FDA task force issues counterfeiting report
preliminary report on schedule at the end of last week, and said
that it would be preparing a final document for early in 2004.
A US Food and Drug Administration (FDA) task force on counterfeiting of drugs issued its preliminary report on schedule at the end of last week, and said that it would be preparing a final document for early in 2004.
The preliminary conclusions of the report include that there is no single 'magic bullet' against the growing number of sophisticated counterfeiters; rather, a multi-pronged strategy to secure the drug supply could be much more difficult for counterfeiters to overcome than any single method. It could also be less costly, because a 'one-size-fits-all' approach is unlikely to work for all parts of the complex prescription drug supply system.
Also, although drug counterfeiters today are more sophisticated and better organised than ever before, there are many new technologies and approaches that have the potential to prevent and contain counterfeit drug threats.
However, because many of these promising ideas have not been fully developed, the task force believes that an opportunity for broad public comment is essential to guide its further work.
"We know that the drugs available in the US are among the safest in the world, but we still must remain on our guard against those who would exploit patients by selling counterfeit drugs instead," said Health and Human Secretary Tommy Thompson said.
Interestingly, technology features at the head of the task force's list of possible solutions to the problem, ahead of a tightening of the regulatory oversight process and measures to encourage secure business practices, the development of a rapid alert and response system, public education drives and a push for international collaboration on the issue.
FDA Commissioner Mark McClellan set up the task force in July 2002 after the agency noticed an increase in the number of cases of drug counterfeiting it was investigating.
In its report, the task force said it had spoken with many organisations and individuals who believe anti-counterfeiting technologies should be adopted. "'Authentication' and 'track and trace' are two promising types of anti-counterfeiting technologies that came to light," it said.
Authentication technologies to assure that the drug is the real thing fall into three general groups: overt, covert and forensic. Track and trace technologies to help make sure that a product that finds its way to a consumer is a safe and effective drug include radio-frequency identification and barcodes.
The task force learned that both of these technologies are becoming more sophisticated, reliable, and inexpensive. However, a combination of technologies which change over time to stay ahead of the skills of counterfeiters is likely to be optimal, because none is wholly effective in its own right, has a proven track record or is ready for widespread use.
The task force also envisages drawing up a set of best practice guidelines that would be voluntarily adopted by all manufacturers, wholesalers, repackagers and pharmacies. Meanwhile, the adverse event reporting system used by health care workers to report side effects of drugs may be extended to include suspected counterfeiting.
As part of this effort the task force will hold a public meeting and new technology forum on 15 October, during which it will hear testimony from the public on the problem of fake drugs and will learn more about specific anti-counterfeiting technologies. Comments on the proposals will be accepted until 3 November.
