Washington Letter: New Drug Pedigree Rules — A Paper Chase?

Oct. 16, 2006
FDA’s pedigree requirements are sparking debate among drug manufacturers. Among the sticking points: the definition of ADRs, as well as a proposal to base pedigree lists on past counterfeiting cases.

Come Dec. 1, 2006, drug manufacturers will have to meet new drug pedigree requirements, which will force nonauthorized drug distributors, including secondary wholesalers, to document the path that certain drugs have taken from the manufacturing plant, and all along the distribution chain. FDA is requiring a pedigree because drug manufacturers have been too slow to implement radio frequency identification (RFID) track and trace technology, which the Agency considers the "gold standard" for supply chain security.

Pfizer has been tagging some packages and cases of Viagra since December, and a few other drug companies are using RFID, pharma implementation of RFID simply isn’t happening across the board.

FDA has had the authority to require pedigrees since 1999 because of a provision in the Prescription Drug Marketing Act (PDMA). But the FDA had delayed implementing that provision to see whether there would be wide-scale industry use of RFID or perhaps some other electronic technology. Because that hasn’t happened, the Agency has released the “hold” on pedigree requirements.

At this point, it appears likely that pedigrees will take a paper, rather than electronic form. Tom McPhillips, vice president of the U.S. Trade Group for Pfizer, Inc., says paper pedigrees are vulnerable to falsification. But he believes they will still "aid in the diligence in supply chain transactions” pending comprehensive, interoperable technologies."

Gans of the APhA is less confident. He states, "A paper pedigree system could negatively impact the security of our drug distribution system by creating a false sense of security when the mere presence of a paper pedigree could be proof of little."

But pedigree requirements may force some manufacturers to rethink the list of "Authorized Distributors of Record" they keep, and the kind of product information that they pass along to those ADRs. They may decide to drop some wholesalers from those lists.

Non-ADRs will have to present a pedigree for each product they are delivering. That pedigree can take either paper or electronic form; but, at this point it seems most likely that it be paper. It must include the proprietary and established name of the drug; dosage; container size; number of containers; drug’s lot or control number(s); business name and address of all parties to each prior transaction, and the date of those prior transactions.

The FDA has not yet decided which drugs the pedigrees will be required for. Likely, the Agency will supply a list of drugs that have been counterfeited in the past. But some parties are pushing the Agency to require pedigrees for all drugs from all wholesalers, even the Cardinals, McKessons and AmerisourceBergens of the world. Mary Ann Wagner, senior vice president at the National Association of Chain Drug Stores, says the exemption for ADRs "may result in an unmanageable system."

Will “susceptible drug” lists shift counterfeiters’ focus?

Pfizer’s McPhillips also worries that FDA’s publishing a list of “susceptible” drugs to which the pedigree requirement would pertain would merely shift counterfeiters’ attention from past successes to future possibilities. “An approach that too narrowly focuses efforts and relies on the past can suggest to counterfeiters that other drugs that will be ‘fair game’ to try and counterfeit,” he explains.

However, Zena Kaufman, director of the Quality Center for Excellence at Abbott, thinks there is merit in the FDA providing such a list. So the manufacturing community has some differences of opinion here.

But drug manufacturers will have to address other issues as well. First, the FDA must decide within the next few months how manufacturers will make their ADR lists available to the public, and how frequently those lists will have to be updated. Even if the FDA sticks with its current plan to require only non-ADRs to pass along pedigrees, those non-ADRs may have to get the pedigree information from manufacturers, which they will not be obligated to provide.

John A. Gans, executive vice president of the American Pharmaceutical Association (APhA), which represents pharmacists, worries, "It is unlikely that a manufacturer or authorized distributor would voluntarily produce a pedigree for a drug product, especially after considering the time, manpower, and costs involved." If this scenario comes to fruition, pharmacies might have trouble getting some smaller-volume, niche drugs.

The FDA has not decided yet how manufacturers must make their ADR list available. There wasn’t anything on this specific issue in the draft Compliance Policy Guide the FDA issued in June. Anita T. Ducca, senior director, regulatory affairs and healthcare policy, Healthcare Distribution Management Association (HDMA) says, "There is a need for greater clarity regarding the FDA’s expectations of manufacturers and or how the Agency will enforce this requirement."

About the Author

Stephen Barlas reports on developments in Washington for newspapers and magazines. A freelance journalist since 1981, he has covered developments at FDA and within the industry for two decades.

About the Author

Stephen Barlas | Washington Correspondent