Dan Coats: “This committee substitute has been legislated for a 2 rac{1}{2} year period thoroughly and carefully and responsibly. It…”

“This committee substitute has been legislated for a 2 rac{1}{2} year period thoroughly and carefully and responsibly. It is a piece of work that has received a 14-to-4 vote in committee by Democrats and Republicans. People of different philosophical backgrounds have supported it. It is legislation that has survived two filibusters, and the cloture votes have been overwhelming to move forward. It is legislation that has been changed and modified 34 times to meet the objections of the Senator from Massachusetts and some others about its deficiencies; 34 modifications since that 14-to-4 committee vote. There are 8 days left in this month before PDUFA--the tax on the drug companies that funds up to 600 employees at FDA to review and to expedite the review of drugs--8 days left before that authorization expires. The clock is ticking. FDA will be laying off more than 600 people in just 8 days unless we can move this legislation forward. We don't need more filibusters. We don't need more debate. It is time to move forward. If we do not, drug and device reviews will be delayed substantially, and reform will be stopped. Responsible people have legislated responsibly, and I urge my colleagues to support us on this vote coming up.”