FDA turns up heat on drug counterfeiters
Better education for pharmacists part of plan
The U.S. Food and Drug Administration (FDA) has announced a new initiative to fight drug counterfeiters. As part of the initiative, an internal task force will look into technology and other measures — including better education of pharmacists — to try to stop counterfeit drugs from being distributed with or deliberately substituted for safe and effective drugs.
Although drug counterfeiting is relatively rare in the United States, the amount of such activities has recently increased. The FDA also has reported that counterfeiters now possess a more sophisticated ability to introduce finished dosage counterfeits into the otherwise legitimate drug distribution channels. The FDA’s counterfeit drug investigations have increased to more than 20 per year since 2000, after averaging only about five per year through the late 1990s.
The FDA attributes this increase to a number of factors, including:
• better counterfeiting technology, including improved technology to make labeling, packaging, and products that appear real but are not;
• more organized, more effective criminal groups attracted by financial opportunities; the online sale of prescription drugs by unlicensed pharmacies and/or foreign web sites;
• opportunities for introducing foreign-made counterfeit and unapproved drugs into large and rapidly growing import flows;
• weak spots in the domestic wholesale drug distribution chain, including some wholesalers who acquire most of their inventory from secondary sources, do not maintain effective due diligence efforts on these sources, and ignore warning signs indicative of illegal or unethical behavior.
On the other hand, the scale of worldwide counterfeiting of drugs is much larger. The World Health Organization has estimated that perhaps 7% or 8% of drugs worldwide are counterfeit, and reports from some countries suggest that as much as one-half of their drugs are counterfeit.
The FDA initiative is designed to better identify the risks and threats from counterfeit drugs, to coordinate public and private efforts to fight drug counterfeiting and distribution, and to develop new tools to aid in identifying, deterring, and combating counterfeiting.
The internal FDA task force will be asked to:
• Develop a strategic action plan to decrease the risk of counterfeit drugs entering the U.S. marketplace.
• Continue to strengthen the FDA’s collaborative relationships with other federal agencies, including the Bureau of Immigration and Customs Enforce-ment, the Bureau of Customs and Border Protec-tion, the U.S. Secret Service in the Department of Homeland Security, and entities within the Depart-ment of Justice, as well as with health professionals, industry, consumer, and other stakeholders. These relationships will help the FDA gather information regarding the best practices for dealing with drug counterfeiting.
• Identify ways to strengthen the nation’s protections against counterfeiting. These could include model practice acts for adoption by the states, best practices for those who sell and distribute prescription drugs, and better education for patients, pharmacists, and others about how to identify counterfeit drugs and alert others to their existence.
• Assess the extent to which new technologies, such as counterfeit-resistant packaging, product identifiers, and implanted radio frequency chips in packaging, can help assure the authenticity of drugs.
The task force is scheduled to submit its initial findings and recommendations in September and will issue a final report in four months, after the task force has the opportunity to hear from the public. In addition, the FDA plans to coordinate more closely with other federal agencies and state and local governments that share the responsibilities with the FDA for ensuring the safety of the U.S. drug supply and distribution system, as well as with members of Congress who have worked closely with the FDA in the past on these important public health issues.
After the FDA made its announcement in July, pharmacy groups such as the American Society of Health-System Pharmacists in Bethesda, MD, issued statements saying they supported the initiative and looked forward to providing the agency with helpful information.
The U.S. Food and Drug Administration (FDA) has announced a new initiative to fight drug counterfeiters. As part of the initiative, an internal task force will look into technology and other measures including better education of pharmacists to try to stop counterfeit drugs from being distributed with or deliberately substituted for safe and effective drugs.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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