News

Posted On: 11/16/2004

FDA Eases Enforcement of Firms Testing RFID

In what can only be seen as a wholesale endorsement of RFID as the key to the securing the nation’s future drug supply, FDA released guidelines aimed at easing the regulatory fears of pharmaceutical firms pursuing RFID applications. Looked at another way, the announcement could be seen as a death knell for both barcoding and paper-based product pedigrees.

Wasting no time, Pfizer, GlaxoSmithKline, and Purdue Pharma simultaneously announced initiatives to place RFID-enabled labels on individual units of their more popular drug products as soon as possible. (See related news story, "Pfizer, GSK and Purdue Begin RFID Tagging," also on this website.)

FDA said it had received many inquiries from industry regarding whether RFID feasibility studies and pilot programs would be in violation of regulatory requirements for labeling, electronic recordkeeping, and product quality. In response, the Agency says it will “exercise enforcement discretion” in a number of areas. Among the many parameters it set:

• There is no limit to the number of RFID tags or readers that may be used in industry studies.
  
• The drugs involved may be prescription or over-the-counter. Biologics or protein drugs, however, will be held to traditional rigid testing and development standards.
  
• RFID will be used only for inventory control, product tracking and tracing, shipping verification, and authentication of finished products.
  
• RFID tags are not to be used in lieu of current labeling control systems, or to transmit information to consumers or healthcare practitioners.

If a study meets all of the new parameters, the Agency promised not to initiate regulatory action related to any 21 CFR guidelines. The policy is to stand until December 31, 2007, FDA said.

“Bogus medication is a growing health threat,” said FDA acting commissioner Lester M. Crawford. The current measures are meant to show that FDA has “stepped up” its efforts to address that threat. The Agency also acknowledged that, down the line, RFID will help to reduce costs to consumers by enhancing inventory control and product recall efficiency. By focusing the industry’s efforts on RFID, the Agency said it hoped to discourage firms from diffusing resources through both paper-based and paperless efforts.

RFID’s gain is barcoding’s loss. “Barcoding will be around for a little while,” said Thomas McGinnis, director of pharmacy affairs, “but eventually RFID will replace it. In 10 or 20 years, we will see barcodes go away.”