Counterfeit Drugs and the FDA

Last week, Randall W. Lutter, Associate Commissioner for Policy and Planning at the FDA testified before the Subcommittee on Criminal Justice, Drug Policy, and Human Resources Committee on Government Reform in the House.  This, by the way, is the same committee that Dr. Janet Woodcock testified before in May on RU-486 – testimony that the FDA never posted to their site.  Dr. Lutter’s testimony involved the FDA’s efforts aimed at preventing counterfeiting.

He stated that while the number of counterfeiting instances remains low, there has nevertheless been an increase.  "In fiscal year (FY) 2004, FDA’s Office of Criminal Investigations (OCI) initiated 58 counterfeit drug cases, a significant increase from the 30 cases initiated in FY 2003 and from an average of less than 10 cases per year in the 4 years before 2001.   Although the number of counterfeit drug cases opened by OCI in FY 2005 dropped to 32, preliminary numbers of such cases opened at this point in FY 2006 suggests that there will be an increase in line with the number of cases opened in FY 2004."   His testimony included an appendix with specific details.

He outlined the recommendations that the FDA’s panel on this topic had outlined in 2004 which largely appear to rely on emerging technologies to establish an electronic pedigree for products:

• Widespread use of electronic track and trace technology would help secure the integrity of the drug supply chain by providing an accurate drug “pedigree,” which is a record of the chain of custody of the product as it moves through the supply chain from manufacturer to pharmacy;
• Radio Frequency Identification (RFID) is a promising technology as a means to achieve electronic pedigree (e-pedigree);
• Widespread adoption and use of electronic track and trace technology would be feasible by 2007; and
• The effective date of certain regulations related to the implementation of the Prescription Drug Marketing Act (PDMA) should be delayed until December 1, 2006, in order to give stakeholders in the drug supply chain time to focus on implementing widespread use of e-pedigree.

And, accordingly, he laid out the progress stated in the 2005 report:

• Stakeholders had made significant progress in developing and implementing RFID  technology during the previous year;
• FDA was encouraged by the progress stakeholders, standard-setting bodies, and software and hardware companies had made toward implementing an e-pedigree for drug products and that we were optimistic that progress would continue in an expeditious manner toward meeting a 2007 goal of widespread use of e-pedigree across the drug supply chain; 
• If it appeared that the 2007 goal would not be met, FDA planned to consider options for implementing the provisions of the PDMA rulemaking that are the subject of the stay; and
• FDA would identify what we could do to address obstacles to the widespread adoption of RFID.

Progress in this area is bound to be incremental.  The issue of counterfeiting is certainly serious, but the efforts do lead to an important policy question.  If the FDA becomes proficient at detecting counterfeit drugs, does that ease concern regarding the importation of drugs, since a key foundation for opponents to importation is that the drugs are not safe?