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 drug counterfeiting and has issued a report
highlighting critical elements that will help keep the U.S. drug supply safe
"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
- 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
- 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 (www.fda.gov).
- 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
that are located in the United States, and to check for changes in the drugs
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 www.fda.gov/oc/initiatives/counterfeit/.