Are Increased Foreign Inspections of Plants the Answer to Better Risk Management?

J0426621 This week, Senators Kennedy and Grassley announced that they were reviving a legislative proposal from the last Congress that would increase the ability of the FDA to conduct foreign inspections of manufacturing facilities for drugs and devices where components are made outside the U.S. – which is a lot of drugs and devices.  

Called the Drug and Devices Accountability Act – the proposal would collect fees which could be applied to increased foreign inspections.   Senator Grassley said in his statement about the proposed legislation that it is a "practical solution to beefing up the FDA's inspection work…"  But is it really?

The complexity of that work becomes clear in a statement by then FDA Commissioner Andrew C. von Eschenbach before Congress on November 1, 2007 where he outlined how extensively the supply chain for finished products in the U.S. was reliant at some point on foreign production.He cited the real problem was one of information technology in providing support in the form of data bases that help FDA decide when and where to inspect.   And, in May 2008, the GAO said in a report that while the FDA had improved their data bases, it was too early to tell if the changes would have a positive effect.  Further, the report said, the FDA conducts relatively few inspections of foreign establishments.  Further, the GAO said that the data bases of the FDA need to be reconciled manually, and that there are several logistical problems to the foreign inspections by the FDA and that reliance on the current system has resulted in a startlingly small number of inspections.  That echoes findings by earlier GAO reports.  

On top of the GAO report, there are also media reports that the current field offices are also having problems in terms of their relationships in foreign countries and whether or not their presence signifies a "witch hunt."

But the Grassley statement on the bill only refers to increased inspections and fees to be collected.  There was nothing about the improvement of data management or the complete reconfiguration of the approach to foreign inspections.  It does not seem like FDA needs more of the same, as much as something new and comprehensive.

Remember the tale of the little Dutch boy?  He is walking by a dyke, notices a hole in the dyke where water is leaking.  He plugs it with a finger and a passer by goes and gets help.  It is a fable designed to teach us that quick action means that disaster can be averted.

But our little Dutch boy is facing a dyke with more than one hole.  There are more holes than he has fingers.  And the passer by is going to stay and do the same thing – even though the two of them have an inadequate number of fingers to address all the leaks.  That is sort of what the Kennedy-Grassley proposal is like.  Increasing the number of inspections of foreign facilities using a lot of money to do so, but probably not increasing the safety factor by any measurable amount because there are simply too many holes left to plug.   That suggests a more comprehensive approach is needed and, in this environment, quick action is needed.  
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2 Responses to Are Increased Foreign Inspections of Plants the Answer to Better Risk Management?

  1. Derek says:

    So what’s your proposal for the “more comprehensive approach”? I agree that sticking fingers in holes in dikes may not be the way to go; but if you pick the holes to stop up, and they’re the big ones and not just the easiest to get to, at least something is being done to reduce risk.

  2. Doug says:

    This approach presupposes foreign manufacture as a given. An alternative is to return manufacture of APIs to previously approved and monitored facilities in the US and EU. Applied innovation to modify processes, which would include facilitated approval of those modified processes, is possible even for generics using bioprocessing as a replacement for chemical synthesis.

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