Jim Jeffords

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I would like to announce for information of the Senate and the public that a Executive Session of the Senate Committee on Labor and Human Resources will be held on Wednesday, September 24, 1997, 9:30 a.m., in SD-430 of the Senate Dirksen Building. The following are on the agenda to be considered: S.1186, Workforce Investment Partnership Act of 1997; and nominations, Public Health Service Corps, 128 candidates. For further information, please call the committee, 202/224-5375. committee on labor and human resources

Mr. JEFFORDS

Mr. JEFFORDS. As I said previously enforcement authority is not covered by the national uniformity provisions. Thus, drug manufacturer licensing and inspection in the States would not be affected.

Mr. JEFFORDS. Enforcement authority is not covered by the preemption provision of the bill, so a State's embargo and other enforcement authority would not be affected.

Mr. JEFFORDS. The public information and communication provisions of S. 830 would not prevent a State from issuing its own public statements to warn the public. But although the State is free to utilize the media and other such avenues, the State could not require point-of-purchase placards to be posted.

Mr. JEFFORDS. In most cases, it will be abundantly clear and States will not have to continually request written interpretations of Federal law. There should be no need to delay enforcement.

Mr. JEFFORDS. 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. Late in the course of negotiations on this bill, FDA raised the possibility that section 404(b) might be interpreted to limit the agency's future tobacco regulation authority. At the time we told the agency we did not agree with their interpretation but eventually offered to insert the rule of construction now before us in the substitute to make absolutely clear our neutrality on the tobacco issue. Subsequently, FDA and others have raised the possibility that section 404(a) of S. 830 could also affect FDA's authority in this area. As you mentioned, the Congressional Research Service, American Law Division, has evaluated S. 830 and determined that it, in fact, does not interfere with any tobacco authority FDA may have. This analysis was made part of the Congressional Record on September 5. None of the provisions of S. 830 or the substitute should be interpreted as taking a position, one way or the other, on whether FDA has any authority under current law to regulate tobacco products, which as you know, is the subject of ongoing litigation in the Federal courts. The intention of the rule of construction in the substitute is to make clear that the Federal courts can continue to determine FDA's authority over tobacco without any interference from this act. Thus, the language in section 404 has no effect on whether or not FDA has authority over tobacco products, it only relates to a procedural aspect of reviewing 510(k) medical device submissions. To sum up, I am pleased to offer an amendment extending the rule of construction to all of section 404 on the basis outlined in my preceding remarks--to keep the bill strictly neutral on the question of FDA tobacco authority, that is that we are not prejudging the outcome of any pending litigation on any tobacco authority the FDA may have. Further, it is my view that if this provision is included in the final FDA reform bill as reported by the conference committee, the conference report should include language which reinforces this point.

Mr. JEFFORDS. Mr. President, I ask for the yeas and nays on adoption of the committee amendment, as modified.

Mr. JEFFORDS. Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. JEFFORDS. I yield to the Senator from Connecticut 2 minutes.

Mr. JEFFORDS. The national uniformity provisions would not affect traditional drug advertising laws because this bill does not address the authority of the Federal Trade Commission Act. State laws that prohibit false and misleading advertising or to prohibit unsubstantiated claims for nonprescription drugs, for example, would not be affected. Traditional advertising issues relating to claims substantiation, fair balanced and truth are outside the scope of national uniformity.

Mr. JEFFORDS. Mr. President, I ask unanimous consent to call up and adopt Senator Hatch's amendment No. 1183, and 1182, as modified by the amendment, which I send to the desk.

Mr. JEFFORDS. Mr. President, I have a unanimous-consent request which I will offer. I ask unanimous consent that immediately following the cloture vote with respect to S. 830, if invoked, there be only the following time remaining in the following fashion: 4 hours equally divided between the chairman and the ranking minority member or their designee for use during today's session only; 4 hours equally divided between the chairman and the ranking minority member or their designee for use during the session of the Senate on Wednesday, September 24, beginning at noon. I further ask, notwithstanding rule XXII, that following the conclusion or yielding back of time, the Senate proceed to vote on S. 830, as amended, without further action or debate.

Mr. JEFFORDS. Mr. President, I yield 2 minutes to the Senator from Indiana.

Mr. JEFFORDS. Mr. President, I yield to the Senator from Tennessee 10 minutes.

Mr. JEFFORDS

Mr. JEFFORDS. Madam President, we are not prepared to at this time, so I suggest the absence of a quorum.

Mr. JEFFORDS. Madam President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. JEFFORDS

Mr. JEFFORDS. I yield 5 minutes to the Senator from New York.

Mr. JEFFORDS. I yield to the Senator from Utah 5 minutes.

Mr. JEFFORDS. What is the pending business?

Mr. JEFFORDS

Mr. JEFFORDS. I yield 2 minutes to the Senator from Iowa.

Mr. JEFFORDS. Mr. President, I ask that the Senate now stand in recess under the order. Thereupon, the Senate, at 12:53 p.m., recessed; whereupon, the Senate, at 2:15 p.m., reassembled when called to order by the Presiding Officer (Mr. Coats). Mr. JEFFORDS addressed the Chair.

Mr. JEFFORDS

Mr. JEFFORDS. We have a very limited debate time.

Mr. JEFFORDS

Mr. JEFFORDS. I yield 2 minutes to the Senator from Iowa.

Mr. JEFFORDS

Mr. JEFFORDS. After the vote.

Mr. JEFFORDS. Mr. President, I ask unanimous consent that the Senate stand in recess until 2:15 p.m., and when the Senate reconvenes, there be only the following time remaining, limited in the following fashion: 20 minutes under the control of Senator Kennedy, 20 minutes under the control of Senator Jeffords, 10 minutes under the control of Senator Harkin, and 10 minutes under the control of Senator Frist.