In its 2005 update to its Combating Counterfeit Drugs Annual Report, the FDA says it is pursuing several initiatives to further protect the safety and integrity of the US drug supply.
"We believe the US' prescription drug supply is as safe as any in the world, and the FDA is committed to ensuring that this continues," reports Randall Lutter, FDA Acting Associate Commissioner for Policy & Planning.
In 2004, the 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, officials stress.
This increase is partially due to heightened vigilance and awareness by all parts of the drug distribution system, due to the FDA releasing its original report in 2004. More effective coordination with other state, federal and foreign law enforcement agencies, plus 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 the FDA's OCI are showing criminals that if you counterfeit drugs, the FDA will catch you," claims Margaret Glavin, FDA Associate Commissioner for Regulatory Affairs.
During 2004, there also has been considerable progress toward developing and implementing 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 chain of custody for drug products, officials note.
The 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 presumably make it more difficult for counterfeit drugs to enter the distribution system.
For example, in Jan 2005, a Southern California man pled guilty to importing counterfeit Viagra from China and manufacturing 700,000 counterfeit Viagra tablets at a US lab. An accomplice was convicted of similar charges in Sept 2004. The total value of the counterfeit Viagra in this case is over $5.65 mln.
Also, drug manufacturers are increasing their use of anti-counterfeiting technologies that include holograms, color shifting inks, and covert markings on drug products and packaging. In addition, several states are starting to adopt stricter laws for the movement of drugs through the supply chain. The FDA is also strengthening ties with foreign law enforcement agencies and international organizations.