FDA counterfeit task force issues interim report
FDA counterfeit task force issues interim report
New technologies have potential to address threat
The Food and Drug Administration’s (FDA’s) Counterfeit Drug Task Force has issued its interim report outlining potential options for an approach to combat counterfeit drugs.
The task force says it has reached three interim conclusions regarding the counterfeiting issue:
• No single "magic bullet" against the growing number of sophisticated counterfeiters exists. Instead, a multipronged strategy to secure the drug supply could be much more difficult for counterfeiters to overcome. It also could be less costly than any single method, because a one-size-fits-all approach is unlikely to work for all parts of the complex prescription drug supply system.
• Drug counterfeiters today are more sophisticated and better organized than ever before. However, many new technologies and approaches are available that have the potential to prevent and contain counterfeit drug threats.
• Since many of these ideas have not been fully developed, the task force believes that an opportunity for broad public comment is essential to guide its ongoing research.
FDA commissioner Mark B. McClellan, MD, PhD, established the task force in July. He specifically charged the task force with developing recommendations for achieving four fundamental 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.
To reach these goals, the interim report breaks down a series of potential options that should be considered in each of the following areas:
• Technology. Many sources with knowledge about drug counterfeiting believe that technology can enhance the nation’s ability to reduce the risk of counterfeit drugs entering the distribution chain and reaching the consumer. Two promising types of anti-counterfeiting technologies mentioned are "authentication" and "track and trace." Authentication technologies fall into three general groups: overt, covert, and forensic. Track and trace include radio-frequency identification and bar codes.
The task force learned that both of these technologies are becoming more sophisticated, reliable, and inexpensive. However, a combination of technologies that change over time to stay ahead of the skills of counterfeiters is likely to be best. Neither type of technology yet has a proven track record or is ready for widespread use.
• Regulatory requirements and secure business practices. The task force discovered 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.
The task force has listed these options for establishing new and enhancing currently established secure business practices and regulatory requirements to affect the ability to deter and detect counterfeit drugs:
— developing a set of "best business practices" that would be voluntarily adopted by all manufacturers, wholesalers, repackagers, and pharmacies as appropriate;
— designating, by all entities such as manufacturers, wholesalers, repackagers, and pharmacies, an individual or team to coordinate security and anti-counterfeiting activities;
— timely sharing with FDA, by all manufacturers, of 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;
— continuing work with private and public sector partners, including the National Association of Boards of Pharmacy, 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:
— enhancing the FDA’s Medwatch Alert System for use as a tool to receive and disseminate timely information about counterfeit products, especially identification of suspect product;
— creating a counterfeit alert network through existing or newly developed communication tools;
— enhancing the FDA’s internal processes for responding to and investigating reports of suspected counterfeit drugs.
• Education and public awareness. The task force learned that there is a significant need to increase awareness and education of stakeholders, including the public, concerning counterfeit drugs. The task force lists the following options to do this in the interim report:
— increasing the efforts of the FDA, other governmental agencies, and appropriate private sector partners to educate consumers and health care professionals on how to reduce the risk of obtaining counterfeit drugs before an event occurs;
— educating consumers and health care professionals on how to identify counterfeit drugs (including how to recognize anti-counterfeiting technologies on packaging and labeling and what to do if they believe they have encountered suspect product);
— exploring ways of improving and coordinating agency and industry messages and efforts to address and contain a counterfeit event.
• International collaboration. The task force heard that the global nature of counterfeiting suggests that American stakeholders should consider working with their foreign counterparts to better coordinate their anti-counterfeiting efforts.
Options the task force is examining include:
— strengthening international cooperation in law enforcement efforts, identification of counterfeit products, use of anti-counterfeiting technologies, and education of stakeholders and consumers;
— developing global standards for a) the packaging of final dosage forms and active pharmaceutical ingredients; b) the use of tamper-evident packaging; c) product pedigrees; d) the use of anti-counterfeiting measures; and e) the use of track/trace technologies.
The task force plans to continue gathering comments and other information from individuals and members of the public. It planned a public meeting and new technology forum on Oct. 15 to hear testimony from the public on the problem of counterfeit drugs and to learn more about specific anti-counterfeiting technologies. The task force’s final report is due in early 2004.
The Food and Drug Administrations (FDAs) Counterfeit Drug Task Force has issued its interim report outlining potential options for an approach to combat counterfeit drugs.Subscribe Now for Access
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