RFID: FDA Update

A few weeks ago FDA Associate Commissioner Randall Lutter, Ph.D spoke at the first NACDS/HDMA* Summit on the adoption of RFID technology in healthcare.

His comments included an update on the FDA initiative to implement electronic pedigrees for tracking the manufacture and sale of prescription drugs, which until now has been a voluntary initiative.

Lutter stated, "Supply chain stakeholders assured us that there would be considerable movement toward implementation of RFID and that widespread adoption could be done in 2007... Yet from our vantage point today, it appears a voluntary approach may not be enough... We are concerned that widespread adoption may not be realized by December 2006, when the PDMA stay expires."

He announced that the FDA Counterfeit Drug Task Force will hold a Public Workshop in January or February 2006 to discuss barriers to implementation and to assert the FDA's commitment to adoption of electronic pedigree technology.

Lutter said "In the coming weeks, we will put out an invitation for people to testify on these and other issues and we expect to publish more information about this meeting in the near future both in the Federal Register and posted on FDA’s website."

Stay tuned.

*NACDS - National Association of Chain Drug Stores
HDMA - Health Department Management Association

Sally Bacchetta - Freelance Writer
Freelance Writer
RFID