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HHS TAKES NEW STEPS TO PROTECT CONSUMERS FROM COUNTERFEIT DRUG THREATS

HHS Secretary Tommy G. Thompson today released a final report developed by the Food and Drug Administration (FDA) that highlights specific steps the agency is taking to keep the U.S. drug supply secure against increasingly sophisticated criminal efforts to introduce counterfeit drugs.

The report addresses growing concerns about the threat to consumers posed by counterfeit drugs. Though counterfeiting is not now widespread in the U.S. drug market, the FDA is investigating more cases of such activity, often involving well-organized criminal operations working to introduce finished drug products that resemble legitimate drugs but may contain only inactive ingredients, incorrect ingredients, improper doses or be otherwise contaminated.

“Americans must have confidence in their medications even as we face more sophisticated and better organized counterfeit operations,” HHS Secretary Thompson said. “This task force's report provides a clear roadmap to prevent drug counterfeiting and to quickly catch and stop those who attempt it. We will take the necessary steps to protect all Americans from those who would exploit and harm them by selling counterfeit drugs.”

“FDA will lead the way in taking the steps necessary to keep our nation’s drug supply safe and secure,” FDA Commissioner Mark McClellan, M.D., Ph.D., said. “This report shows how to achieve modern, comprehensive security protections for our drug supply that can keep pace with the increasingly sophisticated threats we face. FDA will not rest until we have strong protections in each link in the drug supply chain, and we intend to work with all of those involved in getting medicines to Americans legally and safely to make sure that Americans are protected.”

The comprehensive report highlights ways to assure that the nation’s drug distribution system protects Americans from counterfeit drugs. These measures address six critical areas:

• Securing the actual drug product and its packaging;
• Securing the movement of the product as it travels through the U.S. drug distribution chain;
• Enhancing regulatory oversight and enforcement;
• Increasing penalties for counterfeiters;
• Heightening vigilance and awareness of counterfeit drugs; and
• Increasing international collaboration.

The report was issued by an FDA task force, created in July 2003, to identify steps that the FDA, other government agencies and the private sector could take to minimize the risks to the public from counterfeit medications entering the nation’s drug distribution system. The task force met with and heard from security experts, federal and state law enforcement officials, technology developers, manufacturers, wholesalers, retailers, consumer groups, and the general public. In October 2003, the task force issued an interim report that was followed by a public meeting and technology forum where 72 presentations were made.

The FDA report addresses the safety and security of the legal U.S. drug supply, which the agency regulates. The FDA does not have the legal authority or resources to assure the safety and efficacy of drugs purchased from other countries outside this legal drug distribution system, or from unregulated Internet sites that are not run by pharmacies licensed and regulated by states.

The report describes specific steps that can be taken now and in the future to protect consumers from counterfeit drugs and to secure the U.S. drug distribution system. These measures include:

• Implementation of new technologies to better protect legitimate drugs against tampering or replacement with counterfeits.
• Adoption of reliable modern track and trace technology, which the FDA has concluded is feasible by 2007, to accomplish and surpass the goals of the Prescription Drug Marketing Act.
• Adoption and enforcement of stronger anti-counterfeiting measures by the state regulators of drug wholesalers and distributors.
• Increased criminal penalties to deter counterfeiting and more adequately punish those convicted.
• Adoption of secure business practices by all participants in the drug supply chain.
• Development of a system that helps ensure timely and effective reporting of counterfeit drugs to the FDA, and that strengthens the ability of the FDA, other regulatory agencies, and the other participants in the drug distribution system to respond rapidly to such reports.
• Education of consumers and health professionals about the risks of counterfeit drugs and about how to respond if they encounter such products.
• Collaboration with foreign stakeholders to develop strategies to deter and detect counterfeit drugs globally.

Implementing these steps will:

• Help prevent the introduction of counterfeit drugs into the U.S. drug distribution chain;
• Facilitate the identification of counterfeit drugs;
• Minimize the risk and exposure of consumers to counterfeit drugs; and
• Avoid unnecessary additional costs in the prescription drug distribution system, and unnecessary restrictions on lower-cost sources of drugs.

The FDA Counterfeit Drug Task Force Final Report is available at www.fda.gov/oc/initiatives/counterfeit/.

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