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About the Issue

Drug counterfeiting is a growing public health problem in the United States. Estimates for counterfeit drugs in North America run in the 1-2 percent range. However, the Food and Drug Administration (FDA) reports the number of fraudulent prescription drugs intercepted by customs officials nearly doubled between 2004 and 2005. Worldwide counterfeit sales are increasing at nearly twice the pace of legitimate pharmaceutical sales—estimated at 13 percent annually by the Center for Medicine in the Public Interest—and will expand to a $75 billion industry by 2010. Moreover, the ability of law enforcement agencies to detect and prosecute counterfeits is low.

Many counterfeit drugs are manufactured in countries like China and India. The variety of fraudulent drugs ranges from crude mixtures of glue, chalk and sugar to nearly exact chemical replicas of complex pharmaceuticals. Because these drugs are neither properly produced nor regulated, it’s nearly impossible for consumers to know exactly what they’re getting. Many phony drugs are sold via legitimate-looking websites, but it’s possible that drugs purchased at reputable pharmacies could be counterfeit.

The FDA encourages consumers to only purchase drugs from state-licensed pharmacies located in the United States, and to check their prescriptions for any changes in appearance or effectiveness. Changes in packaging, labeling, color, taste, pill shape, and unanticipated side effects are telltale signs of counterfeiting. Consumers should only purchase drugs over the Internet from websites with Verified Internet Pharmacy Practice Sites (VIPPS) seals.

Recently, the FDA has increased its efforts to halt drug counterfeiting and issued a report highlighting critical elements it hopes will help keep the U.S. drug supply safe and secure. Based on the work of the FDA's Counterfeit Drug Task Force, the report is part of an initiative to include manufacturers, wholesalers, retailers, pharmacists, consumer groups, and other stakeholders in the fight against counterfeiters. The report, released by Health and Human Services Secretary Tommy Thompson in February 2004, uses a multi-pronged approach to address weaknesses in the drug distribution system. The report makes several recommendations, including:
  • New technologies, such as radio frequency identification (RFID) product tagging, which may be feasible by 2007 and could be an effective way to track and trace drugs from the point of manufacturing to the point of dispensing. Other important anti-counterfeiting technologies include color-shifting inks, holograms, and chemical markers incorporated into a drug or its label. 
  • Stricter licensing requirements that make it more difficult for illegitimate wholesalers to operate.
  • Tougher criminal penalties for manufacturing and distributing counterfeit drugs. The task force found that penalties for fraudulent drugs are substantially less than for other types of counterfeiting, such as fabricating registered trademarks.
  • Requiring everyone in the drug-supply chain to adopt more secure business practices, and barring companies from conducting business with people of unknown background.
  • Increased education for consumers and health professionals about the risks of counterfeiting. The agency will develop educational materials, partner with organizations, and deliver messages through public service announcements and its Web site (www.fda.gov). 
  • International collaboration. The agency intends to work with the World Health Organization, Interpol, and other international organizations on worldwide strategies to combat counterfeiting.
  • Improved reporting systems. If counterfeit drugs get into the system, there should be procedures in place to recognize the problem and quickly alert the public.