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U.S. Department of Health and Human Services

Drugs

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Counterfeit Drug Task Force Report October 2003 - THE COUNTERFEIT DRUG TASK FORCE

A. Purpose of the Task Force

On July 16, 2003, Commissioner of Food and Drugs Mark McClellan, M.D., Ph.D., formed an internal FDA Counterfeit Drug Task Force to develop recommendations for steps FDA, other government agencies, and the private sector can take to minimize the risks to the public from counterfeit drugs and biologics (hereinafter, all references to “drugs” refers to both drugs and biologics) getting into the U.S. drug distribution system. This initiative is designed to enhance the existing safeguards that are in place to protect the nation’s drug supply from counterfeit drugs.

Although FDA believes that domestic counterfeiting is not widespread, 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.

Counterfeit drugs pose significant public health and safety concerns. They may contain only inactive ingredients, incorrect ingredients, improper dosages, sub-potent or super-potent ingredients, or be contaminated. As a result, patients may be put at risk for serious adverse health consequences. For example, Procrit, a drug used by cancer and AIDS patients, was recently counterfeited and the drug was replaced with nonsterile tap water, which could have caused a severe infection of the bloodstream. In another recent counterfeiting incident, white tablets with “aspirin” imprinted on them replaced Zyprexa, a drug used for schizophrenia and acute bipolar disorder. This could have been particularly dangerous for patients who are aspirin-sensitive or aspirin-allergic or who have bleeding disorders. In addition, patients no longer received appropriate treatment for their illness. Counterfeiters also have been known to switch lower-strength drug for higher strength drug. As a result, patients receive lower than expected doses of drug, leading to ineffective treatment and therapeutic failure.

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. For example, in South-East Asian countries approximately 10% of drugs on the market are believed to be counterfeit. In China, authorities believe that for some drugs, counterfeits account for 50% of the product on the market. It is reported that in underdeveloped countries such as Argentina, Colombia, and Mexico, up to 40% of manufactured pharmaceuticals may be counterfeit.

B. Development of the Interim Report

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

As part of this effort, the Task Force has met with several government agencies, such as the Secret Service, U.S. Customs and Border Protection, the Bureau of Engraving and Printing, and the Department of Justice, as well as various individual private sector stakeholders. The Task Force has also reviewed reports prepared by, or on behalf of, federal and state governments, and heard from the public, including such stakeholders as pharmaceutical manufacturers, wholesale distributors, pharmacy associations, consumer groups, academicians, independent consultants, and manufacturers of anti-counterfeiting measures. As described in more detail below, the Task Force intends to continue these interactions before developing its final report.

Based on what it has heard to date, the Task Force believes that the most constructive approach to addressing the problem of counterfeit drugs lies in identifying vulnerabilities in the drug distribution system and addressing those vulnerabilities with a multi-pronged approach. So far, the Task Force has found considerable consensus about these vulnerabilities, as well as new opportunities to address them. The Task Force intends to build on these ideas to identify a set of broadly supported initiatives to improve the security of the U.S. drug supply.

C. What the Interim Report Contains

This interim report contains a series of ideas and potential options developed by the Task Force for consideration in each of the following areas: technology, regulatory requirements and secure business practices, alert systems, education and public awareness, and international issues. The potential options are in the form of potential actions that, if taken, may prevent the introduction of, and help to quickly identify, counterfeit drugs in the U.S. drug distribution system. These options do not represent the recommendations of the Task Force; rather, they are included in this report to stimulate further discussion and critiques, and to support the development of clear proposals that are likely to succeed. Many of the options discussed complement each other and are not mutually exclusive.

In its research and exploration of ways to address counterfeit drugs, the Task Force has been sensitive to the rising cost of drugs and that its efforts should not impose additional costs that could be borne by consumers nor impede access to less expensive, lawfully obtained drugs. In fact, this interim report includes potential options that may bring about cost savings to entities in the U.S. distribution system, which could reduce drug costs while at the same time reducing the likelihood that U.S. consumers would receive a counterfeit product.

Additionally, Section IV of this interim report contains a series of questions highlighting areas where the Task Force wishes to obtain further information to help inform its final report.

D. Development of the Final Report

The Task Force plans to continue gathering information from individual stakeholders and members of the public as it prepares its final report which is scheduled for release in January 2004. As part of this effort, the Task Force will hold a public meeting and technology forum on October 15, 2003, during which the Task Force will hear testimony from the public on the problem of counterfeit drugs and will learn more about specific anti-counterfeiting technologies. See the counterfeit drug initiative web page at www.fda.gov for more information and a copy of the notice announcing the meeting. The questions in this report supplement the questions published in the notice.

The Task Force recognizes that the options presented in this report are based on what it has heard and reviewed to date, and looks forward to receiving comments and information that will provide further basis for the final report and recommendations of the Task Force.

E. Goals of the Initiative

In the final report, the Task Force plans to issue recommendations that will ensure that the U.S. drug distribution system continues to be the safest, most secure system in the world. Features of the system might include:

  • the use of cost-effective technologies, including many new and emerging technologies, to authenticate and track drugs from the point of manufacture to the point of dispensing to deter and detect the introduction of counterfeit drugs;
  • exercise of a high level of diligence by all purchasers to ensure that drug products are authentic, in accordance with industry standards and secure business practices;
  • a regulatory scheme that minimizes the burdens placed on each participant in the system; and
  • well-informed stakeholders and consumers.