FDA Sharpens Its RFID Initiative

The U.S. Food and Drug Administration is shifting its radio-frequency identification efforts into high gear with a new Compliance Policy Guide for implementing radio-frequency identification and an internal working group to monitor the adoption of RFID in the pharmaceutical industry. The policy guide, published this week, will create more opportunities for pilot programs that involve RFID tagging of bottles and other packaging materials and drugs that are a high risk for counterfeiting, said Dr. Paul Rudolf, senior adviser for medical and health policy at the Food and Drug Administration during a press conference Monday. Companies that sponsor RFID programs won't have to come to the agency on a case-by-case basis for permission; instead they will be able to turn to the guide for compliance regulations.

"The [guide] is the outgrowth of a series of questions that have been raised to the FDA about the use of RFID technology," Rudolf said. "For example, sponsors and participants of various RFID pilot studies have come to us asking whether we were concerned about the effects of electromagnetic energy on products, whether we considered RFID to be labeling, whether we believed that any good manufacturing practices were implicated by the use of RFID."

The agency has limited its policy to pharmaceutical drugs and excludes biologics, which are chemically synthesized products that are derived from living sources such as humans, animals, and microorganisms, said Rudolf. The exposure of biologics to electromagnetic energy can be problematic; therefore, companies piloting RFID on biologics packages will be reviewed on a case-by-case basis.

To further accelerate RFID standard-setting activities such as tag numbering, optimal frequency use, and database management, the new workgroup will monitor RFID adoption, identify regulatory issues, and develop processes for handling those issues. "The point of this is to further any counterfeiting reports that the FDA issued last year or early this year in which we describe a need for a number of new procedures to protect the drug supply against counterfeit drugs, and one of those was to encourage the development of RFID technology as a track-and-trace protection for pharmaceuticals," said William K. Hubbard, associate commissioner for policy and planning at the Food and Drug Administration.

Pharmaceutical companies are expecting RFID technology to become the standard for providing track-and-trace protection for drugs in the future, Hubbard said. Pfizer already announced its plans to put RFID tags on all bottles of Viagra intended for sale in the United States as early as 2005. Purdue Pharma also announced that it will be tagging bottles of OxyContin to make it easier to authenticate and track-and-trace pain medication.

The new policy guide is still under consideration and the agency is accepting public comments regarding revisions. The guidelines will go into effect upon publication in the Federal Register, which Rudolf said will take place in December 2007.