The U.S. Food and Drug Administration (FDA) announced new steps to strengthen existing protections against the growing problem of counterfeit drugs. The measures, which were recommended in a report by the agency’s Counterfeit Drug Task Force, emphasize certain regulatory actions and the use of new technologies for safeguarding the integrity of the U.S. drug supply. FDA officials believe that the prevalence of bogus drugs is low but said drug counterfeiters are becoming increasingly sophisticated. The FDA’s Office of Criminal Investigations opened 32 counterfeiting cases last fiscal year and 58 in fiscal 2004, compared with fewer than 10 cases a year five years earlier. Some of the most commonly counterfeited drugs are Viagra and Cialis for erectile dysfunction, the antipsychotic drug Zyprexa, Lamisil for nail fungus and Procrit, which is often used by cancer and AIDS patients to treat anemia, according to the FDA.

Among other new measures, FDA will implement regulations requiring drug distributors to provide documentation of the chain of custody of drug products — the so-called “pedigree” — throughout the distribution system. FDA had placed on hold certain regulatory provisions because of concerns raised at the time about the impact on small wholesalers. Most recently, in early 2004, FDA delayed the effective date of certain regulatory provisions regarding pedigrees to allow the industry time to adopt electronic technology (RFID) for tracking drugs through the supply chain. The FDA had expected this technology to be in widespread use in the drug supply chain by 2007, but it now appears that this won’t happen. The FDA felt that continuing the hold would perpetuate the current confusion and further allow opportunities for counterfeit and diversionary practices. FDA determined that it can no longer justify not implementing these regulations. Therefore, the hold, which will expire in December, will not be continued.

The FDA also announced that, during the next year, its enforcement of the pedigree regulations will focus on products most susceptible to counterfeiting and diversion. The FDA intends to announce in the Federal Register the availability of a draft compliance policy guide for public comment describing this enforcement approach. By providing guidance on the types of drugs that are currently of greatest concern to the FDA, the agency intends to give wholesale distributors a better idea on where and how to focus their initial energies to come into complete compliance with the regulations (21 CFR Part 203) for all the prescription drugs they distribute. The draft guidance clarifies how the FDA intends to prioritize its pedigree-related enforcement resources in 2007. The FDA may initiate regulatory action including criminal prosecution, for pedigree violations that do not meet the factors listed in the guidance.

A Task Force report recommends the widespread use of e-pedigrees using electronic track and trace technology, including RFID, would provide an electronic safety net for our nation’s drug supply. The report recommends that companies continue to work toward that goal, and that their implementation of RFID technology be used first on products most susceptible to counterfeiting and diversion.

Additional subjects discussed in the Task Force’s report include the following key issues related to electronic track-and-trace that are in need of resolution:

  • Technical aspects of the mass serialization of marketed drugs by assigning a unique identifier or serial number to each drug package as the initial step in development of track and trace technology.
  • Importance of a nationwide universal drug pedigree with uniform information in preference to state laws imposing different pedigree requirements.
  • Protection of consumer privacy to prevent unauthorized disclosure of information stored in RFID tags when RFID-tagged drug products are dispensed to consumers.
  • Consumer education about RFID and the labeling of RFID-tagged drug products, to disclose to consumers when they are receiving RFID-tagged products and to inform consumers of the benefits of RFID technology and how consumers’ privacy is being protected.
  • All Task Force Reports are posted on FDA’s Web here.

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