FDA Announces Workshop to Promote Adoption of New Technology to Protect Patients from Counterfeit Drugs

January 9, 2006, The Food and Drug Administration (FDA) will hold a public workshop and vendor display on the use of radio-frequency identification (RFID) to combat counterfeit drugs. The meeting will be held on February 8 and 9, 2006, from 9:00 a.m. to 5:00 p.m. at the Holiday Inn Select Bethesda, 8120 Wisconsin Ave, Bethesda, Maryland.

“Drug counterfeiting is a worldwide problem and the growing sophistication of those who make their trade in this illegal business should be a concern to all of us,” said Deputy Commissioner for Medical and Scientific Affairs Scott Gottlieb, MD. “Despite this widespread activity, the United States has a very safe prescription drug supply and FDA is working hard to keep it that way. FDA believes meetings like this are essential to foster and cultivate the necessary cooperation to continue to keep our drugs safe.”

RFID offers the most promising technology to protect patients from counterfeit drugs because it could potentially provide reliable electronic records (“e-pedigrees”) that track prescription drugs from the manufacturer to the pharmacist. RFID also could provide for rapid location and distribution of drugs in case of national emergencies, such as in the event of a pandemic influenza situation.

Successful adoption of electronic track and trace technologies like RFID will require unusually high levels of cooperation among all stakeholders in the manufacture and distribution of medical products. Without cooperation among stakeholders, the full promise of RFID cannot be realized. While investments in some RFID technology may well make sense for some individual companies, the net benefits that all stakeholders will enjoy from RFID will be maximized if independent organizations adopt common standards and compatible approaches.

The goals of the meeting are to:

(1) Identify incentives and obstacles for widespread adoption of RFID throughout the United States drug supply chain, and to discuss ways of overcoming any impediments;

(2) Solicit comment on the implementation of the pedigree requirements of the Prescription Drug Marketing Act (PDMA) and the use of e-pedigree;

(3) Learn about the state of technology development related to electronic “track and trace” and e-pedigree technology solutions.

FDA will accept written comments on the RFID, PDMA, and e-pedigree issues until February 24, 2006. Comments may be submitted electronically at http://www.fda.gov/dockets/ecomments or mailed to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD, 20852. All comments should be identified with Docket Number 2005N-0510, Anti-Counterfeit Drug Initiative Workshop and Vendor Display (Notice). Meeting registration information can be found at http://www.fda.gov/RFIDmeeting.html.

Contact Information

Rae Jones

Food and Drug Administration (FDA)

Contact via E-mail