Magazine article FDA Consumer

Update on Counterfeit Drugs

Magazine article FDA Consumer

Update on Counterfeit Drugs

Article excerpt

The FDA is making significant progress in its fight against counterfeit drugs. In its annual update to a report called "Combating Counterfeit Drugs," the FDA says its Office of Criminal Investigations initiated 58 counterfeit drug investigations involving hundreds of thousands of fake dosage units during 2004. These cases represent a dramatic increase from the previous year when 30 such cases were initiated.

The increase is partially due to heightened vigilance and awareness by all parties in the drug distribution system as a result of the FDA's original report, issued in February 2004. More effective coordination with other state, federal, and foreign law enforcement agencies, and improved communication with drug manufacturers, also contributed to the increase in investigations.

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

In the last year, there has also been tremendous progress with the development and implementation of a standard electronic track and trace system using radio-frequency identification for widespread use in the drug distribution system. Significant advances are also being made in developing an electronic pedigree for drug products. The FDA is optimistic that this progress will continue at a rapid pace and will achieve widespread use in the drug supply chain. …

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