Drug Task Force Update: FDA Is Paving the Way for Widespread Electronic Pedigree Implementation

By Eric Van Osten

The FDA's Counterfeit Drug Task Force began its busy year by holding a public workshop in Bethesda, MD, in early February. The event was designed to bring together major players who would help advance the Task Force's agenda of having widespread adoption of electronic track-and-trace to create an e-pedigree in place by 2007 to combat the growing problem of counterfeit drugs and drug diversion. Many companies voiced that they wanted the FDA to create a national standard to resolve the issue of what tools to use for authentication, promoting RFID as the best option.

After collecting, reviewing, and organizing the information that was exchanged at this meeting in June, the FDA announced new measures to protect Americans from counterfeit drugs. Among these measures, the FDA said it would fully implement regulations related to the Prescription Drug Marketing Act (PDMA) of 1987, requiring drug distributors to provide documentation of the chain of custody of drug products (pedigree) throughout the distribution system. It suggested that RFID would be useful for electronic pedigree-enabling capabilities. A deadline of 2007 to prioritize its pedigree-related enforcement resources was reinforced in the announcement.

Also released in June was the Draft Compliance Policy Guide, whose purpose was to state how the FDA intended to prioritize its enforcement efforts regarding the pedigree requirements. It defined "drug pedigree" as: "a statement of origin that identifies each prior sale, purchase, or trade of a drug, including the date of those transactions and the names and addresses of all parties to them." The Policy Guide established that under this requirement, "each person who is engaged in the wholesale distribution of a prescription drug in interstate commerce, who is not the manufacturer or an authorized distributor of record for that drug, must provide to the person who receives the drug a pedigree for that drug. The PDMA states that an authorized distributor of record is a wholesaler that has an 'ongoing relationship' with a manufacturer to distribute that manufacturer's drug." It listed criteria to look for to indicate which drugs are the most susceptible to counterfeit and diversion.

Future Task Force provisions

Looking toward the future, Counterfeit Drug Task Force member Dr. Ilisa Bernstein says that the FDA will be finalizing this guidance, enforcing implementation regulations to the PDMA by the 2007 deadline, as well as releasing a question-and-answer guidance that will focus on PDMA implementation. Two provisions will go into effect.

The first provision is to give greater clarity to who is and who is not an authorized distributor of record. Under the law, everyone involved in wholesale distribution will have to pass a pedigree (except manufacturers and authorized distributors of records who are exempt). An authorized distributor of record is someone who has an ongoing relationship with a manufacturer, and now "ongoing relationship" has a definition, which is the provision that was stayed, explains Bernstein. "You have to have a written agreement between the wholesaler and the manufacturer."

The other provision states what should go into a pedigree. The specific regulation talks about the dosage, container size, name of the drug, lot number or control number, name of the business and address, and date of all previous transactions. Bernstein says: "Relative to RFID, in our early report, we called for mass serialization of each individual package so that each package has its own unique number. People are still trying to figure out what that number is. So, one of the concerns that was brought to our attention was whether or not the National Drug Code number should be included in the unique identifying number [in the RFID tag or label]. We specifically addressed this and said in the report that the NDC number can be included, but that with RFID there are privacy issues that need to be addressed. So, if an NDC number is to be used, it should be encrypted in some way. Alternately, the number on the tag can be linked back to the NDC number because you're always linking back to some database, so that's where the NDC number could be stored so that it doesn't need to be part of the unique identifying number and privacy concerns aren't raised."

Bernstein reiterates the FDA's support for using RFID to provide e-pedigree. She states: "The FDA still believes, although the supply chains didn't achieve widespread use of electronic pedigree by 2007, that RFID is the most promising way to get you to widespread electronic pedigree. We are continuing to work with manufacturers, wholesalers, pharmacies, standards groups, and anyone else interested, to keep this moving. We're hoping that once the implementation comes around and more pedigrees are passed, that this will drive electronic pedigrees to be used more because people don't want paper flying around. The momentum will grow because of it."

Ilisa B.G. Bernstein, Pharm.D., J.D., Director of Pharmacy Affairs, Office of the Commissioner, U.S. Food and Drug Administration is on the FDA's Counterfeit Drug Task Force and has been working on this issue since the Task Force was created in 2003. Please visit the FDA online at www.fda.gov.