FDA Consumer

Protecting consumers from counterfeit drugs

Protecting consumers from counterfeit drugs

Drug counterfeiting has been relatively rare in the United States, but the practice has increased in recent years. The Food and Drug Administration has stepped up its efforts to halt drag counterfeiting and has issued a report highlighting critical elements that will help keep the U.S. drug supply safe and secure.

“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,” former FDA Commissioner Mark B. McClellan, M.D., Ph.D., said. “FDA will not rest until we have strong protections in each link of the drug supply chain….”

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 FDA conducted an average of five counterfeit drug investigations per year through the late 1990s, but that number has risen to more than 20 per year since 2000. In 2003, the FDA investigated counterfeiting of the cholesterol-lowering drug Lipitor (atorvastatin) and Procrit (epoetin alfa), an anemia treatment used in people who have cancer and AIDS.

The report, released by Health and Human Services Secretary Tommy G. Thompson in February 2004, uses a multi-pronged approach to address weaknesses in the drug distribution system. The report’s recommendations include:

* New technologies. The FDA believes radio frequency identification (RFID) tagging of products is feasible by 2007, and could be an effective way to track and trace drugs from the point of manufacturing to the point of dispensing. RFID places electromagnetic chips and tags containing a unique serial number onto cartons and individual drug products. Other important anti-counterfeiting technologies include color-shifting inks, holograms, and chemical markers incorporated into a drug or its label.

* Stricter licensing requirements. The FDA is working with the National Association of Boards of Pharmacy on revising model state rules for licensure of wholesale drug distributors to make it more difficult for illegitimate wholesalers to get into business.

* Tougher penalties. The task force found that penalties for counterfeiting drugs are substantially less than for other types of counterfeiting, such as counterfeiting registered trademarks. For example, counterfeiting a prescription drug label that bears a registered trademark is punishable by up to 10 years in prison, while counterfeiting the drug itself is punishable by a maximum of three years in prison. The FDA has requested that the United States Sentencing Commission increase criminal penalties for manufacturing and distributing counterfeit drugs.

* More secure business practices. Effective protection requires everyone in the drug supply chain to adopt secure business practices and to refuse to do business with people of unknown background. The FDA also recommends that businesses identify individuals and teams to take responsibility for security. Additionally, the FDA intends to increase its inspections of repackagers who follow procedures that place them at increased risk for the introduction of counterfeit drugs.

* Increased education. The FDA plans to increase 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 (

* International collaboration. Counterfeit drugs represent a global challenge. The FDA does not have the legal authority or resources to assure the safety and effectiveness of drugs purchased outside of the United States. The agency intends to work with the World Health Organization (WHO), 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. Last year, the pharmaceutical industry announced a voluntary program in which companies agreed to notify the FDA’s Office of Criminal Investigations of suspected counterfeiting within five working days. The FDA also encourages pharmacists and other health professionals to report suspected counterfeit drugs to MedWatch, the agency’s program for reporting safety information and adverse events. And the FDA has announced the creation of a Counterfeit Alert Network, a group of organizations that will spread the word about counterfeiting incidents and general educational messages from the FDA. Several organizations have joined the network, including the American Pharmacists Association, the American Medical Association, the American Society of Health-System Pharmacists, the National Consumers League, and the Academy of Managed Care Pharmacy.

“Americans must have confidence in their medications even as we face more sophisticated and better organized counterfeit operations,” 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.”

The FDA encourages consumers to purchase drugs only from state-licensed pharmacies in the United States, and to check for changes in the drugs they purchase. Be alert to changes in packaging, labeling, color, taste, shape of pill, or unanticipated side effects. Before buying drugs over the Internet, make sure the Web site has a Verified Internet Pharmacy Practice Sites (VIPPS) seal. Consumers who suspect that a drug is counterfeit should contact the pharmacist who dispensed the drug and the FDA at (800) 332-1088.

To access the FDA’s complete report on counterfeit drugs, visit

COPYRIGHT 2004 U.S. Government Printing Office

COPYRIGHT 2004 Gale Group