Political Quotes

“this is an amendment that comes out of a study of GAO's findings, and GAO did a wonderful job looking at the FDA. What we found out--part of it will be covered if, in fact, we do this other study on the management, but what GAO is telling us is that there is an irregular pattern of performance review at the FDA. Part of the evaluation of about 40 percent of the people who are involved in the drug and device approval process, in terms of their performance review, has to do with the timeliness of their work product. And it is only a small component, but it is still a component of it. What this amendment does is it says: FDA, make this part of your component on the people who are actually reviewed in the review process--not to try to push them to do it better but to have a management tool with which to evaluate individual employees doing this. The fact that they are already doing this on some--and what GAO really said is that it is just a lack of management effectiveness that they have not installed it everywhere else. All this amendment says is that this should be one component as they evaluate their employees on their performance reviews and ask: How did you do on timeliness? Was your work product timely? The idea behind this is not to push drugs out that should not be approved. It is not to push out devices that should not be approved.…”