James M. Jeffords: “Yes. This amendment I believe will address the concerns of several Senators who have a concern regarding the effect of…”

“Yes. This amendment I believe will address the concerns of several Senators who have a concern regarding the effect of this legislation on FDA's authority to regulate tobacco. I believe we all have the same intent. In drafting S. 830, my intent was and is to improve the efficiency and accountability of the product review process at FDA. In drafting section 404, we modified a provision in the FDA reform bill from the 104th Congress in an effort to more accurately capture our policy intent--my point is that the subject matter is section 404 has been under consideration in the Senate Labor Committee, as well as in legislation introduced in the House, for several years. The concern over FDA's tobacco authority came to our attention only after the markup of this bill in committee, in June of this year. Section 404 introduces needed elements of due process to certain, very limited aspects of medical device reviews. None of the language in S. 830 is intended to address FDA's tobacco authority.”