There is no shortage of members of Congress who are hot to oversee the FDA activities – Congressman Henry Waxman, Senator Charles Grassley and Congressman Bart Stupak, to name but a few. I do not begrudge anyone from holding a hearing.
However, the hearings held to date have been focused on some very pointed issues related to specific drugs and the FDA activities related to them. Again, well and good I suppose. It gives people like me something to write about.
But perhaps it is time to be less near-sighted. As mentioned in a posting last week, there is growing concern on the role of foreign pharmaceutical producers and the potential for adulterated products entering the U.S. supply chain. The fact is that the FDA does not have capacity for foreign inspections at a rate that might reduce those concerns. And while not a fact yet, it is projected that Chinese pharmaceutical industry will be the fifth largest by 2010.
As demonstrated with the recent spate of adulterated products from China, it does not appear that the Chinese government is matching the Chinese pharmaceutical industry in growing effective regulation over production.
I for one, would be grateful, especially as I swallow my own prescriptions each day, to know that Congress is at least as equally concerned about this macro-issue as they are over every single action over every single drug that the FDA is managing.
No postings on the FDA risk management workshop earlier in the week?
Sorry – I wasn’t able to attend but would have loved to have been there. Unfortunately, I have had some personal issues this week that prevented regular postings about anything.