In its annual update to the Combating Counterfeit Drugs report, released last week, the agency reported on developments in several initiatives aimed at protecting the safety and integrity of the U.S. drug supply.
In 2004, the FDA Office of Criminal Investigations initiated 58 counterfeit drug investigations involving hundreds of thousands of fake dosage units. This is a dramatic rise from the 30 cases in 2003 and is partially due to heightened vigilance and awareness by all parties in the drug distribution system following the FDA's original report in 2004, says the agency.
In addition, it maintains that more effective coordination with other state, federal and foreign law enforcement agencies and improved communication with drugmakers also contributed in large part to the increase.
There also has been great progress towards development and implementation of a standard electronic track-and-trace system using radio-frequency identification (RFID) for widespread use in the drug distribution system, according to the FDA. And significant advances are also being made in developing an electronic pedigree (chain of custody) for drugs, it said.
The pharmaceutical industry is contributing to this effort by increasing its use of anti-counterfeiting technologies such as holograms, colour shifting inks and covert markings on products and packaging, in addition to starting pilot studies on RFID.
Manwhile, several states are starting to adopt stricter laws regarding the movement of drugs through the supply chain, notably Florida which has implemented an extensive drug pedigree system, despite some resistance by drugstores.
"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," said Randall Lutter, the agency's acting associate commissioner for policy and planning.
A new FDA consumer education program is also informing the public about the risks of counterfeit drugs, and the National Consumers League (NCL) has developed a website containing useful consumer information about counterfeit drugs. These initiatives are all contributing to a safer drug supply, according to the FDA.