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U.S. Congressmen Seek to Specify a Track-and-Trace Technology for Drugs

At a House Committee on Energy and Commerce meeting, Reps Steve Buyer and Jim Matheson questioned the FDA and sought to gain support for HR 5839, which would require the agency to stipulate the technology to be used for a nationwide pedigree system.
By Claire Swedberg
In May 2007, the U.S. Senate passed a bill that included an amendment to the Safe Internet Pharmacy Act of 2007, calling for drug authentication technologies to help improve the safety of pharmaceuticals sold on the Internet (see U.S. Senate Bill Proposes Technology to Authenticate Drugs). The Safe Internet Pharmacy Act of 2007, however, was not passed by the Committee on Health, Education, Labor and Pensions and, thus, never made it to the Senate floor for consideration.

Last month, California extended the deadline for an e-pedigree system in its state (see All Eyes on FDA for Drug Pedigree) from 2009 to 2011, because the pharmaceutical industry indicated it would not be able to meet the earlier deadline.

At today's hearing, Buyer inquired about FDA support of a unified pedigree system, to which Bernstein responded that "a pedigree system provides transparency and accountability through the supply chain. That helps not only ensure [consumers receive] a safe product, but allows regulators to trace back through the supply chain." The FDA, she added, supports one uniform national standard but does not specify a specific track-and-trace standard, nor does it recommend a specific technology.

Inquiring whether technology had evolved enough to provide affordable pedigree solutions, Matheson asked, "Where is the technology now?" To this, Bernstein replied that "There has been tremendous progress on technology and standards" in the past four years.

A spokesperson for Buyer, who asked not to be named, said the congressman was concerned about the selling of pharmaceuticals via the Internet—one way in which counterfeit drugs may be entering the country from international markets. By requiring that drug manufacturers follow a standardized track-and-trace method, the spokesperson indicated, that problem could be alleviated.

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