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U.S. Department of Health and Human Services


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Counterfeit Drug Task Report February 2004 Update - COMBATING COUNTERFEIT DRUGS

A. Purpose of the Anti-Counterfeiting Initiative

The actions described in this report are based on the work of an internal FDA Counterfeit Drug Task Force,1 which was formed in July 2003 by Commissioner of Food and Drugs Mark McClellan, M.D., Ph.D., with the goals of:

  • Preventing the introduction of counterfeit drugs and biologics into the U.S. drug distribution chain;
  • Facilitating the identification of counterfeit drugs and biologics;
  • Minimizing the risk and exposure of consumers to counterfeit drugs and biologics; and
  • Avoiding the addition of unnecessary costs to the prescription drug distribution system, or unnecessary restrictions on lower-cost sources of drugs.

B. Scope of the Problem

FDA believes that counterfeiting is not widespread within the system of manufacturing and distributing pharmaceuticals legally in the United States, as a result of an extensive system of federal and state regulatory oversight and steps to prevent counterfeiting undertaken by drug manufacturers, distributors, and pharmacies. However, the agency has recently seen an increase in counterfeiting activities as well as increased sophistication in the methods used to introduce finished dosage form counterfeits into the otherwise legitimate U.S. drug distribution system. FDA counterfeit drug investigations have increased to over 20 per year since 2000, after averaging only 5 per year through the late 1990's. (See Figure 1 -- Chart of FDA investigations) Increasingly, these investigations have involved well-organized criminal operations that seek to introduce finished drug products that may closely resemble legitimate drugs yet may contain only inactive ingredients, incorrect ingredients, improper dosages, sub-potent or super-potent ingredients, or be contaminated. Thus, drug counterfeiting poses real public health and safety concerns today, and may pose an even greater threat in the future if we fail to take preventative measures now. As counterfeiters continue to seek out new technologies to make deceptive products and introduce them into legitimate commerce, our systems for protecting patients must respond effectively.

linked to long description of chart called Counterfeit Drug Cases are Increasing
Fig. 1: FDA open investigations 1997-2003

Although exact prevalence rates in the U.S. are not known, outside the U.S. drug counterfeiting is known to be widespread and affect both developing and developed countries. In some countries more than half of the drug supply may consist of counterfeit drugs. For example, recent reports have detailed that more than 50% of anti-malarials in Africa are believed to be counterfeit. In virtually all countries, counterfeit drug operations have been uncovered in recent years.

C. What is in this Report

The body of this report contains a range of findings that have broad support from industry stakeholders and the public to identify and address the vulnerabilities in the U. S. drug distribution system to counterfeit drugs.

This report is based on the potential options discussed in the Task Force's Interim Report, the comments FDA received in response to that report, our internal discussions, and on information gathered and reviewed by the Task Force including:

  • Meetings with government agencies, manufacturers, wholesalers, retailers, professional and trade associations, standard-setting organizations, consumer groups, and manufacturers of anti-counterfeiting measures;
  • Reviewing reports prepared by, or on behalf of, federal and state governments;
  • Sponsoring a public meeting where 72 presentations were made
  • Sponsoring a technology forum which included 54 exhibits
  • Reviewing public comments to the anti-counterfeiting initiative docket
  • Site visits to manufacturing facilities, wholesale distribution centers, retailers, radio-frequency identification (RFID) laboratories and pilot facilities;
  • Attendance at stakeholder task force meetings and industry RFID feasibility study meetings
  • Meetings with academic and industry experts

Appendix A contains the Counterfeit Alert Network Co-sponsorship agreement. See www.fda.gov/oc/initiatives/counterfeit/archive.html for background information that was included in the Task Force's Interim Report (released on October 2, 2003) as well as a detailed discussion of the comments FDA received. Appendix B contains a more detailed discussion of the comments FDA received and considered in developing the final report.

The FDA is grateful for the input and universal support, not only with regard to the creation of the task force, but also with regard to the need for securing the nation's drug supply.

D. Securing our Nation's Drug Supply

To secure the U. S. drug supply chain, there are several areas that deserve attention, including the areas of technology, business practices, legislation, regulation, public awareness and education, creation of an alert network, and international cooperation.

 1The Task Force consists of senior agency staff from the Office of the Commissioner (Office of Policy and Planning, Office of External Affairs, and Office of the Chief Counsel), Office of Regulatory Affairs, the Center for Drug Evaluation and Research, and the Center for Biologics Evaluation and Research.