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Newest Drug Pedigree Proposal Highlights RFID

A bill introduced in the US House of Representatives calls for the establishment of drug pedigree and identification standards, and directs federal officials to assess RFID's suitability for meeting them. The new legislation, however, appears to duplicate requirements set forth in the PDMA and the FDA Amendments Act of 2007.
Apr 29, 2008This article was originally published by RFID Update.

April 29, 2008—Yet more legislation has been introduced to require individual identification and pedigrees for prescription drugs in the US, and RFID technology is again highlighted as a potential solution. Last week congressmen Rep. Jim Matheson (D-UT) and Rep. Steve Buyer (R-IN) introduced H.R. 5839 Safeguarding America's Pharmaceuticals Act of 2008, a bill that calls for the federal government to develop drug identification and tracking systems to prevent counterfeiting. It specifically requires drug pedigrees and directs the Secretary of Health and Human Services to submit a feasibility report for using RFID, bar code, and other technologies.

The Safeguarding America's Pharmaceuticals Act of 2008 is new legislation and should not be confused with the Food and Drug Administration Amendments Act of 2007, a federal action that required the Food and Drug Administration (FDA) to establish national standards for drug identification and pedigrees (see FDA, EC Considering RFID for Drug Pedigrees).

"The Buyer-Matheson bill gives teeth to the FDAAA provision which called upon FDA to develop standards for an identifier and for a track and trace system," Rep. Matheson's communications director Alyson Heyrend said in a statement to RFID Update. "Under FDAAA, the FDA was given 30 months to develop the identifier standard; no such deadline was given for the track and trace standard. Our bill directs FDA to announce the standard by the end of March 2010 (which would be the 30 month deadline given in FDAAA), and within 18 months of the standard's announcement, manufacturers of high-risk drugs (those at high risk for counterfeiting or diversion) must place identifiers (which meet the FDA standard) on their high-risk products."

The FDA has required drug pedigrees since 1988 when the Prescription Drug Marketing Act (PDMA) became law, but the PDMA's pedigree requirements have repeatedly been stayed because of implementation concerns (see Injunction May Slow Momentum for RFID E-Pedigrees).

Rep. Buyer acknowledged the PDMA in his press release announcing H.R. 5839, which suggests the emergence of online pharmacies has rendered PDMA-mandated protections inadequate.

The bill would give the FDA authority to seize and destroy drugs at US ports of entry, establish new distributor licensing standards, require unique serial numbers for all prescription drugs, require pedigrees starting with the wholesale distributor, and require track-and-trace systems. It would also provide funding for small pharmacies to help them implement necessary technology.

"Additionally, the FDA is in charge of determining which drugs are at high risk for counterfeiting or diversion. Manufacturers must be given a year's notice before one of their drugs is placed on the list," Heyrend said.

The National Association of Chain Drug Stores (NACDS), which represents retail pharmacies, responded to H.R. 5839 by asking Congress to focus on efforts that would prevent counterfeit pharmaceuticals from entering the supply chain, rather than tracking them. In a press release, the association said: "We urge Congress to carefully examine all proposals and not prematurely mandate technologies that are still under development. Efforts to enhance the security of the drug supply chain must be feasible, practical, reliable, and cost-effective."

A NACDS spokesperson told RFID Update the organization was still studying the proposed legislation and could not comment on how it differs from previously established federal pedigree and identification requirements.

As overlapping federal efforts slowly work their way through the legislative process, states are creating their own drug pedigree and identification laws (for a summary, see this useful visual by the Healthcare Distribution Management Association). The NACDS recently helped block implementation of pedigree requirements in California, where there were concerns about industry readiness and the ability to ensure an adequate drug supply if the new regulations took effect (see California Not Ready for Drug Pedigrees -- Is RFID?).
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