On the recordMay 9, 2007
I oppose the amendment. I appreciate the thought that went into it, and I know that before we did this bill and put into place some of the processes we have in the toolbox for postapproval--which, nevertheless, existed before for the FDA--this amendment would have been necessary. But in light of the toolbox we provide and the dispute resolution we have, it would add an unnecessary layer of bureaucracy. We have designed the bill to be a nimble and responsive process to deal with emerging drug safety issues. We want drugs on the market faster, we want to know about anything that goes wrong faster, and we think that is built into it. We do have a dispute resolution in the bill with tight guidelines that will result in rapid approvals. We don't need the additional process. The amendment separates what should be together and delays what should be rapid. So I urge my colleagues to oppose the amendment.
Source
govinfo.gov
