Sunday, January 20, 2008
I want to agree with Kelly Hills that the FDA as currently structured and funded is not capable of reviewing the information disclosed by insurance companies. It must be a two part plan. First, all the data must be disclosed so that anyone, including independent oversight groups, can look at the data. But second, the FDA needs to be given resources to do the kind of review of this data that safety requires before releasing a drug on the market. Others know more about this than I do, but I have not seen any particular evidence that the FDA has become so politicized that they would not do this review if they had the resources. If, however, that were the case then it would be necessary to fund independent oversight.