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FDA Proposes Bar Codes for Drug Authenticity

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FDA Anti-Counterfeiting Task Force Interim Report Focuses on High-Tech Weapons and Other Promising New Counter Measures

Public Meeting Announced

The Food and Drug Administration’s Counterfeit Drug Task Force today issued its interim report containing 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 (i.e., drugs which, or the container or labeling of which, is purported to be something that it isn’t). The task force’s final report is due in early 2004.

The potential options contained in the interim report are premised on three interim conclusions reached by the task force:

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. It could also be less costly, because a ‘one-size-fits-all’ approach is unlikely to work for all parts of the complex prescription drug supply system.
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.
3. Because many of these promising ideas have not been fully developed, the task force believes that an opportunity for broad public comment is essential to guide its further work.

"We know that the drugs available in the United States are among the safest in the world, but we still must remain on our guard against those who would exploit patients by selling counterfeit drugs instead," Health and Human Secretary Tommy G. Thompson said. "This task force's interim report brings us closer to a comprehensive strategy to better prevent drug counterfeiting and to quickly catch and stop those who attempt it."

“FDA’s task force is developing innovative approaches as never before on the significant and growing problem of counterfeit drugs,” said Mark B. McClellan, M.D., Ph.D., Commissioner of Food and Drugs. “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.”

Commissioner McClellan established the task force in July 2003 as part of FDA's heightened battle against counterfeit drugs. Commissioner McClellan 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.

With these goals in mind, the interim report contains a series of potential options for consideration in each of the following areas:

• Technology;
• Regulatory requirements and secure business practices;
• Rapid alert and response systems;
• Education and public awareness; and
• International collaboration.

Moreover, the potential options discussed in the interim report are based on reports the task force reviewed and what the task force heard from other governmental agencies, individual private stakeholders and consumers, including the U.S. Secret Service, the Bureau of Engraving and Printing, state governments, drug manufacturers, wholesale distributors, pharmacy associations, academics, independent consultants and manufacturers of anti-counterfeiting technology.

The interim report emphasizes that the potential options outlined are designed to address the specific problem of keeping America’s drug supply secure against counterfeit drugs. This is not the same problem as the distinct risks posed by unapproved drugs 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.

TECHNOLOGY

The task force spoke with many organizations and individuals who believe anti-counterfeiting technologies should be adopted to enhance the nation’s ability to reduce the risk of counterfeit drugs entering the distribution chain and reaching the consumer. “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.

The task force learned that both of these technologies are becoming more sophisticated, reliable, and inexpensive. However, a combination of technologies which change over time to stay ahead of the skills of counterfeiters is likely to be optimal, because there is no single “magic bullet,” and neither type of technology yet has a proven track record or is ready for widespread use.

REGULATORY REQUIREMENTS AND SECURE BUSINESS PRACTICES

There are many entities involved in the U.S. drug distribution system. The task force heard 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:

• 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; and
• 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:

• enhancing 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; and
• enhancing FDA's internal processes for responding to, and investigating reports of suspected counterfeit drugs.

EDUCATION AND PUBLIC AWARENESS ISSUES

The task force learned that there is a significant need to increase awareness and education of stakeholders, including the public, concerning counterfeit drugs. The following options are included 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 healthcare 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 foreign stakeholders to better coordinate their anti-counterfeiting efforts. Options that that 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; and
• 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.

NEXT STEPS

The task force will continue gathering comments and other information from individual stakeholders and members of the public as it prepares its final report for release in early 2004. As part of this effort the task force will hold a public meeting and new 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.

The FDA Counterfeit Drug Task Force Interim Report, additional information on the task force and public meeting, including how and where to submit comments and responses to the questions in the report, is available online at www.fda.gov/oc/initiatives/counterfeit/. Interested persons may submit written or electronic comments to FDA by November 3, 2003.