requires drug distributors to document (via a pedigree, though not necessarily in electronic form) the chain of custody as drug products move through the distribution system. According to the FDA, the hold—initiated because there were concerns that pedigrees would have a negative impact on small wholesalers—will expire in December and not be extended.
The three groups also agree with the FDA's decision not to mandate RFID's use within the pharmaceutical industry. In its report, however, the FDA did recommend the industry "move quickly to implement this technology."
At this point, it's considered premature for the FDA to issue an RFID mandate because standards and technologies are still being worked out for item-level tagging, according to Alan Goldhammer, associate vice president of regulatory affairs for PhRMA, which represents pharmaceutical research and biotechnology companies. Case in point: The pharmaceutical industry, he notes, is still debating two differing RFID technologies—ultrahigh frequency (UHF) and high frequency (HF) (see RFID Vendors Unite to Promote UHF for Items and Study Says HF Rules for Pharma Items).
"If you look at what other industries are doing with mandates, particularly if they are in the consumer products industry, there are not quite the same issues," says Goldhammer. "It is very different if you are looking at putting RFID chips on blue jeans or DVDs, where you are just using RFID to identify the product in question."
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June 20, 2006—Pharmaceutical industry associations have thrown their support behind the recently released U.S. Food and Drug Administration's report on RFID's use in the pharmaceutical industry.
The June 9 report, "FDA Counterfeit Drug Task Force Report: 2006 Update," contains high-level recommendations for building a more secure and safe pharmaceutical industry supply chain (see FDA Issues New 'Counterfeit Drug Task Force' Report). The task force consists of senior staff from the agency's Office of the Commissioner (Office of Policy and Planning, Office of the Chief Counsel), Office of Regulatory Affairs, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research. For more than two years, the group has been investigating RFID technology and the concept of an electronic pedigree (e-pedigree), a procedure that records where a drug is manufactured and how it is distributed.
Industry associations such as the Pharmaceutical Research and Manufacturers of America (PhRMA), the American Pharmacists Association (APhA) and the Healthcare Distribution Management Association (HDMA) all agree that the task force's recommendations, endorsed by FDA Commissioner Andrew C. von Eschenbach, are a good step toward securing the pharmaceutical supply chain. In particular, the organizations praise the FDA's decision to end a temporary hold on regulations related to the Prescription Drug Marketing Act (PDMA) of 1987. That act requires drug distributors to document (via a pedigree, though not necessarily in electronic form) the chain of custody as drug products move through the distribution system. According to the FDA, the hold—initiated because there were concerns that pedigrees would have a negative impact on small wholesalers—will expire in December and not be extended.
The three groups also agree with the FDA's decision not to mandate RFID's use within the pharmaceutical industry. In its report, however, the FDA did recommend the industry "move quickly to implement this technology."
At this point, it's considered premature for the FDA to issue an RFID mandate because standards and technologies are still being worked out for item-level tagging, according to Alan Goldhammer, associate vice president of regulatory affairs for PhRMA, which represents pharmaceutical research and biotechnology companies. Case in point: The pharmaceutical industry, he notes, is still debating two differing RFID technologies—ultrahigh frequency (UHF) and high frequency (HF) (see RFID Vendors Unite to Promote UHF for Items and Study Says HF Rules for Pharma Items).
"If you look at what other industries are doing with mandates, particularly if they are in the consumer products industry, there are not quite the same issues," says Goldhammer. "It is very different if you are looking at putting RFID chips on blue jeans or DVDs, where you are just using RFID to identify the product in question."
