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solution than incomplete and costly paper pedigrees is possible within the next severalyears. A detailed discussion of the comments is in Appendix B.

3) Discussion:

FDA has worked closely with affected parties to identify and resolve concerns relatedto the implementation of the pedigree requirements of the PDMA. Through the variouspublic comment opportunities over the years, the agency has heard mixed reviewsabout the value, utility, and difficulty of implementing a paper pedigree that identifieseach prior sale, purchase, or trade of such drug. The comments received in responseto questions raised in the Interim Report confirm that these concerns continue.

FDA is encouraged by the enthusiasm and interest that stakeholders in the U.S. drugsupply chain have expressed toward the adoption of sophisticated track and tracetechnologies that are more reliable than paper pedigrees. As discussed above, thereappears to be movement by industry toward implementation of electronic track and

trace capability in 2007. When this is in place, RFID should be able to function as ade

facto electronic pedigree that follows the product from the place of manufacturerthrough the U.S. drug supply chain to the final dispenser. If developed properly, thiselectronic pedigree could be used to meet the statutory requirement in 21 U.S.C. 353(e)(1)(A) to provide a pedigree under certain circumstances.

In the interim, until the electronic pedigree is in widespread use, voluntary adoption ofmulti-layer strategies and measures discussed in this report would reduce thelikelihood that counterfeit drugs will be introduced into the U.S. drug distributionsystem. These measures, combined with RFID technology, can help provide effectivelong-term protections that will minimize the number of counterfeit drug products in theU.S. distribution system.

As discussed in a notice published in the Federal Register in conjunction with thepublication of this report, FDA plans to continue to stay the of implementation of 21CFR 203.3(u) and 203.50. However, the agency intends to continue to reassessthe stay of implementation onan annual basis. The agency will monitor closelywhether progress toward the implementation of electronic pedigrees continues at therapid pace evident in this task force analysis. Our plan to reassess the stay annuallyis part of the agency's strong commitment to see that effective product tracing isimplemented as quickly as possible. The agency also encourages wholesalers toprovide pedigree information that documents the prior history of a drug product,particularly for drugs most likely to be counterfeited, even when the passing of such apedigree is not required by the Act. The suggestion from the comments that there bea one-forward, one-back pedigree for high-risk drugs in the interim, until an electronicpedigree is uniformly adopted, may have merit. However, FDA believes that Congresswould have to amend section 503(e) of the Act if such a system is to become arequirement.

15

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25

For government efforts against counterfeit drugs to be successful,drug producers, distributors, and dispensers will have to takeeffective actions to secure their business practices.

Efforts by stakeholders to develop the secure business practices listed

above would help protect the public health and diminish counterfeiting; FDA plans to work with individual stakeholders and groups representing

stakeholders, as necessary and appropriate, to continue to develop, makepublicly available, and widely disseminate secure business practices;

Good security practices include designation of an individual or team,reporting directly to the organizations senior management, to coordinatethe security and anti-counterfeiting activities for the organization;

FDA supports efforts by pharmaceutical manufacturers, wholesalers, andretailers to secure their physical facilities against counterfeit drugs. FDAplans to issue guidance on physical site security that applies toparticipants in the U.S. drug distribution system.

FDA plans to make its oversight over re-packagers of drugs a higherpriority. FDA expects to increase the frequency with which it inspects re-packagers whose operations are found to be at increased risk for theintroduction of counterfeit drugs. The increase in frequency will be basedon the degree of risk, as determined by applying to re-packagingoperations the risk based model FDA is developing for prioritizinginspections of drug manufacturing sites.

6. FDAS RAPID RESPONSE TO REPORTS OF SUSPECT

COUNTERFEIT DRUGS STREAMLINED

1) What FDA sought comment on:

Enhancing FDAs internal processes for responding to andinvestigating reports of suspected counterfeit products

2) What the Comments Said:

The comments unanimously supported any efforts by the agency to rapidlyrespond to reports of suspect counterfeit drugs.

3) Discussion:

FDA takes reports of suspect counterfeit products very seriously. The agency isproud of its investigative tools and talents and its quick response to the publichealth needs when a counterfeit has been reported and has been confirmed. Toimprove this process, the agency evaluated its policies and procedures forresponding to reports of counterfeit drugs to determine if FDAs response could

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