On Sunday, two of the nation’s leading papers, the New York Times and the Washington Post both carried front page articles relating to the safety of medical products or components of medical products from China.
The Times article, "FDA Tracked Tainted Drugs, but Trail Went Cold in China" was about the flow of materials from China that resulted in deaths in Haiti as a result of tainted cough syrup. Recently there has been a spate of issues involving Chinese exports in toothpaste, cough syrup (above mentioned) not to mention the pet food issue.
The Post article "Drugs from Overseas Flood U.S." This article documents the increasing flow of drug products from foreign nations and the FDA’s inability to monitor safety.
"FDA officials say they have recently begun a risk-based approach to manufacturing oversight — one that seeks to ensure that drugmakers have proper quality-control systems and that requires fewer inspections. But they acknowledge that financial constraints keep them from making more of the expensive and often hard-to-organize visits to plants in India and China."
Clearly, PDUFA funds are not designed to address this burgeoning issue. It is difficult to imagine that U.S. industries pay PDUFA fees to inspect plants that may, in many instances, be those of competitors.
There are a few things to take note of here.
One is that the foreign countries producing these compounds have to do a good job of communicating what they are doing to ensure safety. For China, that is going to be quite a job given the high profile problems associated with their products.
Two is that there needs to be a funding mechanism, perhaps a user fee for foreign imports, that supplies the FDA with a funding stream that is going to allow the FDA to inspect foreign facilities more closely.
Neither of these suggestions will address the range of issues addressed in these two articles. But this combined newspaper reporting makes clear that there is a problem, whether it is perception or real. And certainly the news that has made headlines lately has not been on the perception side.