Congress should give the Food & Drug Administration authority and resources to establish a mandatory track-and-trace system that provides information about where a particular drug is at any time and where it has been, a new report from the Institute of Medicine (IOM) concludes.
The report comes amid increasing concerns about substandard and fake drugs, including the discovery by FDA of counterfeit batches of the cancer drug Avastin.
Securing the supply chain is critical to ensuring the quality of medicine and reducing the global problem of counterfeit drugs, says Lawrence O. Gostin, chair of the IOM committee that studied the growing threat. “The consequences of these illegitimate drugs are compromised treatment,” he says. “They may have no therapeutic active ingredient or [may have] a lower amount, they can harm patients, and in some cases they can kill.”
The committee emphasizes that poor-quality medicine is a worldwide problem. It calls on the World Health Organization to develop a global code of practice for drug surveillance, regulation, and law enforcement.
In the U.S., the committee found that secondary wholesalers are the weakest link in the drug distribution chain. State licensing and regulation of wholesalers vary widely, and there is no national database on drug wholesalers. The committee urges FDA to work with states to develop such a database to prevent wholesalers from simply going to another state after they lose their license or fail to meet a particular state’s requirements.
FDA Commissioner Margaret A. Hamburg welcomed the committee’s recommendations. Although previous FDA efforts to track drugs have been unsuccessful, Hamburg is optimistic she can transform FDA from a domestically focused agency into one that ensures product safety and quality in a globalized world.