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In June 2006, the Food and Drug Administration's Counterfeit Drug Task Force released a new report on ways to curb the growing problem of counterfeit drugs. The report recommends measures that emphasize certain regulatory actions and the use of new technologies for safeguarding the integrity of the drug supply in the United States.
"The adoption of the FDA Counterfeit Drug Task Force's recommendations will further reduce the risk that counterfeit products will enter the U.S. drug distribution system and reach patients," says Acting FDA Commissioner Andrew C. von Eschenbach, M.D. "We must remain vigilant in our efforts to ensure our nation's drug supply is protected against an increasingly sophisticated criminal element engaging in a dangerous type of commerce."
Among the new measures, the FDA will fully implement regulations related to the Prescription Drug Marketing Act of 1987, which requires drug distributors to provide documentation of the chain of custody of drug products--the so-called "pedigree"--throughout the distribution system.
The FDA had placed certain regulatory provisions on hold because of concerns raised at the time about the impact on small wholesalers. Most recently, in early 2004, the FDA delayed the effective date of certain regulatory provisions regarding pedigrees to allow the industry time to adopt electronic technology for tracking drugs through the supply chain.
On the basis of information from drug supply stakeholders, the FDA had expected this technology to be in widespread use in the drug supply chain by 2007. But it now appears that these expectations will not be met.
Furthermore, concerns raised in the past regarding the impact on small wholesalers have not been repeated. In fact, the FDA was encouraged by most drug stakeholders to allow the hold to expire. Doing so also would provide clarity in the drug supply chain regarding who is and is not required to pass a pedigree. Continuing the hold would allow the current confusion to continue and to further allow opportunities for counterfeiting activity. The hold expires in December and will not be continued.
Consistent with recommendations of the Task Force, the FDA also announced that during 2007, its enforcement of the pedigree regulations will focus on products most susceptible to counterfeiting and diversion. The FDA intends to announce that the availability of a draft compliance policy guide for public comment describing this enforcement approach will be available in the Federal Register.
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 for all the prescription drugs they distribute. Under appropriate circumstances, the agency may initiate regulatory action, including criminal prosecution, for pedigree violations that do not meet the factors listed in the guidance.
The Task Force report also underlines the agency's belief that widespread use of electronic pedigrees (e-pedigrees) using electronic track and trace technology, including radio frequency identification (RFID), would provide an electronic safety net for our nation's drug supply. RFID places electromagnetic chips and tags containing a unique serial number onto cartons and individual drug products. This technology creates an e-pedigree for tracking the movement of the drug through the supply chain. The report recommends that stakeholders continue to work expeditiously toward this goal, and that their implementation of RFID technology be used first on products most susceptible to counterfeiting.
The new FDA report is largely based on the Task Force's recent findings in numerous contacts with stakeholders, including a February 2006 public workshop, a request for public comment, and monitoring of the latest technological developments.
This latest report is the third in a series of documents exploring ways to ensure the safety of the U.S. drug supply. The first report, issued in 2004, outlined the framework for protecting the public from counterfeit medicines. The second report, released last year, assessed the progress toward implementing the 2004 recommendations.
FDA Task Force Reports
www.fda.gov/counterfeit