FDA Starts Targeting High-Risk Drug Imports

Posted on 8th February 2010 by gjohnson in Uncategorized

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Why did it take a complete catastrophe for the FDA to practice what it preached with respect to the safety of foreign drugs. For years the FDA has cautioned that the number one risk to the safety of our drug supply was counterfeit and contaminated drugs from overseas. Yet it is now – two years after the infamous recall of heparin – that the FDA is implementing modern technological methods to help detect problems. Still, this problem isn’t going to be solved by software. Entirely new policies about under what circumstances we will import drugs from overseas must be made. This is too little, too late.

The initiative involving new procedures for U.S. border inspectors comes in the wake of the contaminated blood thinner, heparin. The heparin came from China and had a deadly contaminant in it that caused what is a still unknown number of U.S. deaths in 2007 and 2008. See http://heparin-law.com Toothpaste, pet food and other goods imported from China have also been found to have been dangerous.

For more on the FDA’s new computer process see http://www.reuters.com/article/idUSTRE6135S720100205

Some 20 million shipments of food, medicine and cosmetics will go through ports in the states this year, up 6 million from 10 years ago.

The new program, called “Predict,” uses a computer database to assign a risk score for a product. That score is based on whether a manufacturer has had previous recalls and whether a product has a history of prior contamination.

Goods that score high are pulled out for additional inspection.

“Predict” has been tested in Los Angeles and is being installed in New York. The FDA says the system will be rolled out nationally and in use by the early summer.

Still, with the FDA having a 30 year backlog on inspecting new facilities and a facility able to go online before inspection, this is a system still ripe for a disastor. It is time to stop delegating the manufacture of goods this dangerous to those we cannot control.