Counterfeit Drugs: FDA Suggests New Counter Measures

Mark B. McClellan, MD, PhD, Commissioner of Food and Drugs, commented on issuance of the report, “The potential options we are announcing today start us on the path to a 21st-century system that can better protect consumers against this emerging public health threat. As we develop these new approaches, FDA will continue to work hard to prevent counterfeit drugs from entering our drug supply, and to use the full force of the law against counterfeiters who would risk the health of the public for profit.”

Task Force Goals

The Task Force, established in July 2003, was specifically charged with developing recommendations for achieving four goals: 1) preventing the introduction of counterfeit drugs into the U.S. market; 2) facilitating the identification of counterfeit drugs; 3) minimizing the risk and exposure of consumers to counterfeit drugs; and 4) avoiding the addition of unnecessary costs on the prescription drug distribution system, or unnecessary restrictions on lower-cost sources of drugs.

With these goals in mind, the interim report contains a series of potential options for consideration in the areas of technology, regulatory requirements and secure business practices, rapid alert and response systems, public education and international collaboration.

Technology

“Authentication” and “track and trace” are two promising types of anti-counterfeiting technologies that came to light. Authentication technologies to assure that the drug is the real thing fall into three general groups: overt, covert and forensic. Track and trace technologies to help make sure that a product that finds its way to a consumer is a safe and effective drug include radio-frequency identification, and barcodes.

Regulatory Requirement and Secure Business Practices

The Task Force learned that the state requirements for licensure of wholesale distributors need to be updated and that the business practices among the entities involved in the U.S. drug distribution chain are insufficient and do not adequately protect the distribution system from the modern threat of counterfeit drugs. Options for establishing new and enhancing currently established secure business practices and regulatory requirements to affect the ability to deter and detect counterfeit drugs include: 1) developing a set of “best business practices” that would be voluntarily adopted by all manufacturers, wholesalers, re-packagers and pharmacies, as appropriate; 2) having all entities such as manufacturers, wholesalers, re-packagers and pharmacies designate an individual or team to coordinate security and anti-counterfeiting activities; 3) having all manufacturers timely share with the FDA market tracking and trending data and the analysis of these data for use as a means of identifying counterfeit or diverted product in the marketplace; and 4) continuing work with private and public sector partners, including the National Association of Boards of Pharmacy (NABP), to update model rules for licensure of wholesale distributors.

Rapid Alert and Response Systems

The Task Force identified opportunities to improve the systems used for timely reporting by, and alerting of, stakeholders and the public to the existence of counterfeit drugs. Options on how best to achieve this goal include: 1) enhancing the FDA's Medwatch Alert System; 2) creating a counterfeit alert network through existing or newly developed communication tools; and 3) enhancing the FDA's internal processes for responding to, and investigating reports of suspected counterfeit drugs.

Education and Public Awareness

The report's options for education and public awareness included suggestions that the public be made aware of how to identify and report counterfeit drugs. It also noted the need for educating agencies and industry to better coordinate efforts to contain counterfeit events.

International Collaboration

Options the Task Force is examining include developing global standards packaging and use of tracking technologies as well as fostering more cooperation between U.S. and international law enforcement agencies.

Conclusion

The FDA Counterfeit Drug Task Force Interim Report and information on how and where to submit comments and responses to the questions in the report, is available online at www.fda.gov/oc/initiatives/counterfeit/.

The FDA's Counterfeit Drug Task Force issued its interim report on October 2. It contains potential options for a multi-pronged approach to combat counterfeit drugs. In recent years, the FDA has seen an increase in the number and sophistication of efforts to introduce counterfeit drugs. The FDA noted at the time the report was issued that the problem of counterfeit drugs is being treated separately from the problem of unapproved and potentially unsafe drugs that are being imported via the Internet and other unregulated international channels. Under current law, those drugs are purchased outside of U.S. and foreign consumer protection systems, so they are “buyer beware” products that have traveled outside of the regulatory protections of the legal U.S. drug distribution system.

Final Report Due Soon

The Task Force's final report on ways to combat drug counterfeiting is due in early 2004. The potential options in the interim report were premised on three interim conclusions: 1) There is no single “magic bullet” against the growing number of sophisticated counterfeiters; rather, a multi-pronged strategy to secure the drug supply could be much more difficult for counterfeiters to overcome than any single method; 2) Although drug counterfeiters today are more sophisticated and better organized than ever before, there are many new technologies and approaches that have the potential to prevent and contain counterfeit drug threats; and 3) Because many of these promising ideas have not been fully developed, the Task Force will need to seek broad public comment to guide its further work.

Mark B. McClellan, MD, PhD, Commissioner of Food and Drugs, commented on issuance of the report, “The potential options we are announcing today start us on the path to a 21st-century system that can better protect consumers against this emerging public health threat. As we develop these new approaches, FDA will continue to work hard to prevent counterfeit drugs from entering our drug supply, and to use the full force of the law against counterfeiters who would risk the health of the public for profit.”

Task Force Goals

The Task Force, established in July 2003, was specifically charged with developing recommendations for achieving four goals: 1) preventing the introduction of counterfeit drugs into the U.S. market; 2) facilitating the identification of counterfeit drugs; 3) minimizing the risk and exposure of consumers to counterfeit drugs; and 4) avoiding the addition of unnecessary costs on the prescription drug distribution system, or unnecessary restrictions on lower-cost sources of drugs.

With these goals in mind, the interim report contains a series of potential options for consideration in the areas of technology, regulatory requirements and secure business practices, rapid alert and response systems, public education and international collaboration.

Technology

“Authentication” and “track and trace” are two promising types of anti-counterfeiting technologies that came to light. Authentication technologies to assure that the drug is the real thing fall into three general groups: overt, covert and forensic. Track and trace technologies to help make sure that a product that finds its way to a consumer is a safe and effective drug include radio-frequency identification, and barcodes.

Regulatory Requirement and Secure Business Practices

The Task Force learned that the state requirements for licensure of wholesale distributors need to be updated and that the business practices among the entities involved in the U.S. drug distribution chain are insufficient and do not adequately protect the distribution system from the modern threat of counterfeit drugs. Options for establishing new and enhancing currently established secure business practices and regulatory requirements to affect the ability to deter and detect counterfeit drugs include: 1) developing a set of “best business practices” that would be voluntarily adopted by all manufacturers, wholesalers, re-packagers and pharmacies, as appropriate; 2) having all entities such as manufacturers, wholesalers, re-packagers and pharmacies designate an individual or team to coordinate security and anti-counterfeiting activities; 3) having all manufacturers timely share with the FDA market tracking and trending data and the analysis of these data for use as a means of identifying counterfeit or diverted product in the marketplace; and 4) continuing work with private and public sector partners, including the National Association of Boards of Pharmacy (NABP), to update model rules for licensure of wholesale distributors.

Rapid Alert and Response Systems

The Task Force identified opportunities to improve the systems used for timely reporting by, and alerting of, stakeholders and the public to the existence of counterfeit drugs. Options on how best to achieve this goal include: 1) enhancing the FDA's Medwatch Alert System; 2) creating a counterfeit alert network through existing or newly developed communication tools; and 3) enhancing the FDA's internal processes for responding to, and investigating reports of suspected counterfeit drugs.

Education and Public Awareness

The report's options for education and public awareness included suggestions that the public be made aware of how to identify and report counterfeit drugs. It also noted the need for educating agencies and industry to better coordinate efforts to contain counterfeit events.

International Collaboration

Options the Task Force is examining include developing global standards packaging and use of tracking technologies as well as fostering more cooperation between U.S. and international law enforcement agencies.

Conclusion

The FDA Counterfeit Drug Task Force Interim Report and information on how and where to submit comments and responses to the questions in the report, is available online at www.fda.gov/oc/initiatives/counterfeit/.