Foreign FDA offices a good idea. But who pays?
It's easy to get frustrated with the FDA because it is usually slow acting and risk-adverse. So now comes news the Agency is setting up offices and labs in China, India, and other locations to monitor products headed our way. One has to wonder: What, a proactive FDA? After recovering from the shock, you realize this action is exactly the right thing to do.
Of course, concern for the quality of foreign-produced food, medicines, and products spurred the new office plans and stemmed from recalls of tainted pet food, toothpaste, and other imports. In March 2007, for instance, a rash of pet deaths was traced to Chinese pet food laced with melamine, a compound that lets food register a high protein content in tests. Later that year, Mattel and others recalled toys covered with lead paint. Then a few dozen unfortunate residents of Panama died from Chinese-sourced cough medicine. Diethylene glycol was the culprit. It was substituted for more expensive glycerol. Sadly, there are other examples. All in all, many a consumer now checks product labels and remarks with relief, ”Oh good. It's not made in China.”
For some time now, it has seemed time for food-and-drug administrations worldwide to settle on common standards and divide up the increasing workload. But waiting for the world to recognize the obvious is like waiting for glaciers to return. For instance, most countries agree in principle with the RoHS (Reduction of hazardous substances) standards. But there are at least five versions. Cynics suspect that four are redundant.
So far ISO has not led the charge toward unified food-and-drug standards. Fine, let it follow the FDA. Its Deputy Commissioner Murray Lumpkin says the agency will soon have three offices in China, offices in New Delhi and Mumbai by early 2009, and others later on. India warrants attention, says Lumpkin, because it exports a large volume of products to the U.S. And it is increasingly favored for drug company clinical trials.
Since the U.S., China, and India are maturing trading partners, it's time our countries started acting like, well, partners. We are all engaged in economic activities intended for mutual benefit. So there should be no “short end” of the stick.
Chinese officials say they'll accept the controls and adjustments the FDA imposes. That will go a long way toward repairing the country's reputation. Perhaps the benefits won't stop there. Let's hope the Chinese make their domestic products to FDA quality standards. The FDA stamp could also be a selling point in other countries such as India. You could argue that everyone benefits when countries follow FDA quality standards.
Here's the only bone to pick: Who pays for the salaries and equipment in the new FDA foreign offices? The cost could reach tens of millions. For the privilege of selling products in the U.S., would it not make sense for the exporting country to foot the bill? This action would signify acceptance of responsibility for past errors and say clearly by action, “We don't what them to happen again.”
The FDA's MDUFMA fees provide one payment model. The Medical Device User Fee and Modernization Act includes a list of charges device companies must pay the agency for its work verifying claims made by device manufacturers for medical products and before releasing the devices for sale.
Recently, however, the FDA has asked Congress for additional funding to open the new facilities. So in effect, your tax dollars will fund their trade boom. What more would you expect?
Acceptable Use Policy blog comments powered by Disqus
Want to use this article? Click here for options!
© 2009 Penton Media Inc.
advertisement
Webcasts
- Antimicrobial Developments in
Silicone Rubber for the Medical Industry
Sponsored by: Wacker Silicones - View Webcast Archive
advertisement













