The calls for a national track and trace system, which had died down when legislation was nixed last year, have been revived after more counterfeit cancer drugs have been discovered in the U.S.
An FDA-financed report not only calls for a national electronic tracking system, but it also says the U.S. needs to get a tighter regulatory grip on secondary wholesalers. It characterizes them as the weakest link in the U.S. drug distribution chain. The report from the Institute of Medicine (IOM) cites the recent discovery of counterfeit versions of Roche's ($RHHBY) Altuzan, the trade name in Turkey for the cancer drug branded Avastin in the U.S., as proof that the U.S. needs better protections. Momentum for a track and trace system built last year after the FDA discovered that doctor practices throughout the U.S. had been shipped counterfeit Avastin.
The report focuses much of its attention on developing countries, saying that the substandard and counterfeit drugs are killing people around the world. It says they also inflate the costs of countries that support vaccination or treatment programs by leading to higher drug resistance. It says there needs to be global standards for drug manufacturing and that the U.S., Europe and other developed areas have got to help enforce them.
"Given the international nature of modern manufacturing and trade, every nation has a stake and a role to play in ensuring the production and sale of high-quality medications," said Lawrence O. Gostin, a professor at Georgetown University Law Center and a director of the World Health Organization's (WHO) public health law group.
In a statement posted to the FDA website, FDA Commissioner Margaret Hamburg responded to the report saying her agency is trying to intercept substandard and counterfeit products by "transforming from a predominantly domestically focused agency to one that is fully prepared to help ensure product safety and quality within a globalized world." She noted that the FDA already has personnel in 12 countries to cover 7 regions.
Proponents of having the drug industry institute some form of track and trace had inserted plans for a program in the proposed FDA user fee legislation last year. But with lawmakers unable to agree on details between what the FDA was seeking and what the industry was willing to sign off on, the plan got scrapped during reconciliation negotiations. The industry has raised opposition, citing the cost of technology that would be needed to secure every one of the multiple distribution points.
The report also suggests that state boards work with the FDA to create a public database for states "to report violations and license suspensions and cancelations of wholesalers." It says that, "Although some states already set high accreditation standards, wholesalers engaged in questionable practices can easily work in states with lower standards."
- here's the release
- see Dr. Hamburg's remarks