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May 18, 2005

Media Inquiries: Rae Jones, 301-827-6242
Consumer Inquiries: 888-INFO-FDA


FDA Continues Combating Counterfeit Drugs
Annual Update Reports on Progress

 Rockville, MD -- Working in collaboration with the private sector and with other government agencies over the past year, the Food and Drug Administration (FDA) is announcing significant progress in the battle against counterfeit prescription drugs. In its annual update to the "Combating Counterfeit Drugs" Report, the FDA reports it is pursuing several initiatives to further protect the safety and integrity of the U.S. drug supply.

"We believe the United States' prescription drug supply is as safe as any in the world, and the FDA is committed to ensuring that this continues," said Randall Lutter, Acting Associate Commissioner for Policy and Planning.

In 2004, FDA's office of Criminal Investigations (OCI) initiated 58 counterfeit drug investigations involving hundreds of thousands of fake dosage units. These cases represent a dramatic increase from the previous year when 30 such cases were initiated. This increase is partially due to heightened vigilance and awareness by all parties in the drug distribution system as a result of the FDA's issuance of its original report in 2004. More effective coordination with other state, federal, and foreign law enforcement agencies and improved communication with drug manufacturers also contributed in large part to the increase in investigations.

"This year's Report illustrates how our Special Agents within FDA's Office of Criminal Investigations (OCI) are showing criminals that if you counterfeit drugs, the FDA will catch you," said Margaret O'K. Glavin, FDA's Associate Commissioner for Regulatory Affairs.

In the last year, there also has been tremendous progress toward the development and implementation of a standard electronic track and trace system using radio-frequency identification (RFID) for widespread use in the drug distribution system. Significant advancements are also being made in developing an electronic pedigree (chain of custody) for drug products. FDA is optimistic that this progress will continue at a rapid pace and will achieve widespread use in the drug supply chain. These changes will make it more difficult for counterfeit drugs to enter the distribution system.

Additionally, drug manufacturers are increasing their use of anti-counterfeiting technologies such as holograms, color shifting inks, and covert markings on drug products and packaging. Also, several states are beginning to adopt stricter laws regarding the movement of drugs through the supply chain. FDA is strengthening ties with foreign law enforcement agencies and international organizations, as well. And, a new FDA consumer education program is informing the public about the risks of counterfeit drugs. In addition, the National Consumers League (NCL) developed a highly informative website containing useful consumer information about counterfeit drugs (http://fraud.org/fakedrugs/). These initiatives are all contributing to a safer drug supply.

The complete FDA "Combating Counterfeit Drugs Annual Update," and the original "Combating Counterfeit Drugs Report," are available at:

"Combating Counterfeit Drugs Annual Update," May 2005: http://www.fda.gov/oc/initiatives/counterfeit/update2005.html

"Combating Counterfeit Drugs Report," February 2004: http://www.fda.gov/oc/initiatives/counterfeit/report02_04.html


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