FDA to Host Workshop on Anticounterfeiting Technologies

The FDA will hold a public workshop and vendor display next month on the use of radio-frequency identification (RFID) to combat counterfeit drugs.

The Feb. 8-9 workshop in Bethesda, Md., is intended to promote increased RFID use in the U.S. drug supply chain -- a goal that "will require unusually high levels of cooperation among all stakeholders in the manufacture and distribution of medical products," the FDA said in a Jan. 9 notice.

Better Communication Key

"FDA believes meetings like this are essential to foster and cultivate the necessary cooperation to continue to keep our drugs safe," said Scott Gottlieb, the agency's deputy commissioner for medical and scientific affairs.

The meeting will focus on several key goals, including:

Identifying incentives and obstacles for widespread adoption of RFID throughout the U.S. drug supply chain; Discussing strategies for overcoming impediments to RFID adoption; Soliciting comment on the implementation of the electronic pedigree requirements of the Prescription Drug Marketing Act; and Learning about the state of technology development related to electronic "track and trace" and electronic pedigree technology solutions.

The FDA is currently planning to implement an electronic pedigree system for drug products by 2007. However, PhRMA is urging industry to focus electronic security technologies on drug-dispensing sites because the association believes the proposed RFID-based electronic pedigree system is complex and unlikely to be implemented widely for five or more years.

FDA will accept written comments on the RFID, PDMA, and epedigree issues until Feb.24, 2006. Comments may be submitted electronically at http://www.fda.gov/dockets/ecomments (http://www.fda.gov/dockets/ecomments).

For more information about the meeting, go to http://www.fda.gov/RFIDmeeting.html (http://www.fda.gov/RFIDmeeting.html).