On the recordMay 23, 2012
My answer to the chairman through the Chair is that the FDA does nothing quickly now, and he knows that because he has been sitting in oversight over them for years. That is No. 1. The answer to No. 2 is, if the Senator reads the GAO report, they have no explanation on why they do it on some employees and not others. The fact is, if this is a bad thing, why are they doing it on 40 percent of the employees now? The No. 1 and No. 2 things the FDA is charged with are safety and efficacy. Safety comes first. They get graded on how well they do on that. So we have this counterbalance. Well, what we have is a lack of responsiveness even though billions of dollars are going to the FDA from the device companies and the drug companies. Part of the deal was to make them more timely. That means in no way do you ignore safety and in no way do you ignore efficacy. The fact is they do deserve answers, and what is happening a lot of times is they are not. I fully support the bureaucracy of the FDA in terms of them doing their job. I think they do an awfully good job. They are just awfully slow at it, and when you ask why, there is not a good answer. The point is, if there are a large number of employees who are already reviewed as a small component, it doesn't have to be a major one, but it ought to be something you think about. Do I push this off my desk because I am bored with it? Does the timeframe mean anything?…





