[Congressional Record Volume 142, Number 92 (Thursday, June 20, 1996)]
[Senate]
[Pages S6586-S6605]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




        NATIONAL DEFENSE AUTHORIZATION ACT FOR FISCAL YEAR 1997

  The Senate continued with the consideration of the bill.


                           Amendment No. 4049

  Mr. EXON. Mr. President, on the matter at hand with regard to the 
amendment offered by the Senator from Arizona on the Comprehensive Test 
Ban Treaty, I indicated in my remarks of yesterday that the 
administration, and others, who have a firsthand say, had a firsthand 
look at the Comprehensive Test Ban Treaty are all opposed to the Kyl 
amendment. I would like to read briefly at this time the letters that I 
have received from some of the agencies.
  First, a letter I received from the United States Arms Control and 
Disarmament Agency, from Mr. John D. Holum.

       Dear Senator Exon: Special Assistant to the President for 
     Legislative Affairs, William C. Danvers, has provided you the 
     Administration's reason for opposing the Kyl-Reid amendment 
     to the FY 1997 Defense Authorization Bill.
       As I represent the lead agency in the Comprehensive Test 
     Ban Treaty negotiations in Geneva, I want to emphasize our 
     belief that this amendment could undermine our efforts 
     to negotiate a Treaty that would end nuclear testing for 
     all time by suggesting a possible U.S. interest in 
     resuming testing before the CTBT enters into force, that 
     does not, in fact, exist.

       Since the end of President Eisenhower's tenure, the United 
     States has pursued a CTBT as the long-term goal. Now, when 
     such a treaty is in hand, we urge the members of the Senate 
     to oppose this amendment and to reaffirm our country's 
     longstanding bipartisan efforts to achieve a CTBT.

  A second memorandum from the Secretary of Energy:

       The nuclear weapons testing moratorium instituted by the 
     Hatfield-Exon-Mitchell amendment has made a significant 
     contribution to the U.S. nuclear non-proliferation 
     efforts. During the duration of the moratorium, the U.S. 
     stockpile of nuclear weapons has remained safe and 
     reliable. There is no requirement to resuming testing or 
     even to plan to resume testing for safety or reliability 
     or any other purpose, at this time. The Department of 
     Energy, with the full support of the Department of 
     Defense, has embarked on an ambitious stockpile 
     stewardship program to ensure that the safety and 
     reliability of the stockpile is maintained into the 
     foreseeable future, without nuclear testing. One of the 
     elements of stockpile stewardship is maintaining the 
     readiness of the Nevada Test Site to resume testing if it 
     is in the supreme national interest of the United States 
     to do so. DOE is committed to maintaining this readiness, 
     consistent with Presidential direction. DOE has confidence 
     in the stockpile stewardship program and does not need the 
     authority that this amendment would provide.
       President Clinton has already outlined his commitment to 
     maintain the safety and reliability of the nuclear stockpile 
     under the existing moratorium and under a comprehensive test 
     ban treaty. It is premature to make any statutory changes to 
     the existing moratorium legislation. Any changes should be 
     made only in the context of a negotiated and signed 
     comprehensive test ban treaty. Any changes in the current 
     statutory prohibition on underground nuclear weapons testing 
     at

[[Page S6587]]

     this time certainly does not help the negotiation process, 
     and could very well set it back. Achieving a comprehensive 
     test ban treaty is a key to reducing the global nuclear 
     danger including proliferation of nuclear weapons and the 
     spread of nuclear terrorism.

  Last, Mr. President, a letter from the National Security Council.
  These are of the same date.

       Dear Senator Exon: You have requested the Administration's 
     views on the amendment offered by Senators Kyl and Reid 
     concerning nuclear testing and the Comprehensive Test Ban 
     Treaty (CTBT). The Administration is strongly opposed to this 
     amendment.
       We believe that the amendment could not come at a worse 
     time. The states that are negotiating in the CTBT 
     negotiations in the Conference on Disarmament (CD) in Geneva 
     have set a deadline of June 28--next Friday--to complete this 
     historic treaty. The amendment could be interpreted by some 
     CD states as signaling a possible U.S. intent to conduct a 
     round of nuclear testing after the CTBT is completed but 
     before it enters into force. The Administration has no such 
     plans or intentions, nor has it requested funding for any 
     such tests. Moreover, the amendment would relax the existing 
     legislative moratorium on U.S. testing just at the time the 
     only remaining state still conducting nuclear tests, China, 
     has announced that it will joint the global moratorium in 
     September.
       As you know, we are confident that our Science-Based 
     Stockpile Stewardship will ensure that we can meet the 
     challenge of maintaining the reliability and safety of our 
     nuclear inventory absent nuclear testing. Nonetheless, 
     because he considers this to be a supreme national interest 
     of the United States, the President has pledged that after 
     the CTBT enters into force, he would be prepared to withdraw 
     from the Treaty in the event, however unlikely, that he was 
     informed by the Secretaries of Defense and Energy that a high 
     level of confidence in the safety or reliability of a nuclear 
     weapon type critical to our nuclear deterrent could no longer 
     be certified. There is concern on the part of the amendment's 
     co-sponsors that if such a problem arose after September 30 
     but before the CTBT entered into force, current law would 
     prohibit remedial testing.
       If that were to occur, it is important to recognize that 
     one or more years would be required to prepare for any 
     resumption of nuclear testing at the Nevada Test Site. During 
     this time, we would be able to obtain the necessary funding 
     and legislative relief to carry out the necessary tests.
       In short, the Administration believes that the Kyl-Reid 
     Amendment is not only not necessary, but it also entails a 
     genuine risk of delaying or derailing the CTBT negotiations 
     just as we may well be poised to achieve a global ban on 
     nuclear testing.

  Signed by the Special Assistant to the President on Legislative 
Affairs.
  Mr. President, I ask unanimous consent that these three letters be 
printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                    United States Arms Control and


                                           Disarmament Agency,

                                    Washington, DC, June 19, 1996.
     Hon. J. James Exon,
     U.S. Senate, Washington, DC.
       Dear Senator Exon: Special Assistant to the President for 
     Legislative Affairs, William C. Danvers, has provided you the 
     Administration's reasons for opposing the Kyl/Reid amendment 
     to the FY 1997 Defense Authorization Bill.
       As I represent the lead agency in the Comprehensive Test 
     Ban Treaty (CTBT) negotiations in Geneva, I want to emphasize 
     our belief that this amendment could undermine our efforts to 
     negotiate a Treaty that would end nuclear testing for all 
     time by suggesting a possible U.S. interest in resuming 
     testing before a CTBT enters into force, that does not, in 
     fact, exist.
       Since the end of President Eisenhower's tenure, the United 
     States has pursued a CTBT as a long-term goal. Now, when such 
     a treaty is in hand, we urge the members of the Senate to 
     oppose this amendment and to reaffirm our country's 
     longstanding bipartisan efforts to achieve a CTBT.
           Sincerely,
     John D. Holum.
                                                                    ____


             Statement of Secretary of Energy Hazel O'Leary

       The nuclear weapons testing moratorium instituted by the 
     Hatfield-Exon-Mitchell amendment has made a significant 
     contribution to U.S. nuclear non-proliferation efforts. 
     During the duration of the moratorium, the US stockpile of 
     nuclear weapons has remained safe and reliable. There is no 
     requirement to resuming testing or even to plan to resume 
     testing for safety or reliability or any other purpose, at 
     this time. The Department of Energy, with the full support of 
     the Department of Defense, has embarked on an ambitious 
     stockpile stewardship program to ensure that the safety and 
     reliability of the stockpile is maintained into the 
     foreseeable future, without nuclear testing. One of the 
     elements of stockpile stewardship is maintaining the 
     readiness of the Nevada Test Site to resume testing if it is 
     in the supreme national interest of the United States to do 
     so. DOE is committed to maintaining this readiness, 
     consistent with Presidential direction. DOE has confidence in 
     the stockpile stewardship program and does not need the 
     authority that this amendment would provide.
       President Clinton has already outlined his commitment to 
     maintain the safety and reliability of the nuclear stockpile 
     under the existing moratorium and under a comprehensive test 
     ban treaty. It is premature to make any statutory changes to 
     the existing moratorium legislation. Any changes should be 
     made only in the context of a negotiated and signed 
     comprehensive test ban treaty. Any changes in the current 
     statutory prohibition on underground nuclear weapons testing 
     at this time certainly does not help the negotiation process, 
     and could very well set it back. Achieving a comprehensive 
     test ban treaty is a key to reducing the global nuclear 
     danger including proliferation of nuclear weapons and the 
     spread of nuclear terrorism.
                                                                    ____



                                    National Security Council,

                                    Washington, DC, June 19, 1996.
     Hon. J. James Exon,
     U.S. Senate, Washington, DC.
       Dear Senator Exon: You have requested the Administration's 
     views on the amendment offered by Senators Kyl and Reid 
     concerning nuclear testing and the Comprehensive Test Ban 
     Treaty (CTBT). The Administration is strongly opposed to this 
     amendment.
       We believe that the amendment could not come at a worse 
     time. The states that are negotiating in the CTBT 
     negotiations in the Conference on Disarmament (CD) in Geneva 
     have set a deadline of June 28--next Friday--to complete this 
     historic treaty. The amendment could be interpreted by some 
     CD states as signaling a possible U.S. intent to conduct a 
     round of nuclear testing after the CTBT is completed but 
     before it enters into force. The Administration has no such 
     plans or intentions, nor has it requested funding for any 
     such tests. Moreover, the amendment would relax the existing 
     legislative moratorium on U.S. testing just at the time the 
     only remaining state still conducting nuclear tests, China, 
     has announced that it will join the global moratorium in 
     September.
       As you know, we are confident that our Science-Based 
     Stockpile Stewardship will ensure that we can meet the 
     challenge of maintaining the reliability and safety of our 
     nuclear inventory absent nuclear testing. Nonetheless, 
     because he considers this to be a supreme national interest 
     of the United States, the President has pledged that after 
     the CTBT enters into force, he would be prepared to withdraw 
     from the Treaty in the event, however unlikely, that he was 
     informed by the Secretaries of Defense and Energy that a high 
     level of confidence in the safety or reliability of a nuclear 
     weapon type critical to our nuclear deterrent could no longer 
     be certified. There is concern on the part of the amendment's 
     co-sponsors that if such a problem arose after September 30 
     but before the CTBT entered into force, current law would 
     prohibit remedial testing.
       If that were to occur, it is important to recognize that 
     one or more years would be required to prepare for any 
     resumption of nuclear testing at the Nevada Test Site. During 
     this time, we would be able to obtain the necessary funding 
     and legislative relief to carry out the necessary tests.
       In short, the Administration believes that the Kyl-Reid 
     Amendment is not only not necessary, but it also entails a 
     genuine risk of delaying or derailing the CTBT negotiations 
     just as we may well be poised to achieve a global ban on 
     nuclear testing.
           Sincerely,

                                           William C. Danvers,

                                Special Assistant to the President
                                          for Legislative Affairs.

  Mr. EXON. I thank my colleague from Arkansas.
  The PRESIDING OFFICER. Under the unanimous consent agreement, the 
Senator from Idaho is now recognized.
  Mr. CRAIG. Mr. President, let me thank the Senator from Arkansas for 
yielding me this valuable time.


                           Amendment No. 4085

(Purpose: To amend the Waste Isolation Pilot Plant Land Withdrawal Act)

  The PRESIDING OFFICER. The clerk will report.
  The bill clerk read as follows:

       The Senator from Idaho [Mr. Craig], for himself, Mr. 
     Kempthorne, Mr. Domenici, Mr. Bingaman, Mr. Murkowski, and 
     Mr. Johnston, proposes an amendment numbered 4085.

  Mr. CRAIG. Mr. President, I ask unanimous consent that further 
reading of the amendment be dispensed with.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment is as follows:

       On page 446, after line 12, insert the following subtitle:

     Subtitle E.--Waste Isolation Pilot Plant Land Withdrawal Act 
                              Amendments.

     SECTION 1. SHORT TITLE AND REFERENCE.

       (a) Short Title.--This Act may be cited as the ``Waste 
     Isolation Pilot Plant Land Withdrawal Amendment Act''.
       (b) Reference.--Except as otherwise expressly provided, 
     whenever in this Act an

[[Page S6588]]

     amendment or repeal is expressed in terms of an amendment to, 
     or repeal of, a section or other provision, the reference 
     shall be considered to be made to a section or other 
     provision of the Waste Isolation Pilot Plant Land Withdrawal 
     Act (Public Law 102-579).

     SEC. 2. DEFINITIONS.

       Paragraphs (18) and (19) of section 2 are repealed.

     SEC. 3. TEST PHASE AND RETRIEVAL PLANS.

       Section 5 and the item relating to such section in the 
     table of contents are repealed.

     SEC. 4. MANAGEMENT PLAN.

       Section 4(b)(5)(B) is amended by striking ``or with the 
     Solid Waste Disposal Act (42 U.S.C. 6901 et seq.)''.

     SEC. 5. TEST PHASE ACTIVITIES.

       Section 6 is amended--
       (1) by repealing subsections (a) and (b),
       (2) by repealing paragraph (1) of subsection (c).
       (3) by redesignating subsection (c) as subsection (a) and 
     in that subsection--
       (A) by repealing subparagraph (A) of paragraph (2),
       (B) by striking the subsection heading and the matter 
     immediately following the subsection heading and inserting 
     ``Study.--The following study shall be conducted:'',
       (C) by striking ``(2) Remote-handled waste.--'',
       (D) by striking ``(B) Study.--'',
       (E) by redesignating clauses (i), (ii), and (iii) as 
     paragraphs (1), (2), and (3), respectively, and
       (F) by realigning the margins of such clauses to be margins 
     of paragraphs,
       (5) in subsection (d), by striking ``, during the test 
     phase, a biennial'' and inserting ``a'' and by striking ``, 
     consisting of a documented analysis of'' and inserting ``as 
     necessary to demonstrate'', and
       (6) by redesignating subsection (d) as subsection (b).

     SEC. 6. DISPOSAL OPERATIONS.

       Section 7(b) is amended to read as follows:
       ``(b) Requirements for Commencement of Disposal 
     Operations.--The Secretary may commence emplacement of 
     transuranic waste underground for disposal at WIPP only upon 
     completion of--
       ``(1) the Administrator's certification under section 
     8(d)(1) that the WIPP facility will comply with the final 
     disposal regulations;
       ``(2) the acquisition by the Secretary (whether by 
     purchase, condemnation, or otherwise) of Federal Oil and Gas 
     Leases No. NMNM 02953 and No. NMNM 02953C, unless the 
     Administrator determines, under section 4(b)(5), that such 
     acquisition is not required; and,
       ``(3) the expiration of the 30-day period beginning on the 
     date on which the Secretary notifies Congress that the 
     requirements of section 9(a)(1) have been met.''.

     SEC. 7. ENVIRONMENTAL PROTECTION AGENCY DISPOSAL REGULATIONS.

       (a) Section 8(d)(1).--Section 8(d)(1) is amended--
       (1) by amended subparagraph (A) to read as follows:
       ``(A) Application for compliance.--Within 30 days after the 
     date of the enactment of the Waste Isolation Pilot Plant Land 
     Withdrawal Amendment Act, the Secretary shall provide to 
     Congress a schedule for the incremental submission of 
     chapters of the application to the Administrator beginning no 
     later than 30 days after such date. The Administrator shall 
     review the submitted chapters and provide requests for 
     additional information from the Secretary as needed for 
     completeness within 45 days of the receipt of each chapter. 
     The Administrator shall notify Congress of such requests. The 
     schedule shall call for the Secretary to submit all chapters 
     to the Administrator no later than October 31, 1996. 
     The Administrator may at any time request additional 
     information from the Secretary as needed to certify, 
     pursuant to subparagraph (B), whether the WIPP facility 
     will comply with the final disposal regulations.''; and
       (2) in subparagraph (D), by striking ``after the 
     application is'' and inserting ``after the full application 
     has been''.
       (b) Section 8(d)(2), (3).--Section 8(d) is amended by 
     striking paragraphs (2) and (3), by striking ``(1) Compliance 
     with disposal regulations.--'', and by redesignating 
     subparagraphs (A), (B), (C), and (D) of paragraph (1) as 
     paragraph (1), (2), (3), and (4), respectively.
       (c) Section 8(g).--Section 8(g) is amended to read as 
     follows:
       ``(G) Engineered and Natural Barriers, Etc.--The Secretary 
     shall use both engineered and natural barriers and any other 
     measures (including waste form modifications) to the extent 
     necessary at WIPP to comply with the final disposal 
     regulations.''.

     SEC. 8. COMPLIANCE WITH ENVIRONMENTAL LAWS AND REGULATIONS.

       (a) Section 9(a)(1).--Section 9(a)(1) is amended by adding 
     after and below subparagraph (H) the following: ``With 
     respect to transuranic mixed waste designated by the 
     Secretary for disposal at WIPP, such waste is exempt from 
     treatment standards promulgated pursuant to section 3004(m) 
     of the Solid Waste Disposal Act (42 U.S.C. Sec. 6924(m)) and 
     shall not be subject to the land disposal prohibitions in 
     section 3004(d), (e), (f), and (g) of the Solid Waste 
     Disposal Act.''.
       (b) Section 9(b).--Subsection (b) of section 9 is repealed.
       (c) Section 9(c)(2).--Subsection (c)(2) of section 9 is 
     repealed.
       (d) Section 14.--Section 14 is amended--
       (1) in subsection (a), by striking ``No provision'' and 
     inserting ``Except for the exemption from the land disposal 
     restrictions described in section 9(a)(1), no provision''; 
     and
       (2) in subsection (b)(2), by striking ``including all terms 
     and conditions of the No-Migration Determination'' and 
     inserting ``except that the transuranic mixed waste 
     designated by the Secretary for disposal at WIPP is exempt 
     from the land disposal restrictions described in section 
     9(a)(1)''.

     SEC. 9. RETRIEVABILITY.

       (a) Section 10.--Section 10 is amended to read as follows:

     ``SEC. 10. TRANSURANIC WASTE.

       ``It is the intent of Congress that the Secretary will 
     complete all actions required under section 7(b) to commence 
     emplacement of transuranic waste underground for disposal at 
     WIPP no later than November 30, 1997.''.
       (b) Conforming Amendment.--the item relating to section 10 
     in the table of contents is amended to read as follows:

``Sec. 10. Transuranic waste.''.

     SEC. 10. DECOMMISSIONING OF WIPP

       Section 13 is amended--
       (1) by repealing subsection (a), and
       (2) in subsection (b), by striking ``(b) Management Plan 
     for the Withdrawal After Decommissioning.--Within 5 years 
     after the date of the enactment of this Act, the'' and 
     inserting ``The''.

     SEC. 11. ECONOMIC ASSISTANCE AND MISCELLANEOUS PAYMENTS.

       (a) Section 15(a) is amended by adding at the end the 
     following: ``An appropriation to the State shall be in 
     addition to any appropriation for WIPP.''.
       (b) $20,000,000 is authorized to be appropriated in fiscal 
     year 1997 to the Secretary for payment to the State of New 
     Mexico for road improvements in connection with the WIPP.

  Mr. CRAIG. Mr. President, this is an amendment that has been offered 
by myself, Senator Kempthorne, Senator Domenici, Senator Bingaman, 
Senator Murkowski, and Senator Johnston. It deals with a very important 
part of our nuclear waste management in this country, specifically the 
waste isolation pilot plant in Carlsbad, NM.
  In working with all of our colleagues, our effort has been to remove 
the unnecessary delays and bureaucratic requirements to achieve the 
major environmental objectives that are so critical to the State of New 
Mexico, and to save taxpayers' money, while at the same time showing 
our country that we can move and act responsibly in the area of 
transuranic waste.
  The amendment that we have before us, that will become a part of this 
pending legislation, will amend the Waste Isolation Pilot Plant Land 
Withdrawal Act of 1992 in several ways. It deletes obsolete language of 
the 1992 act. Particularly important is the reference and requirements 
for ``test phase" activities.
  Since the enactment of the 1992 act, the Department of Energy has 
abandoned the test phase that called for underground testing in favor 
of above ground laboratory test programs.
  This amendment, Mr. President, is agreed to by the Department of 
Energy and by the Environmental Protection Agency. It allows the kind 
of phase necessary to test to completion to assure all of our citizens, 
and especially the citizens of New Mexico, that this is a safe and 
sound facility.
  Most important, along with all of this, in streamlining the process, 
it would remove duplicative regulation and save the taxpayers' dollars. 
We hope that it will have that effect.
  Mr. President, my amendment will clear up several unnecessary and 
delaying bureaucratic requirements that currently exist in the Waste 
Isolation Pilot Land Withdrawal Act, Public Law 102-579, so the WIPP 
facility can be opened. It also meets a major environmental objective 
while saving the taxpayer money.
  The purpose of the WIPP is to provide for the safe disposal of 
transuranic [TRU] radioactive and mixed wastes resulting from defense 
activities and programs of the United States. These materials are 
currently stored at temporary facilities, and until WIPP is opened, 
little can be done to clean up and close these temporary storage sites.
  Idaho currently stores the largest amount of TRU waste of any State 
in the Union, but Idaho is not alone. Washington, Colorado, South 
Carolina, and New Mexico also temporarily store TRU waste.
  The agreement recently negotiated between the State of Idaho, the DOE 
and the U.S. Navy states that the TRU currently located in Idaho will 
begin to be shipped to WIPP by April 30, 1999.

[[Page S6589]]

This legislation will assure this commitment is fulfilled by clearly 
stating that it is the intent of Congress that the Secretary of Energy 
will complete all actions needed to commence emplacement of TRU waste 
at WIPP no later than November 30, 1997.
  We cannot solve the environmental problems at sites such as the Idaho 
National Engineering Laboratory, Rocky Flats Weapons Facility, Savannah 
River and others without WIPP. The reason is obvious. Without a place 
to dispose of the waste, cleanup is impossible, and without cleanup, 
further decommissioning can not occur.
  The goal of this bill is simple: To deliver on Congress' longstanding 
commitment to open WIPP by 1998.
  This bill amends the Waste Isolation Land Pilot Plant Land Withdrawal 
Act of 1992 in several very significant ways.
  It deletes obsolete language in the 1992 act. Of particular 
importance is the reference and requirements for test phase activities. 
Since the enactment of the 1992 act, the Department of Energy [DOE] has 
abandoned the best phase that called for underground testing in favor 
of above ground laboratory test programs. Thus the test phase no longer 
exists as defined in the 1992 law and needs to be removed so it does 
not complicate the ongoing WIPP process.
  Most important, this amendment will streamline the process, remove 
duplicative regulations, save taxpayers dollars--currently the costs to 
simply watch over WIPP exceed $20 million per month.
  This bill does not remove EPA as the DOE regulator of the WIPP. DOE 
has stated numerous times that it does not want to self regulate. The 
Department believes that having EPA as the regulator will instill 
additional public confidence in the certification process and the 
facility itself, once it opens.
  I am skeptical regarding EPA. EPA has a poor record of meeting 
deadlines. The WIPP, as a facility, is ready to operate now and is 
basically waiting on EPA's final approval. The schedule DOE has 
established to meet the opening dates is an aggressive but not entirely 
workable timetable. It is aggressive only if EPA can accomplish its 
tasks on time. Because of EPA's demonstrated inability to meet 
schedules and to avoid imposing unnecessary large financial burdens on 
the taxpayer, there is a strong sentiment in the Congress to remove EPA 
from the WIPP regulatory role. Based on assurance made to me by the 
EPA, my amendment does not follow this course. However, if EPA again 
falters, I will have to reconsider this position in future legislation.
  Idaho and the Nation need to have the WIPP opened sooner rather than 
later. Each day of delay is costly, nearly $1 million per day in 
taxpayers dollars, and the potential dangers to the environment and 
human health resulting from the temporary storage of this waste 
continue.
  It is time to act. We must, if we are to clean up sites such as 
Idaho's. We must act to dispose of this task permanently and safely for 
future generations. This amendment clears the way for action.
  Mr. MURKOWSKI. Mr. President, I would like to ask permission to 
engage in a colloquy with Senator Craig, regarding his amendment to the 
Waste Isolation Pilot Plant Land Withdrawal Act. The WIPP Land 
Withdrawal Act withdrew land near Carlsbad, NM, for construction of a 
disposal facility for transuranic waste produced by the Department of 
Energy. That act was reported out of the Committee on Energy and 
Natural Resources and enacted in 1992. In addition to providing for the 
withdrawal of the land, the WIPP Land Withdrawal Act imposed many 
substantive and procedural licensing requirements on the WIPP facility. 
Many of these requirements are redundant or have become moot as a 
result of changes in the program, and should be eliminated. S. 1402, a 
bill introduced by Senators Craig and Johnston to amend the WIPP Land 
Withdrawal Act, has been referred to the Energy and Natural Resources 
Committee. Does Senator Craig acknowledge that this amendment addresses 
matters within the jurisdiction of the Committee on Energy and Natural 
Resources?
  Mr. CRAIG. Yes, this amendment would alter the language of the WIPP 
Land Withdrawal Act, which is within the jurisdiction of the Committee 
on Energy and Natural Resources.
  Mr. MURKOWSKI. Although this amendment is within the jurisdiction of 
the Committee on Energy and Natural Resources, I support the 
substantive changes made by the amendment and understand that it is 
important to make these changes in a timely manner. Therefore, I will 
not object to its inclusion in the Defense authorization legislation.
  Mr. CRAIG. Mr. President, I now yield to Senator Bingaman from New 
Mexico.
  The PRESIDING OFFICER. The Senator from New Mexico is recognized.
  Mr. BINGAMAN. Mr. President, I do support this amendment. Let me say 
that when this bill was first introduced in the House, and in the 
Senate as well, I felt it was fatally flawed in several respects. It 
did, in its first form, propose to eliminate the regulatory role of the 
Environmental Protection Agency. It proposed to allow nondefense 
transuranic waste to go to WIPP, as well as defense-related transuranic 
waste. It needed the periodic recertification requirement by the 
Environmental Protection Agency. It deleted authority by EPA to issue 
criteria.
  All of those problems have been solved in the amendment that is now 
about to be voted on here in the Senate. I am very pleased to see the 
improvements that have been made. I have been in touch with the Under 
Secretary of Energy, Thomas Grumbly, to get his comments on this 
proposed amendment which we are now getting ready to vote on. He 
indicates that he and his staff have reviewed it in detail and support 
the amendment.
  I have been also in touch with Mary Nichols, the Assistant 
Administrator for Air and Radiation in the Environmental Protection 
Agency. She indicates that she is satisfied with this proposed 
amendment and believes it is something that we should enact.
  Mr. President, the foremost concern that I have had, and that I 
believe most Members have had, in this facility from the beginning has 
been whether or not we were adequately protecting the health and safety 
of our citizens as we went forward to design and develop this 
facility. I am persuaded we are still adequately protecting that health 
and safety, even under this language. For that reason, I will support 
it.

  I will make the point which needs to be crystal clear that 
transuranic waste can only be disposed of underground at this facility 
upon completion, by the Administrator of EPA, of a certification that 
final disposal regulations have been complied with. That essential 
safeguard is foremost in this amendment. I think that is very important 
for the people of New Mexico. I urge my colleagues to support the 
amendment.
  Mr. CRAIG. Mr. President, I yield to Senator Domenici from New 
Mexico.
  Mr. DOMENICI. Mr. President, I thank Senator Craig. Senator Bingaman, 
it is a pleasure to be with you here on the floor on this issue.
  Let me start by reiterating the last comments that Senator Bingaman 
made. What is most important to us, and what is most important to the 
people of New Mexico, is that as this underground facility proceeds to 
the point where it may be opened and finally be a repository, that it 
be subject to the Environmental Protection Agency's most strict 
requirements with reference to health and safety. As a matter of fact, 
they must certify it before it can be opened.
  I will read for the Record an excerpt from a letter dated May 15, 
1996, from the EPA, Mary D. Nichols, assistant administrator for Air 
and Radiation. I ask unanimous consent that the entire communication be 
printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

         U.S. Environmental Protection Agency, Office of Air and 
           Radiation,
                                     Washington, DC, May 15, 1996.
     Hon. Tom Udall,
     Attorney General of New Mexico,
     Santa Fe, NM.
       Dear Mr. Udall: The purpose of this letter is to follow-up 
     on our telephone conversation of April 1, 1996, and respond 
     to your letter of April 4, 1996, regarding the Environmental 
     Protection Agency's (EPA) role in the regulation of the Waste 
     Isolation Pilot Plant (WIPP).
       The Administration is presently formulating its position on 
     H.R. 1663, the ``Skeen-Schaefer Bill'' amending the WIPP Land

[[Page S6590]]

     Withdrawal Act (Pub. L. 102-579). I appreciated hearing your 
     views about the legislation and am pleased we had the 
     opportunity to discuss these important issues. The Agency 
     believes that the amended H.R. 1663 is a sound bill and makes 
     critical improvements over its antecedent. As you are aware, 
     the Skeen Bill, as originally proposed, severely limited 
     EPA's regulatory oversight of WIPP and, we believe, did not 
     provide adequate protection of human health and the 
     environment. Mr. Schaefer's amendments retain EPA as the 
     independent regulator of the WIPP, eliminates extraneous 
     requirements, and leaves intact the provisions of the 1992 
     WIPP Land Withdrawal Act (LWA) that require EPA to certify 
     whether the WIPP facility will comply with the disposal 
     regulations in accordance with public rule-making procedures.
       You specifically expressed concern about the impact of the 
     proposed legislation on the WIPP certification process. In 
     particular, that review of individual chapters of the 
     Department of Energy's (DOE) compliance application by EPA 
     would require the Agency to commit to a position on the 
     sufficiency of each chapter without public input. While it is 
     true that EPA will review individual chapters prior to 
     receipt of the full application, the Agency will make no 
     determination on the adequacy of any part of the application 
     until: 1) EPA has received the full application from the 
     department; and 2) public comments have been considered. 
     In fact, the Agency has received the first of these 
     chapters and placed it in the certification docket (No. A-
     93-02) on May 1, 1996. We will be providing written 
     comments to DOE on these chapters. The written comments 
     will also be placed in the public dockets.
       You also raised concerns about the effect of the proposed 
     legislation on the public's opportunity to provide comment on 
     DOE's application. As in the past, EPA will continue to 
     foster an open public process. As you will note in the final 
     compliance criteria (40 CFR Part 194), EPA will hold two 120-
     day public comment periods after it receives DOE's full 
     compliance application. The proposed legislation will not 
     affect the process established in the compliance criteria. 
     Furthermore, EPA never planned for or created any process for 
     formal public comment on the completeness of the application. 
     Therefore, since DOE is providing the Agency with individual 
     chapters prior to submission of the full application, the 
     public will have an additional opportunity to comment on, and 
     additional time to review, the individual chapters, via EPA's 
     public docket.
       Additionally, you were concerned that the proposed H.R. 
     1663 removes the ability of the Administrator to enforce 
     compliance of the WIPP with any law, regulation or permit 
     requirement described in Sec. 9(a)(1) of the LWA. We feel 
     that EPA's ability to ensure compliance with these 
     environmental laws is not compromised by removal of this 
     provision since: 1) the environmental laws described in the 
     LWA contain their own enforcement provisions; and 2) 40 CFR 
     Part 194 imposes requirements that DOE perform remedial 
     actions if the Administrator determines WIPP to be in non-
     compliance with the transuranic waste disposal standards.
       Further, with regard to H.R. 1663, you expressed concern 
     about the WIPP being used as a repository for transuranic 
     wastes that did not result from a defense activity. The 
     proposed legislation does not alter the definition of 
     exposure or capacity limits of either remote- or contract-
     handled wastes set forth in the LWA. If EPA were to certify 
     the WIPP, this provision would allow for disposal of a 
     relatively small amount of waste from a site in West Valley, 
     NY. If WIPP were capable of accepting this waste within the 
     capacity limits of the LWA, it would be imprudent to 
     needlessly spend taxpayer money for a site similar to WIPP 
     for such a small amount of transuranic waste simply 
     because the process which generated the waste was not 
     defense related.
       Lastly, I am disappointed that you have elected to bring a 
     legal challenge against EPA's WIPP compliance criteria 
     published on February 9, 1996. The EPA considered the views 
     of all interested parties, including the comments and 
     suggestions made by your office, in deciding the contents of 
     the final criteria. As you know, EPA held two public comment 
     periods totaling 135 days, and conducted a series of public 
     hearings in New Mexico. Ultimately, the Administrator of EPA, 
     exercising her independent judgment, determined the contents 
     of the final criteria. We believe EPA's criteria are sound 
     and will effectively protect public health and the 
     environment.
       I want to assure you that EPA will keep communication lines 
     open as it undertakes the public rulemaking proceeding to 
     certify whether the WIPP facility will comply with the final 
     disposal regulations. We recognize the importance of this 
     matter to you and all of the residents of New Mexico.
       If you have questions regarding this letter or any other 
     concerns, please contact Frank Marcinowski of my staff at 
     (202) 233-9310.
           Sincerely,

                                              mary D. Nichols,

                                           Assistant Administrator
                                            for Air and Radiation.

  Mr. DOMENICI. This letter is written to the attorney general of New 
Mexico in response to inquiries. ``The Agency believes that the amended 
H.R. 1663''--I will state here, for all intents and purposes, is the 
Craig amendment--``is a sound bill and makes critical improvements over 
its antecedent. As you are aware, the Skeen bill, as originally 
proposed, severely limited EPA's regulatory oversight of WIPP and, we 
believe, did not provide adequate protection of human health and the 
environment. Mr. Schaefer's amendments retain EPA as the independent 
regulator of the WIPP, eliminates extraneous requirements, and leaves 
intact the provisions of the 1992 WIPP Land Withdrawal Act (LWA) that 
require EPA to certify whether the WIPP facility will comply with the 
disposal regulations in accordance with public rule-making 
procedures.''
  I do not think it can be any clearer that the EPA wholeheartedly 
supports this amendment.
  In summary, the amendment is almost identical to language agreed to 
by DOE and EPA. That agreed-upon language was reported by the House 
Commerce Committee on April 25 and was recently reported by the House 
National Security Committee.
  The legislation would:
  Delete the authorization included in the WIPP Land Withdrawal Act to 
conduct tests underground at WIPP using transuranic waste.
  The DOE decided in 1992 not to conduct such tests.
  Require the Secretary of Energy to acquire the oil and gas leases on 
the WIPP site unless the EPA determines the acquisition is not 
necessary.
  Create an incremental licensing process under which DOE will submit 
chapters of the license application one at a time, and EPA would 
comment one at a time. The EPA would make a final, encompassing 
decision. The EPA could request additional information from the DOE at 
any time.
  At the suggestion of the EPA and DOE, provides that the final 
disposal regulations for WIPP will be the radiation protection 
standards at 40 C.F.R. 191, and not the Solid Waste Disposal Act.
  The WIPP Land Withdrawal Act required that DOE certify compliance 
with both, a step DOE and EPA agreed would be redundant.
  The legislation allows the DOE to use engineered barriers, natural 
barriers, or any other measures--this last provision being a new 
provision--to ensure WIPP complies with the final disposal regulations.
  This allows DOE to use waste treatment, such as vitrification, to 
ensure WIPP's compliance.
  Deletes the section of the WIPP Land Withdrawal Act dealing with 
retrieval of the waste emplaced during the test phase since no waste 
will be emplaced during a test phase.
  States that it is the intent of Congress that the Secretary of Energy 
make a final decision with respect to the disposal of transuranic waste 
at WIPP by November 30, 1997.
  Provides $20 million per year to New Mexico for impact assistance 
beginning upon enactment of this legislation.
  The waste isolation pilot plant is a permanent disposal facility in a 
salt bed 2,000 feet below New Mexico for transuranic waste generated in 
DOE's nuclear weapons complex.
  Transuranic waste means waste that includes both radioactive material 
and solvents, metals, and other refuse from manufacturing.
  The WIPP Land Withdrawal Act enacted on October 30, 1992, authorized 
a 5- to 8-year test phase at WIPP during which transuranic waste could 
be placed in WIPP and monitored.
  Because of the nature of the waste intended for WIPP, the act also 
made WIPP subject to two sets of regulations: radiation protection 
standards and the Solid Waste Disposal Act.
  In 1993, DOE decided it was not necessary to conduct underground 
tests at WIPP using transuranic waste.
  At the suggestion of DOE and EPA, this amendment makes the WIPP Land 
Withdrawal Act consistent with the current test phase at WIPP and 
removes the redundancy of two sets of regulatory standards.
  First, the amendment deletes those sections of the WIPP Land 
Withdrawal Act dealing with tests using transuranic waste.
  Second, the amendment, at the suggestion of the EPA, subjects WIPP to 
the radiation protection standards and removes the application of the 
Solid Waste Disposal Act. This is necessary to remove the confusion 
that occurs by imposing two different sets of regulations.

[[Page S6591]]

  Frankly, it is clear that WIPP can meet with Solid Waste Disposal 
Act, its 10,000-year radiation protection standards are going to be the 
real challenge and the relevant regulations.
  There are two centers of controversy in that law. First, what hurdles 
did DOE have to overcome to use transuranic waste for tests in WIPP. 
And second, what information had to be revealed by those tests for a 
final disposal decision to be made.
  DOE subsequently decided that tests with transuranic waste were not 
needed.
  These changes primarily deal with taking out those provisions of the 
law dealing with tests using transuranic waste.
  The law also required WIPP to meet two different standards for the 
disposal of waste at WIPP: radiation release standards and solid waste 
standards.
  DOE and EPA now agree that demonstrating compliance with both 
standards is redundant--they agree compliance is best proven by meeting 
the radiation release standards.
  The original law also provided New Mexico $20 million per year 
beginning in the first year transuranic waste was shipped to WIPP. The 
money was to be used for roads and other improvements.
  Because no transuranic waste has been brought to WIPP for the tests, 
New Mexico has lost out on $160 million that would have otherwise been 
provided. This law starts the flow of that money immediately so New 
Mexico can make the necessary road upgrades.
  I indicate to the Senate that it is clear this waste isolation pilot 
project, one of a kind, the first ever, can meet the requirements of 
the Solid Waste Disposal Act. It is not that act that is cumbersome and 
difficult to achieve, but rather the 10,000-year radiation protection 
standards. Let me repeat: 10,000-year radiation protection standards. 
These are the standards that are going to be in effect after this 
amendment is adopted and becomes law. They are in effect now.
  All we are suggesting is the EPA and the Department of Energy thinks 
this is the only set of standards that we need follow and that those 
that are found under the Solid Waste Disposal Act are redundant and not 
needed in this case.
  I thank all who have cooperated in getting us this far. It is time to 
get this done. This amendment has been reported out on April 25 from a 
House committee and was reported recently by the National Security 
Committee in the House. It has had hearings and been looked at over and 
over by the regulatory agencies. I believe it is time to adopt it.
  I yield the floor.
  Mr. THURMOND. Mr. President, I rise in favor of this amendment. It is 
very similar to WIPP legislation introduced last year in the House. 
That legislation was agreed to by the Department of Energy and 
Environmental Protection Agency and goes a long way toward breaking 
down the regulatory log jams that are holding up this much needed 
facility.
  The story of WIPP is a story of false starts and needless delays. The 
delays in opening WIPP have created a massive backlog of materials that 
are currently being stored at DOE sites throughout the country--often 
in drums and boxes--at a very high cost to the taxpayers. These wastes 
need to be stabilized and prepared for shipment to a permanent and safe 
repository. The WIPP facility provides a safe and permanent disposal 
option and we should move forward as rapidly as possible with its 
opening.
  Mr. President, we need this facility. We need it now. This amendment 
will help move this facility forward and I wholeheartedly support its 
passage.
  Mr. KEMPTHORNE. Mr. President, I am pleased to introduce and support 
the Craig-Kempthorne-Domenici-Bingaman amendment relating to the WIPP 
land withdrawal. The proposed amendment will simplify the land 
withdrawal process in a number of important ways. For example, the 
amendment will reduce the waiting period between the final 
certification and opening of WIPP from 180 days to 30 days, improve 
interaction between the Department of Energy and the Environmental 
Protection Agency, remove duplicative regulatory requirements, save the 
taxpayers money, expedite the opening of WIPP, and protect the 
environment, health, and safety of the citizens of New Mexico. In 
addition, the amendment is similar to a legislation in the other body 
which is supported by the Department of Energy and the Environmental 
Protection Agency. This is a good bipartisan amendment, supported by 
the administration, and I am pleased to be a cosponsor of this 
important piece of legislation.
  The WIPP facility plays an important role in our Nation's effort to 
show its citizens that we can deal responsibly with the nuclear waste 
left over from our victory in the cold war. The WIPP facility will 
serve as a permanent repository for transuranic waste. The waste will 
be entombed in a salt cavern that slowly seals itself over time. I have 
visited the WIPP facility and I met with numerous local and State 
officials from New Mexico who strongly support this project.
  THe WIPP facility will also allow the Federal Government to meet its 
court-enforceable commitment to the State of Idaho to ship transuranic 
waste from Idaho by 1999. The proposed amendment will help ensure the 
opening of this important facility in time to meet this commitment. 
WIPP will serve as a symbol of our ability to dispose of nuclear 
material in a safe and rational way.
  I want to thank the two able Senators from New Mexico, Senator 
Domenici and Senator Bingaman, for their help in drafting this 
bipartisan amendment. I also want to thank Senators Murkowski and 
Johnston, chairman and ranking member of the Energy Committee, for 
their support for this important amendment.
  Mr. CRAIG. Mr. President, let me close by thanking all of my 
colleagues for the cooperation and their participation in getting this 
amendment to the floor. Without the help of Senator Domenici and 
Senator Bingaman, this amendment would not be here today. They are the 
host States, but they have also been extremely diligent in assuring the 
citizens of their State that once this is in place, it is 
environmentally sound and certainly protects, in all ways, their 
citizens.
  In my State of Idaho, the Governors' agreement is now negotiated and 
completed by a Federal court order. It could not go forward without 
this amendment. Now we have this amendment in place, protecting all of 
the environmental concerns involved, solving many of the environmental 
problems we have in our State.
  Let me thank my colleagues for their participation. I ask that the 
amendment be adopted.
  The PRESIDING OFFICER. If there is no further debate, the question is 
on agreeing to amendment No. 4085, offered by the Senators from Idaho 
and New Mexico.
  The amendment (No. 4085) was agreed to.
  Mr. CRAIG. I move to reconsider the vote.
  Mr. THURMOND. Mr. President, I move to lay that motion on the table.
  The motion to lay on the table was agreed to.
  The PRESIDING OFFICER. Under the previous agreement, the Senator from 
Arkansas is now recognized.


                Conforming Amendment to GATT Legislation

  Mr. PRYOR. Mr. President, I will take a very few moments this 
afternoon to refresh my colleagues' memories as to why we are here 
again to act on the GATT issue.
  When the Congress passed the GATT legislation, we made two changes to 
U.S. patent law. First, all patents were extended from 17 to 20 years 
in length. That is the law today for all patents in every industry in 
this country.
  Second, we adopted a grandfather provision which permitted generic 
competitors in all industries to go to the market on the original 17-
year date if they had made a substantial investment and if they paid a 
royalty to the patent holder.
  But according to the U.S. Trade Representative, the Food and Drug 
Administration, the Department of Health and Human Services, and the 
Patent and Trademark Office, the Congress accidentally--and I underline 
``accidentally''--omitted a conforming amendment in the GATT 
legislation. The Congressional Record also documents our very clear 
intent to apply the GATT treaty universally without any special 
exceptions.
  Mr. President, as a result of our error and this missing amendment, a 
single

[[Page S6592]]

industry has now been exempted from the GATT grandfather provision. 
Every single product, every company, and every industry in this country 
abide by this law today, except for one particular industry. That is 
the prescription drug industry.
  The omission of this single industry has created a loophole that 
benefits just a few drug companies, especially Glaxo Wellcome. The 
loophole, Mr. President, in the GATT legislation has given them a $2.5 
billion windfall. That's $5 million a day. As long as we wait and talk 
and do nothing, these few drug companies are receiving millions every 
day which are subsidized by the elderly, by the veterans and by the 
consumers of America. Today, we have an opportunity to put this to an 
end. We could bring equity at long last to this issue.
  Glaxo Wellcome is the largest drug firm in the world. It is today 
receiving a lion's share of this multibillion dollar windfall through 
the world's best-selling drug, Zantac.
  Today, generic competitors to Zantac who have already made a 
substantial investment and readied their products for the market have 
been unintentionally denied access to the marketplace. Today, they have 
idled their factories and their workers wait for us to act. Today, the 
consumers of America are being denied cheaper prices for their drugs 
which they should have received months ago.
  The amendment that I offer today, Mr. President, on behalf of Senator 
Brown, Senator Chafee, and Senator Bryan, is simply the conforming 
amendment which should have been a part of the GATT legislation. This 
is our opportunity to fix a glaring legislative mistake. In the 
process, we will save American consumers literally billions of dollars, 
and we will bring our country into full compliance with our treaty 
obligations.
  Let me remind my colleagues how our friend and colleague, Senator 
Paul Simon of Illinois, recently summed up this issue. He said: ``This 
is as classic a case of public interest versus special interest as you 
could find.''
  Last December, we brought this amendment to the floor and 
unsuccessfully sought an up-or-down vote on it. There was an effort to 
kill the amendment with a sense-of-the-Senate resolution that called 
for a hearing in the Judiciary Committee. When we withdrew the 
amendment from consideration, we promised, like General MacArthur, to 
return.
  But there have been many delays and postponements in the last several 
months and procedural obstacles thrown up by our opponents. For some 
mysterious reason, the hearing that was promised took more than 2 whole 
months to schedule. A markup was promised for March. It was postponed 
three different times for over a month.
  Mr. President, here is the price for our opponents' delay. Here is 
the price that American consumers are paying and putting into the 
pockets of a few drug companies. As a result of our delay, a few 
companies have collected $990 million as a windfall. We are just 2 days 
short of permitting this to grow into a round $1 billion windfall, a 
windfall which continues because of a congressional mistake we have 
still not corrected.
  We have waited and waited and waited, while the Judiciary Committee 
held a hearing and markup. The result of all this delay is that now the 
record simply verifies that a costly mistake has been made which needs 
correction. Ambassador Mickey Kantor, then our Trade Representative, 
testified at the hearing that our amendment ``would do nothing more 
than fulfill our obligation to be faithful to what we had negotiated in 
the GATT treaty.'' He confirmed that it ``would carry out the intent, 
not only of the negotiations and what the administration intended, but 
also what the Congress intended.''
  When the Judiciary Committee marked up the GATT amendment, it 
regrettably ordered and reported out a fatally flawed substitute 
version. According to a letter from the Department of Health and Human 
Services which has been distributed to each Member of the Senate, the 
FDA and the Department concluded that the Judiciary or Hatch substitute 
does not close the loophole. In fact, it would be virtually impossible 
for a manufacturer to obtain FDA approval under the substitute.
  To add insult to injury, Mr. President, the substitute version 
includes a veritable treasure trove of patent extensions and special 
breaks for other drug companies that are completely unrelated to the 
GATT loophole. So we have all waited endlessly, enriched a few 
companies and ended up with a substitute which is worse than the status 
quo.
  I would add, Mr. President, that the committee marked up on May 2. 
The committee has yet to file a report on the substitute version. In 
fact, the committee also has guaranteed we delay for months the 
consideration of our amendment. Moreover, I understand the 
distinguished committee chairman, Senator Hatch, will offer the 
substitute version as a second-degree amendment to our own and further 
delay consideration.
  Mr. President, the only compromise in the committee's work is a 
compromise of the interests of consumers and our Nation's vital health 
care programs--Medicaid, Defense Department and CHAMPUS, VA, Public 
Health and Indian Health Service clinics, private health insurers, and 
the like.

  We have a very clear choice before us this afternoon. We can do the 
right thing. We can do the right thing by voting for this amendment. We 
can do the right thing by defeating the substitute version offered as a 
second-degree amendment by the distinguished chairman of the committee, 
the Senator from Utah.
  Many have asked me, Mr. President, why we are offering this amendment 
on the Department of Defense authorization bill. There is a very simple 
answer. First, this amendment would save the Department of Defense over 
$30 million. The Department of Defense has estimated that it spends 
$900 million a year on prescription drugs for our servicemen, 
servicewomen, and their families. According to estimates consistent 
with earlier CBO estimates for Medicaid savings, our GATT amendment 
would cut those expenditures by over $30 million.
  Mr. President, for this reason alone, we think this is a proper place 
to bring this amendment to the attention of our colleagues with the 
intention of receiving their consideration and, hopefully, a positive 
vote.
  I also want to summarize, if I might, Mr. President, what I think may 
become a second-degree amendment to the Pryor-Chafee-Brown-Bryan bill. 
First, the Department of Health and Human Services, as I have 
mentioned, has analyzed the substitute. They concluded that ``it does 
not close the GATT loophole'' and includes legal requirements that are 
``nearly impossible to meet'' and ``present nearly insurmountable 
obstacles'' to fair competition.
  Second, the substitute was originally drafted by the brand name drug 
industry association, PHRMA. We have a copy of the PHRMA draft. As 
PHRMA wrote, the substitute ``protects the interests of PHRMA 
members''--not consumers, and certainly not taxpayers.
  As a result, Mr. President, the Hatch amendment that we may be 
considering--which looks like a Rube Goldberg design as far as judicial 
procedure is concerned--may be described better as a Christmas tree. It 
is a Christmas tree of special interest favors, new multimillion dollar 
patent extensions and provisions intended to overturn Federal court 
decisions. This Christmas tree preserves the GATT loophole. It blocks 
generic competition. It protects the Glaxo windfall. It overturns the 
Federal courts. It guarantees endless litigation. It rewards companies 
like Merck, Zeneca, and Wyeth with millions in special protections 
without giving my colleagues and I a single credible legal or policy 
justification.
  Finally, Mr. President, Professor Leo Levin, professor emeritus of 
law at the University of Pennsylvania, is one of the world's leading 
experts on the problems of cost and delay in civil litigation. I 
thought it would be interesting if we mentioned the opinions of 
Professor Levin, the former director of the Federal Judicial Center. 
Here is what Professor Levin thinks of the Hatch substitute:

       My conclusion is that, conservatively, I would expect 
     several years to elapse from the commencement of litigation 
     under the Hatch substitute until final disposition on appeal.
  In other words, this is an ironclad guarantee to Glaxo and its 
compatriots that they can collect their entire $2.5 billion windfall. 
It is an ironclad guarantee that competition will be 

[[Page S6593]]

locked out and that windfall profits flow to the wrong parties.
  There is also a sense-of-the-Senate provision in the Hatch substitute 
which purports to urge parties to litigate quickly. I am sure my 
colleague from Utah will say this is a godsend; that it will somehow 
compel the parties to go to court and resolve their differences quickly 
so that we can have free and orderly competition.
  Here is what Professor Levin concluded about that particular sense-
of-the-Senate resolution embodied in the Hatch substitute:

       This is a laudable sentiment but without legal impact. In 
     short, it evidences recognition of the problem but not an 
     effective solution to the problem.

  Mr. President, I could talk on and on about this issue. I do not 
think we need to talk a lot longer about it. I would like to say that I 
would enjoy proceeding, if we could. I would be more than happy to 
enter into an agreement on time. I have not actually sent the amendment 
to the desk. I will do so at the appropriate time. But I see my 
colleague from Utah standing. I wonder if he has any comment.
  Mr. HATCH addressed the Chair.
  Mr. THURMOND addressed the Chair.
  The PRESIDING OFFICER. The Senator from South Carolina is recognized.
  Mr. THURMOND. Mr. President, do we have a time agreement?
  Mr. PRYOR. We do not have a time agreement. I am more than willing to 
enter into a time agreement for a vote on our amendment to take place.
  Mr. THURMOND. What does the Senator suggest as a time agreement?
  Mr. PRYOR. Mr. President, I suggest that we have no more than an 
hour, or perhaps even a 45-minute time agreement. I would like to 
inquire of my friend from Utah whether this is agreeable.
  Mr. HATCH. We are agreeable to 45 minutes.
  Mr. THURMOND. Equally divided?
  Mr. PRYOR. I am just proposing that.
  Mr. HATCH. It is my understanding that Senator Pryor has an 
amendment. I believe the Senator from South Carolina will second degree 
the amendment. I will agree to a 45-minute time limit divided equally 
on both amendments in order to accommodate my colleague, even though I 
think I need almost a half-hour to speak on it. But I will agree to 45 
minutes.
  Mr. SPECTER. Reserving the right to object, Mr. President.
  The PRESIDING OFFICER. There has been no unanimous consent offered.
  Mr. HATCH. Is the time limit we discussed agreeable to my colleague?
  Mr. PRYOR. I would like to make two requests. One, before I agree to 
such a proposal, I would like to see the amendment in the second 
degree. I think it would be only fair because the Senator from Utah has 
had our amendment for many, many months. Second, I would like to ask, 
should we agree to a time agreement, that I may be immediately 
recognized should my amendment be tabled or should the second-degree 
amendment prevail.
  Mr. HATCH. I did not hear your whole sentence. Your amendment to be 
what?
  Mr. PRYOR. Should the Hatch amendment be agreed to. I should phrase 
it that way.
  Mr. HATCH. Would the Parliamentarian please state what the offer was?
  Mr. THURMOND. Mr. President, could we pause long enough to let him 
send the amendment to the desk?
  The PRESIDING OFFICER. Would the Senator from Arkansas wish to 
restate the last point that he made?
  Mr. PRYOR. Mr. President, I would like to put in a unanimous consent 
request, that should the Hatch second-degree amendment prevail--and I 
not get the vote on my amendment--that I might be immediately 
recognized for an up-or-down vote on my amendment.
  Mr. HATCH. If we prevail?
  Mr. PRYOR. I would simply reoffer my amendment, and I would like to 
be recognized for that purpose. And I ask unanimous consent.
  Mr. HATCH. If we win, we win; if we lose, we lose. But we prefer to 
do it in the routine parliamentary fashion.
  Mr. PRYOR. Mr. President, that is precisely what I seek. If I may, I 
think we can resolve this together if I may respectfully suggest the 
absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The assistant legislative check proceeded to call the roll.
  Mr. HATCH. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. HATCH. Mr. President, I ask my dear friend from Arkansas to 
correct me if I misstate this. It is my understanding that Senator 
Pryor will neither offer his amendment today, nor does he believe 
anybody else will offer a similar amendment today. We will save the 
vote for another day, but we will each make a few comments today.
  Mr. PRYOR addressed the Chair.
  The PRESIDING OFFICER. The Senator from Arkansas.
  Mr. PRYOR. Mr. President, under the circumstances--and the 
circumstances are these--I have been waiting since January to offer 
this amendment. I think, as a Member of this body, I am entitled to 
have a vote on this amendment. Maybe it is a tabling motion. I am not 
objecting to that. But I think on this particular amendment and on this 
language, this Senator is entitled to this body deciding, yes, we do 
want this amendment or, no, we do not.
  That is all I have asked for all year. It is all I am asking for now. 
It is apparent I am not going to get that, so I am not going to send up 
an amendment at this time, and I will wait until next week or I might 
wait until next July or I might wait until next September, whenever. 
But I am going to offer this amendment, and I hope to get a vote on it. 
I hope my colleagues will allow me to get a vote on it. I have never 
second degreed an amendment here in 18 years--never. In fact, I have 
never even been tempted to. And I am not going to second degree my own 
amendment. I am not going to get cute, parliamentarily speaking. I hope 
my colleague from Utah will understand and the managers will 
understand, but I just do not think it is protecting of my rights now 
to offer an amendment.
  If I may, I would like to ask unanimous consent to add a few 
cosponsors: Senator Byrd, Senator Dorgan, and Senator Leahy, all to be 
original cosponsors.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. PRYOR. Mr. President, I thank the Chair.
  Mr. HATCH. Mr. President, I am prepared to put this to a vote today. 
As I understand it, if the Senator had called up his amendment, then 
the distinguished Senator from South Carolina would have called up his 
second-degree amendment, which is certainly both legitimate under the 
rules and a common practice in the Senate whenever we have some of 
these very sensitive, difficult matters to consider.
  Let me say this, Mr. President. I admire my colleague from Arkansas. 
We have been friends for years. He feels very deeply about this.
  But there are many of us who feel very deeply about our side of the 
issue.
  When the time comes, I will ask my colleagues to vote against the 
Pryor amendment and to vote for the compromise legislation on the GATT/
Pharmaceutical patent issue that was recently adopted by a bipartisan 
vote of the Senate Judiciary Committee.
  I know many here are asking themselves how many times are we going to 
have to debate this issue? And, for that matter, they are asking why we 
are considering it on an underlying bill that is, at best, only 
tangentially related to the subject matter of our amendment.
  We considered the Pryor amendment in the Finance Committee last fall 
as part of the budget reconciliation bill, and the committee rejected 
it.
  We considered the amendment on December 7 as an amendment to the 
partial-birth abortion ban bill, and the amendment was not adopted.
  My colleagues attempted to offer the bill as an amendment to the 
Kassebaum-Kennedy health insurance bill, and it was withdrawn.
  In counterpoint to the efforts of Senator Pryor, the Judiciary 
Committee held a February 27 hearing, as I promised.
  On May 2, we held a markup, as I promised.
  We wanted to hold the markup before then, but consideration of the 
immigration bill took longer than anyone anticipated.
  The point is that we held the markup, and we did it in as expedited a 
fashion as possible.

[[Page S6594]]

  I am pleased to say that, with the support of Senators Specter and 
Heflin, we were able to forge a bipartisan compromise that was adopted 
on a 10-to-7 vote.
  We are working hard to file a report on this bill. We do not yet have 
the CBO on-budget estimates, nor do we have their newly required off-
budget, unfunded mandates analysis.
  In short, to bring the Pryor-Brown-Chafee amendment up at this time 
would be to attempt to short-circuit the process that is well underway 
in the Judiciary Committee.
  Senator Pryor's amendment is nothing more than an effort to engender 
support for an approach that the Judiciary Committee has already 
considered and rejected.
  And while my preference would be to consider the Judiciary Committee 
compromise as a freestanding measure, it is clear such will probably 
not be the case.
  I have been around this body long enough to know that you cannot 
always pick the time and place for a debate. If today is the day, so be 
it.
  I thank my colleague for accommodating me in bringing it up at this 
time and giving me notice. I hope that in the future we can notify each 
other on this and, as always, treat each other fairly.
  I also hope that a great majority of my colleagues will agree with me 
that the Pryor amendment is unwarranted and that the Judiciary 
Committee compromise that Senator Thurmond will offer should be adopted 
by the Senate.
  Before I describe why I think the Judiciary Committee compromise is 
preferable to the Pryor amendment, I just want to recognize the fact 
that many in this body have spent a considerable amount of time on this 
somewhat arcane but very important subject.
  Although I firmly disagree with Senators Brown, Pryor, and Chafee on 
this matter, I respect each of them. They are good Senators. Frankly, I 
would prefer working together with them rather than in opposition.
  In fact, despite our sharp differences on this particular issue, 
Senators Pryor, Chafee, and I are working closely together on the 
Finance Committee to ensure adequate funding of community health 
centers and rural health clinics.
  I will miss debating David Pryor on these tough and complex 
pharmaceutical issues when he retires from the Senate later this year. 
The same is true for Hank Brown, our good friend.
  I will also miss Senator Heflin, a great friend who has been on the 
Judiciary Committee almost as long as I have. He studied this issue 
carefully as well. I fully agree with the observation he made at one of 
our recent Judiciary Committee hearings that the generic and innovator 
segments of the industry have much more in common than they have in 
contention. I was particularly pleased that Senator Heflin voted for 
the Judiciary Committee compromise, although he voted with Senator 
Pryor last December.
  I also wish to commend especially my colleague from Pennsylvania, 
Senator Specter, with helping to develop the Judiciary Committee 
compromise proposal. He played a critical role in this effort. I want 
everyone to understand how much the other members of the Judiciary 
Committee and I value his leadership in this area.
  The issue we are debating today centers on the complex 
interrelationship between the GATT treaty, the Federal Food, Drug, and 
Cosmetic Act, and the Patent Code. In particular, the question is how 
certain transition rules contained in the Uruguay Round Agreements Act 
apply to pioneer pharmaceutical patents which have been extended by the 
URAA.
  This is a tough, contentious issue. That is because there is an 
inherent tension involved in setting and adjusting the incentives that 
will result in both the next generation of breakthrough therapies and 
in making low-cost generic equivalents available. The American people 
need both breakthrough innovator products and lower cost generics.
  But as former Surgeon General Dr. C. Everett Koop has wisely 
observed:

       ``. . . we must resist the temptations of short-term 
     thinking and look at the big picture. The only way to make a 
     real difference in health care costs--and a real 
     difference in people's lives--is to find cures for AIDS, 
     cancer, Alzheimer's and . . . other diseases. The way to 
     do that is to encourage support for medical innovation.

  And make no mistake that retaining incentives for biomedical research 
is exactly what the Judiciary Committee compromise does.
  I am extremely pleased to tell my colleagues that Dr. Koop spoke to 
my staff this morning and said that he is supportive of the Judiciary 
Committee compromise that I am offering today.
  Let me outline the key elements of the Judiciary Committee compromise 
proposal that I developed, working, as I have said, in close 
consultation with Senator Specter who has a very deep interest in this 
issue.
  This is important, to lay this out, so people realize it is not quite 
as simple as the distinguished Senator from Arkansas articulates here 
on the floor today.
  The compromise allows generic drug applications which were submitted 
to the FDA by June 8, 1995, and were found to be sufficiently complete 
so as to permit substantive review to be approved for marketing during 
the GATT transition period.
  As with other industries under the URAA, a court must first determine 
that the generic drug manufacturer met the substantial investment 
requirement.

  This investment could not solely consist of expenditures related to 
the development and submission of an abbreviated new drug application, 
or ANDA.
  Under the Judiciary Committee compromise, the court would take into 
account activities that were specifically related to the research, 
development, manufacture, sale, and marketing, and other activities 
undertaken in connection with the specific generic drug application.
  The Judiciary compromise also includes a provision advocated by 
Senator Biden, to treat patents in force on June 8, 1995, as a result 
of a Hatch-Waxman restoration extension in the same manner as other 
patents with respect to URAA patent term modifications.
  This is fair and warranted given the fact that Hatch-Waxman 
restoration extensions are granted in partial compensation for time 
lost due to FDA regulatory review and should be considered wholly 
independent from any URAA extension.
  Finally, at the request of Senator Specter, the Judiciary Committee 
contains a 2-year marketing exclusivity extension for Lodine, a 
nonsteroidal antiinflammatory product. This product was under FDA NDA 
review for over 8 years, and presents a factual case in many respects 
similar to Daypro, which was recently afforded equitable relief in the 
continuing resolution that was passed in April.
  In addition, the proposal contains sense-of-the-Senate language to 
urge that litigation be concluded as expeditiously as possible. In this 
regard, let me just add that Senator Specter will work with me to add 
an amendment that will help us to get there.
  As a matter of fact, under the Judiciary Committee compromise, the 
interest of ensuring prompt litigation is promoted by granting the 
courts the authority to award equitable compensation from the patentee 
to the generic drug applicant in consideration for marketing time lost 
due to litigation.
  The message here is simple and clear: Equity is a two-way street.
  Pioneer drug firms unjustifiably drawing out litigation will be 
placed in substantial financial risk if it is determined by the court 
that equity so requires compensation be paid to the generic 
manufacturer.
  These provisions would not apply to products whose patents would have 
expired, including any restoration periods under the Hatch-Waxman Act, 
after June 8, 1998. The purpose of this provision is to prohibit 
obvious gaming of the system by those who may have submitted generic 
drug applications far in advance than would have been the case in any 
normal commercial transaction.
  It will be interesting to see once CBO completes its analysis of the 
FDA data whether some generic firms may have submitted applications for 
products whose patents expire sometime early in the next century. This 
hardly strikes me as the type of good-faith activity that seems to be 
contemplated by the URAA transition rules.

[[Page S6595]]

  The Judiciary Committee compromise is fair and balanced. I urge all 
of my colleagues to support it.
  I would next like to take just a few moments to explain why I believe 
that this approach is preferable to the Pryor amendment.
  As I have stated on a number of occasions, I have several threshold 
concerns about the Pryor legislation.
  First, it undermines the incentives for biomedical research. Dr. Koop 
and other leading public health experts recognize that it is only 
through research that great life-saving and cost-saving medical 
advances flow. Plain and simple, more research will be conducted under 
the Judiciary Committee compromise than under the Pryor amendment.
  Second, it sets a poor, first example on GATT and will act to 
encourage our trading partners to drag their feet in implementing the 
intellectual property provisions of the GATT Treaty. I know the U.S. 
Trade Representative under the Clinton administration takes a different 
view but I think former Trade Representative Bill Brock got it exactly 
right, and I ask unanimous consent that his remarks be printed in the 
Record.

  There being no objection, the remarks were ordered to be printed in 
the Record as follows:

       It will be difficult, if not impossible, for the United 
     States to force other nations to adhere to the TRIPS 
     agreement if we set this unfortunate precedent. In sum, in 
     exchange for the hope of short term savings, the Pryor 
     proposal could cost all U.S. firms and workers the enormous 
     long term gains we worked so hard to achieve in the Uruguay 
     Round. That is penny wise and pound foolish.

  Mr. HATCH. Third, it may subject the Federal Treasury to substantial 
financial liability under the takings clause of the fifth amendment. On 
this last point, let me just say that the takings issue was discussed 
at our February hearing. I was very interested to learn that analysts 
at CBO have independently raised this issue, so I think it is a very 
real concern. We should attempt to ensure that it is the generic drug 
manufacturers and pioneer pharmaceutical firms, respectively, who are 
financially responsible for paying any court-ordered equitable 
remuneration and equitable compensation.
  In addition to these three major policy concerns that I have just 
outlined, I also take strong exception to the manner in which Senator 
Pryor has attempted to characterize this debate. There are two basic 
arguments that are repeatedly advanced as justification for the Pryor 
amendment.
  The first is the uneven playing field argument. You have heard it 
many times in this debate. Somehow only the generic drug industry has 
not been able to take advantage of the GATT transition rules.
  But the truth of the matter is that there are no reported cases of 
any generic product manufacturer, from any other industry reaching, or 
for that matter even seeking to reach, the marketplace through the 
transition rules. If adopted, the Pryor amendment would tilt the 
playing field by creating a virtually industry-wide advantage being 
granted to only one industry--the generic drug industry. This can 
hardly be called leveling the playing field.
  The other major argument advanced by the proponents of the Pryor 
amendment is the alleged unintentional mistake argument. It is said 
over and over again by my opponents in this debate that adopting the 
Pryor amendment merely amounts to making a technical correction to 
achieve an effect that Congress intended all long.
  I must say that on the surface this argument has a certain amount of 
appeal and is easy to understand. The trouble is that it is simply not 
the borne out by the facts.
  It is important for everyone in this body to understand what the 
Court of Appeals for the Federal circuit found on intent issue last 
November in the Royce case. Frankly, what they found was that, with my 
apologies to Gertrude Stein, ``there is no there, there.'' The court 
said:

       The parties have not pointed to, and we have not 
     discovered, any legislative history on the intent of 
     Congress, at the time of passage of the URAA, regarding the 
     interplay between the URAA and the Hatch-Waxman Act.

  There have been many attempts to create after-the-fact legislative 
history--and additional attempts will no doubt be fabricated in the 
course of our debate today. But, as with the judges on the Federal 
Circuit, I am aware of no evidence at the time of passage of the URAA 
that dispositively resolves, or even hints at resolving, the intent 
issue in the manner now so frequently, so cavalierly, and--it must be 
stated--so misleadingly, claimed by my opponents. I know where the bald 
assertions are but where is the beef? What is this evidence?
  Frankly, the intent argument is somewhat galling. How many times has 
this body debated a supposed technical correction measure, like we did 
for three hours last December, only to refer the matter back to 
Committee for further study by a razor thin 49 to 48 vote. Technical 
correction, my eye.
  I am also greatly concerned that the Pryor approach contemplates 
market entry prior to an opportunity for court resolution of the key 
determinations surrounding substantial investment and equitable 
remuneration.
  A key principle of the Hatch-Waxman Act, and of section 154(c) of the 
URAA, is to first determine the rights of the patent holder before a 
generic competitor may enter the market.
  This principle should not be casually set aside.
  In contrast to the Pryor amendment, the Judiciary Committee 
substitute--consistent with the longstanding paragraph 4 certification 
process under the Hatch-Waxman Act and the plain language of section 
154(c)--would respect the innovator's intellectual property by first 
resolving the substantial investment and equitable remuneration issues.
  In this regard, I must register my objection to the recent June 13 
letter from Secretary Shalala that seems to interpret the language of 
section 154(c)(3) as allowing the continuation of infringing activities 
while the courts resolve the substantial investment and equitable 
remuneration issues.
  This interpretation would be, in my estimation, rejected by the 
courts because it amounts to de facto compulsory licensing. The 
protection of prior judicial review is critical.
  One of the key reasons why our Nation endorsed the intellectual 
property provisions of the GATT Treaty--the so-called TRIPS 
provisions--was to limit the ability of our trading partners to 
wrongfully devalue American intellectual property through compulsory 
licensing provisions.
  This June 13 administration embrace of compulsory licensing may open 
up a real can of worms and will send a horrible signal both overseas 
and to our inventor community here at home.
  I have taken too long, I understand. Let me close by simply saying 
that for the reasons I have given, I hope that my fellow Senators will 
agree with me that the best course is for the full Senate to adopt the 
Judiciary Committee compromise. It was hard fought and won in the 
Judiciary Committee.
  It is a fair compromise and one that will benefit the health of the 
American people and the American public.
  Last, but not least, let me just say this: As the author of the 
Hatch-Waxman bill, this is a very important issue for me. This is 
something that I believe in or I would not be doing this.
  I have been vilified and mistreated and my efforts mischaracterized 
on this issue. I can live with that, because that has happened to me 
many times in my political career, as well as to many others here. But 
I really resent having the issues in this matter mis-characterized in 
the way some people have done.
  I want to say that the generic industry, by and large, has been very 
fair to me and very decent. I personally appreciate them. I look 
forward to trying to help them in the future on issues on which they 
deserve to have help. Unfortunately, this does not happen to be one of 
those issues.
  I hope our colleagues will pay attention to the things that have been 
said on the floor.
  Mr. DODD. Mr. President, I rise today in support of the compromise 
that the Senator from Utah and chairman of the Judiciary Committee, 
Senator Hatch, has offered on the GATT pharmaceutical patent issue. I 
commend him for his leadership on this subject--a subject that is 
fundamentally an intellectual property issue and that is clearly in the 
purview of the Senate Judiciary Committee.
  This is not the first time we have had this discussion. Earlier this 
year, the

[[Page S6596]]

Senator from Arkansas agreed to allow the Senate Judiciary Committee to 
consider this issue. On February 27 and March 5, the committee held 
hearings on this issue with a balanced set of witnesses, and reported 
out a compromise bill on May 2, 1996, on a bipartisan vote of 10 to 7.
  The Judiciary Committee bill would allow the FDA to approve a generic 
drug for marketing prior to expiration of the GATT patent extension, 
but only after a generic drug manufacturer complied with requirements 
spelled out in both the GATT implementing law and the generic drug 
approval process in the 1984 Hatch-Waxman law.
  Under this compromise, generic drug manufacturers would not be 
treated differently than any other generic manufacturer. Like other 
generic manufacturers, generic drug manufacturers would be required to 
prove in court that they had made a substantial investment in their 
product before June 8, 1995. Court determination of substantial 
investment and the establishment of equitable remuneration to the 
patent holder is required under the GATT implementing law prior to 
generic infringement of patents in all industries.
  A generic drug company would have to make substantial investments in 
purchasing land, building a plant, or other capital investments 
comparable to what generic companies in other industries would have to 
make in order to qualify under the transition provision. The investment 
would have to be more than merely the filing of an abbreviated new drug 
application [ANDA] for regulatory approval with the FDA, although the 
generic company would be able to include these costs in proving their 
investment.
  At the same time, this compromise provides unique protection to 
generic drug companies from the cost of potential delays from the court 
process prior to entering the market. If a generic drug company wins 
the determination of substantial investment, the court could order the 
patent holder to compensate the generic company for the delay in 
selling their product caused by litigation.
  What's more, Senators have heard from dozens of patient and physician 
groups who point out that without the strong patent protections 
provided by the law, the investments that have yielded critical, life-
saving drugs and biomedical products would not have been made. And 
unless that patent protection is preserved, pharmaceutical companies 
will have no incentive to continue their vital research.
  Indeed, Daniel Perry, executive director of the Alliance for Aging 
Research wrote that . . .

       Patent rights are the cornerstone of America's biomedical 
     research enterprise. Patents provide a critical incentive for 
     all companies, particularly pioneer pharmaceutical 
     manufacturers, to conduct ground breaking biomedical 
     research.

  I would ask unanimous consent that Mr. Perry's and other letters be 
printed in the Record following my remarks.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  (See exhibit 1)
  Mr. DODD. Mr. President, this is a fair and balanced compromise. The 
committee took into account the unique benefits generic drug 
manufacturers receive under the FDA process. Generic drug manufacturers 
are given the use of the safety and efficacy data that is developed 
over years of research and at an average cost of $500 million by the 
brand name pharmaceutical manufacturer. The generic drug industry, in 
contrast, spends an average of less than $1 million on their products.
  The cornerstone of our intellectual property system is that one 
person or company should not be able to profit unfairly from another's 
investment, be it in time or money, at the expense of the original 
person or company. This compromise protects that fundamental right, and 
I urge my colleagues to support it.

                               Exhibit 1

                                                     May 20, 1996.
     Hon. Orrin Hatch,
     Chairman, Committee on the Judiciary,
     U.S. Senate, Washington, DC.
       Dear Senator Hatch: We are concerned that the Senate may 
     soon consider legislation that would diminish the strong 
     patent terms for pharmaceuticals that resulted when Congress 
     implemented the General Agreement on Tariffs and Trade 
     (GATT). We thank you for your leadership and efforts to 
     preserve strong intellectual property protection. It is vital 
     that all Members of Congress share your understanding of the 
     importance to our patients of strong intellectual property 
     protection, and we ask that you share our concerns with your 
     colleagues.
       As gastroenterologists, we have seen first hand the 
     tremendous power of pharmaceutical innovation to forge 
     unparalleled advances in medical care. Prior to the discovery 
     and development of the acid-reducing medicines called H2 
     antagonists, many patients suffering from peptic ulcer 
     disease had to endure expensive corrective surgery. Since 
     1977, when the first H2 antagonist was introduced, the 
     incidence of ulcer surgery as well as ulcer-related morbidity 
     has dropped dramatically. This decline in surgery and 
     morbidity has not only benefited our patients, but it has 
     also reduced the overall health care costs for our country 
     since drug therapy is substantially less expensive--not to 
     mention less painful--than ulcer surgery.
       The argument in support of changing the GATT patent benefit 
     for pharmaceuticals seems to rest primarily on the potential 
     cost savings to consumers of accelerating the availability of 
     a generic version of one anti-ulcer drug. Such an argument 
     totally ignores the fact that the anti-ulcer marketplace is 
     highly competitive with a wide range of choices, including 
     generics, for patients and physicians.
       This argument also ignores the significant cost savings to 
     consumers from advances in medical research. There are new 
     medicines available and coming to the market that can cure 
     peptic ulcer disease. The senior citizen on a fixed income 
     will save far more from the availability of medicines that 
     eradicate the cause of his/her ulcer after a few weeks of 
     therapy than from a less expensive version of a medicine they 
     must continue to take on a daily basis. Fortunately for the 
     patient, the strong patent protection on existing anti-ulcer 
     products has helped fund the research that has made these new 
     medicines possible.
       We firmly believe that it is in the best interest of 
     patients to provide strong patent protection. The results of 
     innovative bio-medical research funded by patent protection 
     for existing products benefit patients directly. Any attempts 
     to determine the incentives to further research and 
     development is short sighted and leaves patients short 
     changed.
           Sincerely,
     John H. Walsh, M.D.,
       Professor of Medicine, UCLA, Los Angeles, CA.
     Jamie S. Barkin, M.D.,
       Professor of Medicine, Univ. of Miami, Miami, FL.
     Rosemarie L. Fisher, M.D.,
       Professor of Internal Medicine, Yale Univ., New Haven, CT.
     Stanley B. Benjamin, M.D.,
       Professor of Medicine, Georgetown Univ., Washington, DC.
     Malcolm Robinson, M.D.,
       Professor of Medicine, Univ. of Oklahoma, Oklahoma City, 
     OK.
     Joseph W. Griffin, M.D.,
       Professor of Medicine, Medical College of Georgia, Augusta, 
     GA.
     David L. Earnest, M.D.,
       Professor of Medicine, Univ. of Arizona, Tucson, AZ.
     David E. Fleischer, M.D.,
       Professor of Medicine, Georgetown Univ., Washington, DC.
                                                                    ____

                                          American Association for


                                        Cancer Research, Inc.,

                                   New York, NY, October 18, 1995.
     Hon. Robert Dole,
     Majority Leader,
     U.S. Senate, Washington, DC.
       Dear Senator Dole: The American Association for Cancer 
     Research (AACR) respectfully requests that you vote against 
     Senator Pryor's effort to reduce patent protection for 
     pharmaceuticals.
       The medical researchers in the AACR have devoted their 
     lives to research and innovation in the struggle to eradicate 
     cancer. In this effort, innovative pharmaceuticals and 
     biotechnology products are our most effective tools. Congress 
     steadfast support of scientific discovery and strong patent 
     protection has encouraged the investment in research and 
     development that make these medicines possible. For the sake 
     of patients everywhere, patent protection should not be 
     weakened.
       However, Senator Pryor's legislation to reverse the patent 
     protection extended under GATT to one industry asks you to do 
     just that. This bill attempts to grant exceptions to the GATT 
     patent protections; these exceptions if adopted, have the 
     potential to encourage future attempts to further erode 
     patent protections in the United States. We are gravely 
     concerned about the precedent of singling out one industry, 
     especially one that has positioned the United States as the 
     global leader.
       The risk of supporting this legislation would be to weaken 
     the incentives for innovation in academia, research 
     institutions, and medical research-based companies. We 
     believe that this will impede our capacity to address the 
     growing epidemic of cancer.

[[Page S6597]]

       We urge you to use your leadership position to preserve, 
     not destroy, our national capacity to support research and 
     innovation.
           Respectfully,
                                          Joseph R. Bertino, M.D.,
     President.
                                                                    ____



                                   Alliance for Aging Research

                                 Washington, DC, October 11, 1995.
     Hon. Robert Dole,
     Office of the Majority Leader, U.S. Senate, the Capitol 
         Building, Washington, DC.
       Dear Senator Dole: It has come to my attention that, in 
     connection with a proposal sponsored by Senator David Pryor, 
     Congress is considering changes to existing patent law that 
     would erode patent protection in the United States. I ask you 
     to oppose that effort.
       America has always sought to protect and foster innovation 
     primarily through our system of patent protection and patent-
     term restoration. Recently, in accordance with its 
     multilateral obligations under the Agreement on Trade-Related 
     Aspects of Intellectual Property Rights negotiated during the 
     Uruguay Round of GATT, Congress amended the Patent Code to 
     harmonize its provisions with international standards. As a 
     result, patent terms for certain eligible products--in all 
     industries--were extended. Under the Pryor proposal, however, 
     Congress would weaken our implementation of GATT's patent 
     provisions.
       As the Executive Director of the Alliance for Aging 
     Research, I am concerned by any proposal that would have such 
     an effect. Patent rights are the cornerstone of America's 
     biomedical research enterprise. Patents provide a critical 
     incentive for all companies, particularly pioneer 
     pharmaceutical manufacturers, to conduct ground breaking 
     biomedical research. Patients and their physicians depend 
     upon access to the fruits of biomedical research--access 
     which can only occur if there are adequate incentives for the 
     research to be conducted in the first place. Congress cannot 
     expect the private sector to continue making high-risk 
     investments in research and development if there is no 
     assurance of strong patent protection (and if there is no 
     assurance that the United States will meet its multilateral 
     obligations to provide such protection.)
       This is a particularly critical issue for the aging 
     Americans represented by the Alliance. Clearly, the 
     curtailment of biomedical R&D will lead to a downturn in a 
     rate at which biomedical innovations will become available to 
     the public. New incentives for research and innovation such 
     as those provided by GATT must be maintained. Otherwise, 
     Congress will erode the foundations of a system that has made 
     America the leader in the discovery of new medicines.
       I urge you to cast your vote in favor of innovation and 
     research for new treatments that will benefit America's 
     elderly.
           Best regards,
                                                     Daniel Perry,
     Executive Director.
                                                                    ____

                                      The National Organization on


                                       Fatal Alcohol Syndrome,

                                 Washington, DC, October 10, 1995.
     Hon. Bob Dole,
     Hart Senate Office Building,
     Washington, DC.
       Dear Senator Dole: It has come to my attention that, 
     through an effort by Senator Pryor, Congress is considering 
     changes to existing law that would chip away at patent 
     protections in the United States, and possibly around the 
     world. I ask you to reject that effort.
       This nation has sought to protect and foster innovation 
     since its very beginnings, primarily through our system of 
     patent protections. Most recently, as a result of the General 
     Agreements on Tariffs and Trade, the U.S. changed its patent 
     terms to bring them in line with international standards. Yet 
     Congress is now considering weakening that agreement.
       As a member of the National Organization on Fetal Alcohol 
     Syndrome, I find that possibility very disturbing. Patients 
     afflicted with disease look to biomedical research, 
     especially research taking place in America's pharmaceutical 
     industry, for new and better treatments to restore them to 
     health. But this country's huge investments in research and 
     development cannot be maintained without the assurance of 
     strong patent protection, not only in the U.S., but also in 
     other markets around the world.
       If Congress begins chipping away at patent protection in 
     the U.S., it begins chipping away at the foundations of a 
     system that has made this country Number One in the world in 
     the discovery of new medicines. It also begins to undermine 
     patent protection standards around the world. And it begins 
     the process of deflating the hopes of millions of patients in 
     this country who depend on medical research to find a cure.
       Please, cast your vote in favor of innovation, and against 
     any effort to undermine patent protection in this or any 
     other country around the world.
       Sincerely,
                                                     Patti Munter,
     President.
                                                                    ____

                                      United Patients' Association


                             for Pulmonary Hypertension, Inc.,

                                                     Speedway, IN.
     Hon. Carol Moseley-Braun,
     Hart Senate Office Building,
     U.S. Senate, Washington, DC.
       Dear Senator Moseley-Braun: I'm writing to you on behalf of 
     400-500 Americans who suffer from a very rare and very deadly 
     disease known as Primary Pulmonary Hypertension (PPH). Until 
     recently, the best hope for long-term survival from PPH was 
     through a lung or heart/lung transplant. However, today, 
     thanks to research which dates back to the 1970's, a new drug 
     was recently approved to treat PPH which not only is 
     extending these patients' lives but is allowing them to live 
     full, active and productive lives.
       I have learned that some generic companies are now trying 
     to change the law so that they can gain financially by 
     bringing their products to market before the patents on the 
     pioneering companies' products expire. I can attest to the 
     value that research-based companies bring to patients as a 
     result of strong patent protection, and I urge you to oppose 
     these efforts.
       While I appreciate the cost savings that generic drugs can 
     offer in the short term, I also know that innovative new 
     therapies for complex, life-threatening diseases will come 
     only from research-based pharmaceutical companies. When it 
     comes to serving patients suffering from deadly orphan 
     diseases like PPH, it is the research-based companies that 
     give us hope.
       Glaxo Wellcome recently received approval to market the 
     first medicine that will significantly extend the life, 
     greatly improve the quality of life, and help avoid complex, 
     risky surgery for people suffering from PPH. I know of no 
     generic drug company that would commit the millions of 
     dollars or many, many years of research to discover or 
     develop such a medicine, and it is unlikely that they will 
     ever produce a generic version for a patient population so 
     small. There are many other similar patient populations who 
     depend on the research-based companies to bring these new 
     medicines to market.
       The purpose of the General Agreement on Tariffs and Trade 
     (GATT) was to strengthen intellectual property law around the 
     world and bring U.S. intellectual property law into 
     compliance with other industrialized countries. If the GATT 
     resulted in longer patent protection for a few medicines--all 
     of which already face competition from other therapies--that 
     in my view is a benefit for our society.
       Our patients have experienced the direct benefits of the 
     tremendous investments that the pharmaceutical industry has 
     made in research and development. Research-based companies 
     need and deserve the incentives provided by strong 
     intellectual property protection. Please do nothing to weaken 
     them.
           Sincerely,
                                     Judith Simpson, R.N., Ed. S.,
     President, UPAPH.
                                                                    ____

                                               American Society of


                                Tropical Medicine and Hygiene,

                                                 October 13, 1995.
     Hon. Robert Dole,
     U.S. Senate, Hart Senate Office Building, Washington, DC.
       Dear Senator Dole: The American Society for Tropical 
     Medicine and Hygiene (ASTMH) respectfully asks that you vote 
     against Senator Pryor's effort to reduce patent protection 
     for pharmaceuticals.
       The ASTMH members have dedicated their lives to easing the 
     suffering of patients under their care and returning them to 
     health whenever possible. In this effort, modern medicines 
     are among our most effective tools. Congress' steadfast 
     support of strong patent protection has encouraged the 
     investments in research and development that make these 
     medicines possible. For the sake of patients everywhere, 
     those protections should not be weakened.
       Yet, legislation which Senators Pryor and Chafee intend to 
     bring to the Senate floor asks you to do just that. They 
     believe that Congress should grant exceptions to the patent 
     protection provided under the General Agreement for Tariffs 
     and Trade, which could encourage future attempts to further 
     erode those protections in the U.S. It would surely encourage 
     other countries to do the same, especially those who are not 
     fully committed to implementing the patent protections 
     required under GATT.
       Long-term, we risk weakening the incentives for innovation 
     that bring us new medicines from the labs of academia, 
     research organizations, and pharmaceutical research 
     companies. We risk losing more lives to disease that might 
     otherwise be saved.
       We are dedicated to improving the care we provide our 
     patients. Further, our society is dedicated to the research, 
     treatment and eradication of infectious and emerging diseases 
     worldwide. We need to ensure the U.S. capacity to operate in 
     the international arena. We ask that you lend your support by 
     preserving the innovation that helps us to meet that goal. 
     Please demonstrate your support for patent protection and 
     medical innovation by voting against Senator Pryor's 
     amendment.
           Sincerely,
                                            Carole A. Long, Ph.D.,
     President, ASTMH.
                                                                    ____



                                   Cystic Fibrosis Foundation,

                                                 October 10, 1995.
     Hon. Robert Dole,
     Majority Leader,
     U.S. Senate, Washington, DC.
       Dear Senator Dole: I understand Senators Pryor and Chafee 
     are attempting to amend the Hatch-Waxman Act to eliminate 
     extensions for existing pharmaceutical patents granted by 
     GATT. I urge you not to vote for that amendment, but instead 
     to protect existing legislation that preserves incentives for 
     research and development.

[[Page S6598]]

       As President and Chief Executive Officer of the Cystic 
     Fibrosis Foundation, I have personally witnessed the great 
     suffering endured by patients and their families in their 
     fight against cystic fibrosis. I have also witnessed how, for 
     many patients, modern medicines have brought hope, relief 
     from suffering, and even a return to health--a miracle made 
     possible by biomedical research.
       By rewarding ingenuity and encouraging innovation, patent 
     protection makes possible the investment of hundreds of 
     millions of dollars and years of time and effort in medical 
     research, all the while with no guarantee of success. Because 
     of the discoveries born of these investments, the patients we 
     come in contact with every day benefit through saved lives 
     and improved quality of life. Our health care system benefits 
     from a reduction in the overall cost of care.
       While we certainly support patient access to lower cost 
     treatments for disease, that short-term benefit pales if it 
     comes at the long-term expense of finding cures to life-
     threatening illnesses. The current law governing 
     pharmaceutical patents is fair and in the long-term best 
     interest of patients.
       On behalf of those patients who still await a cure or 
     effective treatment to alleviate their suffering, I again 
     urge you not to undercut the patent protection that underlies 
     America's best hope for new and better answers to disease.
           Sincerely,
                                           Robert J. Beall, Ph.D.,
     President and Chief Executive Officer.
                                                                    ____

                                       Allergy and Asthma Network,


                                  Mothers of Asthmatics, Inc.,

                                    Fairfax, VA, October 12, 1995.
     Senator Bob Dole,
     Majority Leader.
       Dear Senator Dole: At a time when health care delivery, 
     research and development are evolving faster than anyone can 
     accurately monitor, Senator Pryor's efforts to lead Congress 
     down a road that chips away at patent protections for U.S. 
     pharmaceutical products will dig a health care grave for 
     Americans.
       As the founder of the Allergy and Asthma Network/Mothers of 
     Asthmatics, Inc., a mother of four children, three of whom 
     have asthma, a person who has asthma, and as a member of 
     several NIH and FDA advisory councils. I understand the 
     importance, the bottom line impact, of the hastily 
     constructed and poorly debated proposed changes.
       I would be delighted to discuss the magnitude of this issue 
     with you in person or over the phone at your convenience 
     (703-385-4403), however, please vote in favor of a healthier 
     America and against any Pryor and/or Chafee proposals to 
     dilute research and development expenditures. Vote for 
     innovation and oppose any effort to undermine patent 
     protection in this country or any other country.
           Sincerely,
                                                     Nancy Sander,
     President.
                                                                    ____



                                    Autism Society of America,

                                   Bethesda, MD, October 12, 1995.
     Senator Bob Dole,
     U.S. Senate,
     Washington, DC.
       Dear Senator Dole: I understand Senators Pryor and Chafee 
     are attempting to amend the Hatch-Waxman Act to eliminate 
     extensions for existing pharmaceutical patents granted by 
     GATT. I urge you not to vote for that amendment, but instead 
     to protect existing legislation that preserves incentives for 
     research and development.
       While we certainly support patient access to lower cost 
     treatments for disease and disability rehabilitation, that 
     short-term benefit pales if it comes at the long-term expense 
     of finding cures to life-threatening illnesses. The current 
     law governing pharmaceutical patents is fair and in the long-
     term best interests of patients.
       Our organization, representing over 18,000 parents and 
     professionals whose daily lives are touched by autism, has 
     witnessed the great suffering endured by patients and their 
     families in their struggle with autism. I have personally 
     witnessed how, for many children and adults with autism, 
     modern medicines have brought relief from the extreme, often 
     life-threatening behavioral manifestations of autism, 
     resulting in a renewed hope to the families for a better 
     quality of life for their son or daughter. In some instances, 
     the change was dramatic enough that the entire individual's 
     life, and the lives of those family members who love them, 
     have reached a new level of hope and enthusiasm--a 
     ``miracle'' made possible by biomedical research.
       By rewarding ingenuity and encouraging innovation, patent 
     protection makes possible the investment of hundreds of 
     millions of dollars and years of time and effort in medical 
     research * * * all the while with no guarantee of success. 
     Because of the discoveries born of these investments, the 
     patients we come in contact with every day benefit through 
     saved lives and improved quality of life. Furthermore, our 
     health care system benefits from a reduction in the overall 
     cost of care.
       The Pryor and Chafee amendment offers a clear choice: a 
     ``NO'' vote to preserve incentives for innovation that allow 
     that research to continue, or a ``YES'' vote to undermine the 
     hope of thousands of patients who await the discovery of an 
     effective treatment for disease.
       On behalf of those patients everywhere (including some 
     380,000 individuals with autism) who still await a cure or 
     effective treatment to alleviate their suffering, I again 
     urge you not to undercut the patent protection that underlies 
     America's best hope for new and better answers to disease and 
     life-threatening disabilities.
           Sincerely,
                                               Sandra H. Kownacki,
     President.
                                                                    ____



                                  National Kidney Association,

                                                November 22, 1995.
     Hon. Carol Moseley-Braun,
     Senate Hart Office Building,
     Washington, DC.
       Dear Senator Moseley-Braun: I am writing you as both a 
     constituent, and as the President of the National Kidney 
     Cancer Association. Thank you for your recent vote in support 
     of the enforcement of the General Agreement on Tariffs and 
     Trade (GATT) provision regarding drug patents.
       Your action will allow significant pharmaceutical research 
     to continue on numerous diseases, including kidney cancer. As 
     you may be aware, kidney cancer afflicts thousand of 
     individuals each year and at the present time, no cure exists 
     for this disease.
       Our greatest hope for a cure is innovative pharmaceutical 
     and biotechnology products, derived from private sector 
     efforts. To find this cure, millions of dollars will have to 
     be spent. It is imperative that Congress provide steadfast 
     support for scientific discovery and strong patent protection 
     for new drugs and therapies. My view is that this new GATT 
     law will encourage further investment in research and 
     development, and make new medicines possible. This new law 
     gives hope to millions around the world, including kidney 
     cancer patients, who currently have no options.
       I applaud your courage in opposing efforts to weaken the 
     GATT patent provisions. Keep up the important battle to 
     support research and development of new drugs. Thank you for 
     your determination and insightful leadership.
           Sincerely,
                                              Eugene P. Schonfeld,
                                                President and CEO.

  Mr. THURMOND. Mr. President, the Pryor amendment concerns the complex 
interrelationship among the GATT Treaty, the Federal Food, Drug and 
Cosmetic Act, and the Patent Code.
  We considered this very issue last December on the Senate floor when 
Senator Pryor attempted to have this matter attached to the bill to ban 
partial birth abortions. The Senate voted at that time to have the 
Judiciary Committee--that is the committee with proper jurisdiction--to 
consider this important issue. The Judiciary Committee held a 
comprehensive hearing on this matter on February 27 of this year and 
Senator Pryor testified at that time.
  Mr. President, following the hearing in the Judiciary Committee, of 
which I am a member, the committee amended a proposal similar to 
Senator Pryor's amendment with a bipartisan compromise. The Judiciary 
Committee approved the compromise. This bill will be available for 
Senate floor consideration in due course. It would be most appropriate 
to consider Senator Pryor's amendment at that time. The Department of 
Defense reauthorization bill is not--and I want to repeat, is not--the 
proper vehicle on which to debate the Pryor amendment. Unfortunately, 
we are now having to debate this contentious intellectual property 
issue.
  Our second-degree amendment would reflect a bipartisan compromise 
agreed upon by the Judiciary Committee. The chairman of the Judiciary 
Committee, Senator Hatch, has spoken today on the practical effect of 
this amendment which he drafted with others when this matter was before 
his committee.
  Mr. President, as I noted earlier, this is a very difficult and 
complex issue which addresses how certain transition rules contained in 
the Uruguay Round Agreements Act apply to the pioneer pharmaceutical 
patents which have been extended by the act. The overall approach to 
this issue is to find an appropriate balance to encourage research and 
development of breakthrough innovator drugs while making low cost 
generic equivalents available to the public. The Judiciary Committee 
approved one approach which many believe reaches the goal of 
encouraging research and development but also expediting their generic 
equivalents to the marketplace.
  It would be my preference to debate the Pryor amendment when the full 
Senate turns to consideration of the bill recently approved by the 
Judiciary Committee. That would seem to me to be the appropriate time 
to consider the Pryor amendment. Yet, here we are on the Defense bill 
debating the Pryor amendment in a compressed manner.

[[Page S6599]]

  We should proceed on this Defense bill, which is vital to our 
national security.
  Several Senators addressed the Chair.
  The PRESIDING OFFICER. The Senator from Colorado.
  Mr. BROWN. Mr. President, I know the Senator from Nevada was here 
ahead of me. If it is all right with him, I will just make a very brief 
statement.
  Mr. BRYAN. By way of response, I am always delighted to hear the 
enlightened words of my friend from Colorado, and I anxiously await his 
important comments to the Senate.
  Mr. BROWN. I can only wish my wife held me in similarly high esteem. 
She sometimes finds my talks somewhat too long.
  Mr. President, I simply want to add a few words as cosponsor of the 
Pryor amendment. We have traded it back and forth. I think the 
distinguished Senator from Arkansas has made a great contribution by 
bringing this portion of our law up.
  It is a complicated area. I would like, with the indulgence of 
Members, just to briefly try and simplify it, if I can.
  We have in the past followed the law. The American law was 17 years 
of exclusive protection for a patented item. Many countries in the 
world had a law that said 20 years from the time of filing for that 
patent. So we differed from the world somewhat. When the trade pact was 
approved, which this Congress did approve, did ratify, we agreed to go 
to a system followed by most other countries; that is, 20 years from 
when you file it instead of 17 years from when it is approved. A modest 
change.
  For some items that are patented, that is, the creator has exclusive 
protection, that meant they got a longer period of coverage than 
originally planned, a longer period of coverage than they had when they 
created the product or invented it, a longer period of coverage than 
what they budgeted for, a longer period of coverage than what the law 
said. In other words, when we ratified that treaty and passed the 
implementing language, we made a retroactive change in the law. Twenty 
years ago, if you said, ``What is the law, what protection do I get?'' 
we changed the law even though you relied on it.

  What the GATT Treaty did and we did as a Congress was create an 
exception that said, look, if you relied on the old law and you 
invested money in reliance on that law, you should be allowed to 
compete with that product. So we did give people a serendipitous 
extension of the patent protection. But we said if someone is harmed by 
that--that is, they made a substantial investment in competing with you 
under the terms of the law--we are going to say OK for them, they have 
a right to compete.
  That is all this issue is really about. The issue is whether or not 
if you as a businessman or businesswoman made an investment in reliance 
on our law to compete, whether or not you should have a chance to 
compete.
  The way this Congress handled that issue is they drafted a transition 
rule that said, ``Yes, if you made a substantial investment, you relied 
on that law, you can compete.'' There was only one product they left 
out, and that was patented drugs. Every other patented item that this 
Nation recognizes and gives exclusive protection to got the treatment, 
got the exception, were allowed to compete if they made a substantial 
investment. The only one that did not get it was drugs.
  Is there a reason to treat drugs differently? I do not think so. That 
case certainly has not been made in deliberations. The patent 
protection is not different in length for drugs than it is for anything 
else in the past. That transition law treated drugs totally different 
than anything else.
  When we inquired about it, all the committees said, ``It's an 
oversight, it's a mistake, we'll correct it.'' That is all this 
amendment is. It simply treats drugs the same way we treat everybody 
else.
  How do I feel about it? My sense is that we ought to treat drugs like 
any other patented item. My sense is, it is only fair if someone has 
relied on that old law--that is, made an investment, relied on the 
law--that you honor your obligation. It is the same as giving somebody 
your word. It is pretty basic. It is pretty simple.
  If I say something, and you rely on it, and you invest in reliance on 
it, I ought to keep my word to you. That is what we did for every other 
patented item. That is all this amendment does.
  Do people who have patented drugs who get a serendipitous 20 
additional months, or in that range, oppose the amendment? Of course 
they do. It is not a surprise. If somebody said, ``Here's a check for 
$100 million''--the money involved in this is big; it is not small; and 
it may well be in the billions, not millions --of course they are 
interested in protecting that. I do not fault them. They are defending 
their rights.
  But, Mr. President, our obligation goes much farther than simply 
helping out a friend or helping out a company that got a serendipitous 
gift out of this. Our obligation, as Members of the U.S. Senate and 
Members of Congress, goes to protecting the public.
  There is no question that the public benefits by this amendment--no 
question. There is no question that this is fair because it is the same 
treatment everybody else got. There is no question that people who 
relied on the old law and made an investment, in my mind, deserve to be 
treated like in every other area.
  The question is pretty basic. Do you carve out a special gift and 
exception for a few companies that benefited by this oversight? Or do 
you treat them the same as everybody else? Mr. President, this Congress 
ought to be concerned about encouraging competition, not hiding from 
it. This Congress ought to be concerned about fair treatment.
  It is quite true, as the distinguished Senator from Utah indicated, 
this was considered in Judiciary. It is quite true that the Senator 
from Utah prevailed. I was unable to persuade the committee of the 
merits of my position. It is quite true that that measure that he 
passed is coming out to the floor.
  My impression, though, is a bit different than what he described with 
regard to the condition of the report that is being put together. Our 
views on it, the views that favor this amendment, have been ready for 
some time. Certainly we feel that we have played no part in holding up 
the report. We have been ready to go all this time.
  So I appreciate the Senator from Utah raising that point. Inasmuch as 
there appears to be a misunderstanding about it, we will clear it up 
this afternoon. Mr. President, let me also extend my thanks to the 
distinguished Senator from Nevada for his kindness and indulgence. I 
yield the floor.
  Mr. BRYAN addressed the Chair.
  The PRESIDING OFFICER. The Senator from Nevada.
  Mr. BRYAN. Mr. President, I thank the Chair, and I, again, express my 
appreciation to my colleague from Colorado for an extraordinarily clear 
and lucid explanation of what must appear to the folks at home, 
listening to this debate on television, as a very arcane, technical, 
esoteric kind of an argument. Let me try to distill his thoughts a 
little further, if I may.
  What we are talking about is money, big money, hundreds of millions 
of dollars, even billions of dollars. When that kind of money is on the 
table, all kinds of special interests come forward and seek to protect 
themselves. I want to comment a little bit further on that.
  One of my colleagues raised the question as to the propriety of 
adding this amendment to a Department of Defense authorization bill. I 
think there is a compelling argument as to why we should do so. The 
Department of Defense spends each year $900 million on drugs--$900 
million. If the amendment authored by the distinguished Senator from 
Arkansas, of which the Senator from Colorado and I and others are 
cosponsors, is adopted, we save $30 million each year. So the relevancy 
of this debate is very much appropriately addressed to a DOD 
authorization bill.

  My colleague from Colorado, I think, did an extraordinary job of 
explaining the history, and I will not belabor that point other than to 
make the point, as he did, this industry, the drug industry, through 
inadvertence and omission, is given separate treatment, separate, 
distinct and special treatment, that no other industry or product in 
America receives. It is that inequity that generates the interest of 
the Senator from Arkansas and others of us to remedy and to correct 
this.
  Our amendment, which was debated sometime last year, had the 
endorsement of the U.S. Trade Representative,

[[Page S6600]]

the Patent Office, and the FDA, and would plug this loophole. Since 
last December, as these windfall profits have continued to accumulate, 
American consumers, veterans, seniors, and others across the country 
have continued to pay more than they should pay for certain 
prescription drugs.
  Mr. President, the loophole is open today. We face the same issue. 
Each and every day, American consumers are paying millions of dollars 
more than they ought to. So let me suggest, as I view my 
responsibilities as a Member of this Chamber, it is highly appropriate 
that we seek to correct this inequity and to provide the relief to 
which American consumers are entitled and to do so immediately.
  When the loophole-closing amendment came to the Senate floor last 
fall, a vote was taken, a critical vote in which, by a margin of one 
vote, 48-49 the Senate defeated the amendment that the Senator from 
Arkansas, the Senator from Colorado and others of our colleagues 
offered.
  A compromise was reached after that vote. The Judiciary Committee 
would review the GATT treaty problem and report back to the Senate with 
its recommendation. This was to be a good-faith effort to analyze the 
issue. It is fair to ask the question, What was the outcome of this 
review? Well, the Judiciary Committee did report out a substitute bill 
to our GATT amendment, albeit 5 months after our amendment was voted 
upon, 5 months in which drug companies have continued to reap windfall 
profits and 5 months that the American public have been forced to pay 
higher drug prices than they should have, that the American taxpayer 
has been required to pay more money for those essential programs 
offered by the Department of Defense, the Veterans Administration, and 
other agencies of the Federal Government which purchase prescription 
drugs on behalf of the clientele which they service.
  This substitute is called the Pharmaceutical Industry Special Equity 
Act of 1996. It has somewhat of an ironic ring to it--the 
Pharmaceutical Industry Special Equity Act of 1996. Who does it 
benefit? It benefits the drug industry in a very special way that is 
inequitable to American consumers and particularly those who are on 
fixed incomes.
  What we are really being asked to support today, in the form of the 
substitute, is a bill that codifies--in my view codifies --the very 
GATT treaty mistake that our amendment seeks to correct, a bill that 
continues the GATT treaty loophole for such drug manufacturers as 
Glaxco-Wellcome, Inc. and its ulcer/heartburn drug Zantac, the world's 
best selling drug, which costs twice as much as it should because of 
this loophole that we seek to close.

  More than 100 drugs are being protected from generic drug competition 
because of this loophole. These include the hypertension drug Capoten, 
which costs 40 percent more due to the loophole, and the cholesterol-
lowering drug Mevacor, the ulcer drug Prilosec, and the antifungal 
agent drug Diflucan.
  It is a bill that ensures that seniors across the Nation will 
continue to pay more than they should for prescription drugs that they 
need and that are essential to their health, a bill that ensures 
taxpayers will pay more than they should to provide prescription drugs 
for the Medicaid and the veterans medical programs, a bill that creates 
tremendous legal barriers--in my view, insurmountable barriers--to the 
generic drug manufacturing industry to ensure that these manufacturers 
cannot bring to the marketplace lower priced prescription drugs, a bill 
that ensures the prescription drug manufacturers continue to enjoy 
their $2.3 billion windfall, plus a bill that extends special patent 
extensions for two brand name drug companies, Zeneca and Wyeth Ayerst 
Laboratories, which received a 2-year patent extension for Lodine, its 
antiinflammatory medicine. What has occurred here? In my view, we have 
a situation that is worse than before. Not only do some prescription 
drug companies retain their windfall profits, they are protected from 
nearly any possibility that any generic manufacturer will be able to 
compete against them during this extended patent term.

  Generic drug manufacturers will be required to prove a substantial 
investment before being allowed to compete against any brand name drug. 
The key change, however, is that this substantial investment 
requirement is being defined much differently, to ensure the generic 
manufacturers cannot, as a practical matter, compete against any brand-
name drug benefiting from the extended patent period under the GATT 
Treaty.
  Before the GATT Treaty, substantial investment was considered to be 
those expenses and activities involved in developing a submission to 
compete to the FDA. Under the substitute measure, substantial 
investment is defined much differently.
  In addition, under the substitute bill, a generic manufacturer must 
prove not only they have a substantial investment, but also they are 
required to make a determination of the kind of equitable remuneration 
to the brand name manufacturer before any generic drug can be 
manufactured.
  Mr. President, you do not have to be a rocket scientist to recognize 
those who are enjoying these windfall profits are not going to be eager 
to agree as to what equitable remuneration may be. In effect, we create 
a lawyers' field day to debate what is, in fact, equitable 
remuneration.
  The effect of the change is, first, it will be virtually impossible 
for any generic manufacturer to meet the new substantial investment 
standard. Secondly, it will mean that generic manufacturers will be 
tied up in court proving substantial investment and what is equitable 
remuneration before they can bring any generic drug to the marketplace. 
Two obstacles, two hurdles, two barriers that, as a practical matter, 
are going to be virtually insurmountable.
  Who is being forgotten? Who gets hurt in this change? Those Americans 
particularly that are on a fixed income. That is primarily our senior 
community. They have been paying and will continue to pay more than 
they should for lack of a prescription drug alternative.
  I am puzzled to think as to why anyone believes it is equitable to 
force seniors, many on very limited incomes, to pay more for a drug 
than they should so prescription drug manufacturers can continue to 
reap the windfall profits that this loophole has created.
  I must say I am astonished by the provisions of this Pharmaceutical 
Industry Special Equity Act--a misnomer, if ever there was one; a 
special interest provision, if there ever was. My colleagues who talk 
the virtues of competition in the marketplace surely must find this 
substitute bill to be a bit beyond the pale.
  I remind my colleagues, there is no reason to allow a limited number 
of prescription drug companies an unintended windfall profit to the 
detriment of all Americans who depend upon prescription drugs in order 
to sustain their health. Seniors, veterans, and the most vulnerable in 
our country cannot fight the brand name pharmaceutical industry on its 
own. They deserve and need our protection from an industry that is 
trying to codify a mistake, to perpetuate their windfall profit 
markets.
  I hope my colleagues can see the loophole for the mistake it is and 
this substitute bill for the larger mistake it would be. We should 
always remember who is being hurt by the loophole in the State.
  We have the ability to end this inequity now. The means to do so is 
the amendment offered by my distinguished colleague from Arkansas. I 
yield the floor.
  The PRESIDING OFFICER. The Senator from Pennsylvania.
  Mr. SPECTER. I thank the Chair.
  Mr. President, I have found the current controversy to be an 
extremely complicated one as it has worked its way through the 
Judiciary Committee in trying to structure an arrangement which would 
be fair to all sides--fair to those who have made investments in patent 
pharmaceutical products and fair to those who are relying upon generic 
drugs.
  As has been indicated at some length, we have very substantial 
investments which were being made to find new pharmaceutical products, 
to cure many ailments--wonder drugs, so to speak. At the same time, 
there is an enormously important consideration that generic drugs be 
available to senior citizens and others who are of modest

[[Page S6601]]

means, and also to help reduce the tremendous governmental costs 
involved with health care in America.
  The controversy has arisen because of the ambiguity in the term 
substantial investment and the difficulty in defining equitable 
remuneration. It is my view that the Congress ought to define those 
terms, as opposed to leaving the matter to judicial interpretation.
  We talk a great deal on the floor of the U.S. Senate about not having 
judges involved in legislation and about having statutory definitions 
to express the will of the Congress. This, I think, is a classic case 
where the Congress really ought to come to grips with the complexities 
and define what we mean by substantial investment and what we mean by 
equitable remuneration.
  In order to try to reach a resolution of this matter, my staff and I 
have worked for many months, including long meetings where I have 
personally participated with representatives from both sides in an 
effort to try to structure a definition which would be fair and 
equitable. There has been a consideration that substantial investment 
would be determined solely by the filing by the generic of the 
abbreviated new drug application (ANDA) prior to June 8 of 1995.
  I am not persuaded that the filing of an ANDA in and of itself is 
sufficient to constitute a substantial investment. There is a 
contention that more has to be undertaken in order to constitute the 
so-called substantial investment.
  I have supported the amendment by Senator Hatch in the Judiciary 
Committee with substantial reservations, waiting until the time the 
matter reached the floor with the hope we might work out an 
accommodation among all of the parties. As I have said to the parties 
privately and also publicly, they have a much firmer handle on the 
intricacies of these definitions than do we in the Congress. I am still 
hopeful that a compromise may be worked out.
  What I have added to the so-called Hatch substitute is a very tight 
time line on judicial determination as to what is a substantial 
investment if we cannot find a legislative definition for substantial 
investment, and also a provision that any losses sustained by the 
generic companies for the lack of sales in the interim be compensated 
by the pharmaceutical companies which have the patents.
  Another consideration which I find to be very problematic is the fact 
this has taken so long. As the distinguished Senator from Arkansas has 
pointed out, the fact that it takes so long disadvantages the generics 
and also those who would rely upon the generic products.
  I just had a brief conversation with my distinguished colleague from 
Arkansas, Senator Pryor, and I told him I thought it might be useful if 
we had a colloquy on the record. We have had quite a number of 
conversations and have exchanged correspondence, and at one point 
several weeks ago Senator Pryor wrote me a very strong, friendly 
letter, but a strong letter in the sense of trying to resolve the 
issue. I responded the very next day because of the importance of the 
issue. I know the sincerity with which the Senator from Arkansas has 
dealt with the issue, as, candidly, have we all.
  I think it would be useful to discuss with the Senator from Arkansas, 
the originator of the original legislation, the content of his 
proposal, which, as I understand it, is to have a determination of 
substantial investment or the generic filing of the so-called ANDA 
prior to June 8, 1995.
  As I understand it, and I put this in the form of a question to my 
colleague from Arkansas, is it the intent of his bill that the generic, 
in order to qualify, would have to establish a substantial investment?
  Mr. PRYOR. Mr. President, if I may respond to my friend from 
Pennsylvania, we all recognize that the question of substantial 
investment in this particular issue has been of great concern to the 
Senator from Pennsylvania.
  It is true that we have corresponded about this issue. I have 
attempted to accommodate the Senator's concern in our legislation for a 
more precise definition of substantial investment. In fact, our 
original legislation included a provision which very narrowly defined 
substantial investment. While we, too, sought to provide guidance to 
the courts, the provision was regrettably attacked by Glaxo and its 
compatriots as an effort to provide special treatment to their generic 
competitors. To ensure that all parties understood that our amendment 
is a simple, straightforward effort to bring a rogue industry into 
compliance with the rest of the country, we withdrew this language.
  Mr. President, as I understand the complex GATT implementing law, the 
generic competitor has the burden of establishing whether it has made a 
substantial investment in court. This is my understanding of the 
present law, and the present law would simply be extended in the area 
of substantial investment to the inappropriately exempted prescription 
drug industry if my proposal is adopted.
  Mr. SPECTER. Mr. President, if I may follow up on that, I do not 
fully understand what the Senator from Arkansas just said. Would it be 
the obligation, then, of the generic manufacturer to show that there 
had been compliance with the law, that there had been a substantial 
investment?
  Mr. PRYOR. That is absolutely true. The Uruguay Round Agreements Act 
clearly establishes it is the obligation of the generic competitor to 
prove a substantial investment before the court. It is the court which 
determines whether or not a substantial investment has, in fact, been 
made. This is true for all industries today, except for one.
  Mr. SPECTER. Well, since that is the purported intent of the 
legislation of the Senator from Arkansas, then the sale of the generic 
could not be made until the court had determined that there was a 
substantial investment. It is my understanding that the substitute 
proposed by the distinguished Senator from South Carolina, Senator 
Thurmond, in collaboration with the distinguished Senator from Utah, 
Senator Hatch, would do the same thing. The substitute would not accept 
the filing, but would require the generic manufacturer to go to court 
and satisfy the court that there had been a substantial investment. Is 
that not the effect of the legislation of the Senator from Utah?
  Mr. PRYOR. Mr. President, I regret I must correct the Senator from 
Pennsylvania. Both current law and our amendment allows for the sale of 
generic competitors, contemporaneous to a court determination of 
substantial investment. In other words, the term substantial investment 
is defined in the Pryor-Brown-Chafee-Bryan legislation in the present 
language of the GATT implementing legislation, the Uruguay Round 
Agreements Act. I thank my colleague for raising a very important 
point. We are not changing the GATT agreement on substantial investment 
in any shape, form, or fashion. In fact, by bringing this sole outlier 
industry into compliance with the rest of the country, one might argue 
that we are keeping even closer to the spirit and letter of our 
obligations under that agreement than is the case today.
  Mr. SPECTER. Well, if the Senator from Arkansas is prepared to have a 
judicial determination as to what a substantial investment is before 
the generic is offered for sale --I see my colleague shaking his head 
in the negative. I thought that is what the Senator from Arkansas said.
  Mr. PRYOR. No, my friend and colleague is mistaken. The present law 
says that a generic competitor may come onto the marketplace, even 
though the court has not resolved the issue of whether they have made 
substantial investment. If, hypothetically, after the generic 
competitor has entered the marketplace and competed with the patent 
holder, it is then determined by the court that a substantial 
investment has not been made, then the court imposes damages upon the 
generic competitor to render the patent holder whole.
  Mr. SPECTER. Well, how is that fee or compensation determined?
  Mr. PRYOR. That compensation is determined according to the language 
of the Uruguay Round Agreements Act, the GATT implementing legislation. 
On that point, let me reference the letter from the Department of 
Health and Human Services about the Thurmond-Hatch substitute. This is 
the agency which would have to implement the substitute. The letter 
states that ``it will be nearly impossible to meet the

[[Page S6602]]

`substantial investment' requirement'' under the substitute. Elsewhere, 
it concludes the substitute ``defines substantial investment--a matter 
that the URAA left to the courts--and does so in a manner that would 
make it virtually impossible for a generic drug company to meet the 
requirement.''
  Mr. SPECTER. If the Senator from Arkansas would come back to my 
question, I am not on the Thurmond-Hatch substitute. My question is on 
the proposal of the Senator from Arkansas; that is, if you allow the 
generic to enter the field without a determination by a court of what 
is a substantial investment, and then, as the Senator from Arkansas 
said, if there is a later determination that there has not been a 
substantial investment and the generic company has to pay compensation, 
how is that compensation determined?
  Mr. PRYOR. If I might respond to my colleague, in 35 U.S.C. 284, the 
situation is this. If, in the extremely unlikely event that a false 
claim of substantial investment is actually made by a generic 
competitor coming into the marketplace, the court may award damages in 
full, plus interest. If for some reason the court felt particularly 
strongly that the claim of substantial investment was false, fraudulent 
or otherwise inappropriate, it has further discretion to award treble 
damages to the patent holder.
  Mr. SPECTER. If my colleague will yield, I am not talking about 
fraud, I am talking simply about a conclusion that there has not been a 
substantial investment, and then you have a situation where the generic 
has been selling its product. How is there a determination made as to 
what the damages are to the pharmaceutical company that has the patent?
  Mr. PRYOR. I would answer my colleague with reference to the law as 
it currently affects every industry but one. The court would determine 
damages on the basis of lost sales or profits, the length of time 
expired, and the multitude of other facts which leave the court 
uniquely suited to make such determinations on a case-by-case basis. I 
believe that was the compelling logic behind adoption of the GATT 
language in this respect, and I feel it should be equally compelling 
for this single, rogue industry.
  I would again emphasize that we are not changing the GATT or URAA 
language as it relates to substantial investment. We are keeping it. We 
are applying this language to the drug companies, just as it applies to 
every other company, every other industry, and every other business 
entity in our country.
  Mr. SPECTER. Well, as the Senator from Arkansas outlines, there is 
going to be a judicial determination, and the question is whether the 
generic drugs may be sold prior to the time the judicial determination 
is made, or whether the generic drugs may be sold only after the 
judicial determination is made.
  Under the expedited procedures that I am proposing, it would be a 
very, very prompt resolution. If the court determines that the generic 
had a substantial investment and had been denied access to the market 
for a period of time, then, for the period of time where the generic 
had been denied access, there would be damages paid. Really, we are 
very close together, as the Senator and I discussed this, with the 
essential difference being, who is going to bear the burden of proof in 
showing substantial investment? Those facts, really, are within the 
control of the generic manufacturer--after all, it is the generic 
manufacturer who knows what the generic manufacturer has sold, and it 
seems to me that there ought to be that determination made.
  As I listened to the Senator from Nevada earlier, I understood him to 
say that there would be a determination of substantial investment prior 
to the entry into the market of the generic manufacturer. As I had 
listened to the Senator from Arkansas earlier, it seemed to me that 
that was the same contention, that there would be a determination of 
substantial investment prior to the entry by the generic manufacturer.
  Mr. PRYOR. As I mentioned earlier, we are not in any way changing the 
URAA or GATT language. In fact, I look forward to the Senator from 
Pennsylvania offering language or an amendment to expedite the 
convoluted process contemplated in the substitute version. I emphasize 
again the reservations of the Department of Health and Human Services, 
regarding both the interminable delays in litigation and the unique, 
unattainable requirements imposed on generic competitors through the 
substitute version's unworkable definition of substantial investment. 
And as Professor Levin--I might say, probably known well by the Senator 
from Pennsylvania--of the University of Pennsylvania has concluded----
  Mr. SPECTER. He is a good friend. He is not always necessarily right.
  Mr. PRYOR. Professor Levin concluded that the sense-of-the-Senate 
language in the Hatch substitute purporting to encourage parties to 
litigate quickly was of little effect. I quote:

       This is laudable sentiment but without legal impact. In 
     short, it evidences recognition of the problem but not an 
     effective solution.

  That is from Professor Levin.
  So my colleagues and I look forward to the Senator's contribution to 
this issue. We have already addressed this question with him before. I 
can say without reservation that any changes proposed in the Senate to 
expedite litigation under the Hatch-Thurmond substitute would be 
welcome, as it currently contemplates an entirely unworkable and 
unbalanced process intended to block competition in the marketplace.
  So I look forward to the Senator from Pennsylvania offering that 
contribution. I look forward to working with him. I agree that we are 
very close to a meeting of the minds on this particular issue.
  Mr. SPECTER. Mr. President, I do intend to pursue the expedited 
procedure. One of the items that I agree with the Senator from Arkansas 
on is how much time has passed here. I think that his cause might be 
advanced by accepting the burden of proof on the generic manufacturer 
and allowing this litigation to go forward with the provision for 
expedited procedures, and then damages for any time that the generic 
manufacturers are denied entry into the market after a substantial 
investment had been made, as determined in judicial proceedings, 
because what is happening now is that there have been lengthy 
proceedings in the Judiciary Committee. We have a very busy calendar.
  The managers of this bill want to move ahead with the Department of 
Defense authorization bill. But having brought this matter to the 
floor, it is an important one which merits at least this much 
discussion. We think that the Members could come to an agreement and 
find some way to expedite a legislative determination, which even if 
the burden is shifted to the generics--and they have to establish the 
judicial determination first--it may be very much more to the Senator's 
advantage than having this matter go over from today to sometime in the 
future. And who knows when there will be a determination, given the 
short year, the election year, the appropriations bills, and all of the 
work of the Congress will have?
  Mr. PRYOR. Mr. President, let me respond. Then I am going to sit down 
because I am going to Little Rock in just a few minutes.
  Mr. SPECTER. Mr. President, maybe I should save my better arguments 
for later.
  Mr. PRYOR. This Senator looks forward to working with him on this 
matter. We also would like to respond by saying that we hope when the 
Senator offers an amendment or language in this field, that it will not 
be a lawyers relief amendment, which the substitute amendment very 
clearly is in fact and in effect. It would tie up the marketplace in 
litigation with impossible definitions and insuperable barriers for 
years and years.
  Speaking of expedited procedure, I have been trying since January to 
get on the floor and have a vote on this amendment--just a simple vote 
with an hour or 30 minutes equally divided, whether up or down or to 
table the amendment. But for some reason or another, some of my 
colleagues on the other side, including some of my very best friends, 
have prevented this all year.

  Before we move forward and before the final vote is cast on this DOD 
authorization bill, this Senator is going to get a vote on our 
amendment. We think that it should be voted on. We think that is only 
fair. And I am going to push for a vote on this proposal on the DOD 
authorization bill.

[[Page S6603]]

  The Senator from Pennsylvania probably knows that the Department of 
Defense buys $900 million worth of prescription drugs every year for 
servicemen and servicewomen all over the world. They can save $30 
million overnight by the passage of the amendment that my colleagues 
and I have proposed.
  I hope our friend and colleague, the Senator from Pennsylvania, will 
help us find an expedited procedure to bring this amendment to a 
favorable resolution by letting the Senate vote up or down on it once 
and for all.
  I thank the Senator.
  Mr. SPECTER. I thank my colleague for the colloquy. I will try to 
help him find an expedited procedure. I will not suggest anything that 
would make a lawyer rich, even though my colleague may be returning to 
the practice of law after he finishes the distinguished service in this 
Congress. But it would be my suggestion that Senator Pryor, Senator 
Hatch, Senator Thurmond, and the Members sit down and try to work it 
out, to try to get the parties in the pharmaceutical companies and the 
generics, where they really understand the intricacies and the facts of 
the matter, to try to solve this off the floor, because I think that 
would be in the best interest of the American people.
  Mr. KEMPTHORNE. Mr. President, what is the pending business before 
the Senate?
  The PRESIDING OFFICER (Mr. Abraham). The Kyl amendment No. 4049.
  Mr. KEMPTHORNE. Mr. President, I ask unanimous consent on behalf of 
Senator Brown that he be added as a cosponsor to amendment No. 4055, 
the Kerrey-McCain amendment regarding compensation for lost commandos.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. KEMPTHORNE. Mr. President, I ask unanimous consent to lay aside 
the pending amendment.
  The PRESIDING OFFICER. Without objection, it is so ordered.


                           Amendment No. 4089

(Purpose: To waive any time limitation that is applicable to awards of 
           the Distinguished Flying Cross to certain persons)

  Mr. KEMPTHORNE. I offer an amendment which would waive the time 
limitations toward certain declarations for specified persons. I 
believe the amendment has been cleared on both sides.
  The PRESIDING OFFICER. The clerk will report.
  The clerk read as follows:

       The Senator from Idaho [Mr. Kempthorne] proposes an 
     amendment numbered 4089.

  Mr. KEMPTHORNE. Mr. President, I ask unanimous consent that reading 
of the amendment be dispensed with.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment is as follows:

       At the end of subtitle D of title V add the following:

     SEC. 540. WAIVER OF TIME LIMITATIONS FOR AWARD OF CERTAIN 
                   DECORATIONS TO SPECIFIED PERSONS.

       (a) Waiver of Time Limitations.--Any limitation established 
     by law or policy for the time within which a recommendation 
     for the award of a military decoration or award must be 
     submitted shall not apply in the case of awards of 
     decorations as described in subsection (b), the award of each 
     such decoration having been determined by the Secretary of 
     the Navy to be warranted in accordance with section 1130 of 
     title 10, United States Code.
       (b) Distinguished Flying Cross.--Subsection (a) applies to 
     awards of the Distinguished Flying Cross for service during 
     World War II as follows:
       (1) First award.--First award, for completion of at least 
     20 qualifying combat missions, to the following members and 
     former members of the Armed Forces:
       Vernard V. Aiken of Wilmington, Vermont.
       Ira V. Babcock of Dothan, Georgia.
       George S. Barlow of Grafton, Virginia.
       Earl A. Bratton of Bodega Bay, California.
       Herman C. Edwards of Johns Island, South Carolina.
       James M. Fitzgerald of Anchorage, Alaska.
       Paul L. Hitchcock of Raleigh, North Carolina.
       Harold H. Hottle of Hillsboro, Ohio.
       Samuel M. Keith of Anderson, South Carolina.
       Otis Lancaster of Wyoming, Michigan.
       John B. McCabe of Biglerville, Pennsylvania.
       James P. Merriman of Midland, Texas.
       The late Michael L. Michalak, formerly of Akron, New York.
       The late Edward J. Naparkowsky, formerly of Hartford, 
     Connecticut.
       A. Jerome Pfeiffer of Racine, Wisconsin.
       Duane L. Rhodes of Earp, California.
       Frank V. Roach of Bloomfield, New Jersey.
       Arnold V. Rosekrans of Horseheads, New York.
       Joseph E. Seaman, Jr. of Bordertown, New Jersey.
       Luther E. Thomas of Panama City, Florida.
       Merton S. Ward of South Hamilton, Massachusetts.
       Simon L. Webb of Magnolia, Mississippi.
       Jerry W. Webster of Leander, Texas.
       Stanley J. Orlowski of Jackson, Michigan.
       (2) Second award.--Second award, for completion of at least 
     40 qualifying combat missions, to the following members and 
     former members of the Armed Forces:
       Ralph J. Deceuster of Dover, Ohio.
       Elbert J. Kimble of San Francisco, California.
       George W. Knauff of Monument, Colorado.
       John W. Lincoln of Rockland, Massachusetts.
       Alan D. Marker of Sonoma, California.
       Joseph J. Oliver of White Haven, Pennsylvania.
       Arthur C. Adair of Grants Pass, Oregon.
       Daniel K. Connors of Hampton, New Hampshire.
       Glen E. Danielson of Whittier, California.
       Prescott C. Jernegan of Hemet, California.
       Stephen K. Johnson of Englewood, Florida.
       Warren E. Johnson of Vista, California.
       Albert P. Emsley of Bothell, Washington.
       Robert B. Carnes of West Yarmouth, Massachusetts.
       Urbain J. Fournier of Houma, Louisiana.
       John B. Tagliapiri of St. Helena, California.
       Ray B. Stiltner of Centralia, Washington.
       (3) Third award.--Third award, for completion of at least 
     60 qualifying combat missions, to the following members and 
     former members of the Armed Forces:
       Glenn Bowers of Dillsburg, Pennsylvania.
       Arthur C. Casey of Irving, California.
       Robert J. Larsen of Gulf Breeze, Florida.
       William A. Nickerson of Portland, Oregon.
       David Mendoza of Mcallen, Texas.
       (4) Fourth award.--Fourth award, for completion of at least 
     80 qualifying combat missions, to the following members and 
     former members of the Armed Forces:
       Arvid L. Kretz of Santa Rosa, California.
       George E. McClane of Cocoa Beach, Florida.
       Robert Bair of Ontario, California.
       (5) Fifth award.--Fifth award, for completion of at least 
     100 qualifying combat missions, to the following members and 
     former members of the Armed Forces:
       William A. Baldwin of San Clemente, California.
       George Bobb of Blackwood, New Jersey.
       John R. Conrad of Hot Springs, Arkansas.
       Herbert R. Hetrick of Roaring Springs, Pennsylvania.
       William L. Wells of Cordele, Georgia.
       (6) Sixth award.--Sixth award, for completion of at least 
     120 qualifying combat missions, to Richard L. Murray of 
     Dallas, Texas.


                Amendment No. 4090 to Amendment No. 4089

 (Purpose: To amend title 18, United States Code, with respect to the 
stalking of members of the Armed Forces of the United States and their 
                          immediate families)

  Mr. WARNER. Mr. President, I send to the desk an amendment in the 
second degree.
  The PRESIDING OFFICER. The clerk will report.
  The bill clerk read as follows:

       The Senator from Virginia (Mr. Warner), for himself, and 
     Mrs. Hutchison, proposes an amendment numbered 4090 to 
     amendment No. 4089.

  Mr. WARNER. Mr. President, I ask unanimous consent that reading of 
the amendment be dispensed with.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment is as follows:
       At the end of the amendment, add the following new section:

     SEC.   . MILITARY PERSONNEL STALKING PUNISHMENT AND 
                   PREVENTION ACT OF 1996.

       (a) Short Title.--This section may be cited as the 
     ``Military Personnel Stalking Punishment and Prevention Act 
     of 1996''.
       (b) In General.--Title 18, United States Code, is amended 
     by inserting after section 2261 the following:

     ``Sec. 2261A. Stalking of Members of the Armed Forces of the 
       United States

       ``(a) In General.--Whoever, within the special maritime and 
     territorial jurisdiction of the United States or in the 
     course of interstate travel, with the intent to injure or 
     harass any military person, places that military person in 
     reasonable fear of the death of, or serious bodily injury to, 
     that military person or a member of the immediate family of 
     that military person shall be punished as provided in section 
     2261.
       ``(b) Definitions.--For purposes of this section--
       ``(1) the term `immediate family' has the same meaning as 
     in section 115; and
       ``(2) the term `military person' means--
       ``(A) any member of the Armed Forces of the United States 
     (including a member of any reserve component); and
       ``(B) any member of the immediate family of a person 
     described in subparagraph (A).''.
       (c) Conforming Amendments.--
       (1) Section 2261(b) of title 18, United States Code, is 
     amended by inserting ``or section 2261A'' after ``this 
     section''.
       (2) Sections 2261(b) and 2262(b) of title 18, United States 
     Code are each amended by

[[Page S6604]]

     striking ``offender's spouse or intimate partner'' each place 
     it appears and inserting ``victim''.
       (3) The chapter heading for chapter 110A of title 18, 
     United States Code, is amended by inserting ``AND STALKING'' 
     after ``VIOLENCE''.
       (d) Clerical Amendment.--The table of sections at the 
     beginning of chapter 110A of title 18, United States Code, is 
     amended by inserting after the item relating to section 2261 
     the following new item:

``2261A. Stalking of members of the Armed Forces of the United 
              States.''.

       (e) Effective Date.--This section and the amendments made 
     by this section shall take effect on the day after the date 
     of enactment of this Act.

  Mr. WARNER. Mr. President, I ask for the yeas and nays on the 
amendment.
  The PRESIDING OFFICER. Is there a sufficient second?
  There is a sufficient second.
  The yeas and nays were ordered.
  Mr. WARNER. Mr. President, this amendment in the second degree I send 
on behalf of myself and the distinguished Senator from Texas [Mrs. 
Hutchison]. The amendment in the second degree reflects legislation 
that is badly needed by the whole of the United States. But given 
certain parliamentary situations at this time, this amendment submitted 
by myself and Senator Hutchison is limited to military personnel and 
their dependents.
  It is my judgment that the Congress has been far too slow to address 
fully the rising problems associated with the many forms of domestic 
violence. This amendment directs the Congress' attention to one form, 
commonly referred to as ``stalking.'' It will enable military personnel 
and their dependents and families to better deal with this tragic 
problem, which, regrettably, is on the rise all across our land.
  Yesterday I attended a press conference with Senator Hutchison, at 
which time she issued a plea concerning her bill, which is identical in 
many forms to this bill but applicable to all women across the United 
States--let her bill go free. It is at the desk, being held at the 
desk. Yet, all across this great Nation of ours, women every day are in 
fear for themselves, their families, and their children.
  Mr. President, it is time for the Senate of the United States to act. 
The House has acted, and it is time for the Senate to act.
  I have joined with Senator Hutchison on her bill, but we were 
informed--and I say with respect to the managers on the other side of 
the aisle--that the strongest objection would be issued if Senator 
Hutchison and I were to raise her bill as an amendment to this military 
authorization bill. Therefore, I, along with Senator Hutchison, have 
carved out from her bill companion legislation which applies to 
military personnel, their dependents and their families. That is what I 
have just sent to the desk as an amendment in the second degree.
  Military women are in some respects at greater risk than others 
because so often they are, on the shortest of notice, transferred to 
other States, other jurisdictions, in a matter of an hour or less, to 
take on new responsibilities. It is imperative that they be given the 
maximum protection against this frightful crime.
  Further, in my State of Virginia, an integral part of the greater 
Metropolitan Washington area covering Virginia, Maryland, and District 
of Columbia, it is a matter of great ease to cross the jurisdictional 
lines between the three entities. This amendment would provide the most 
important protection, Mr. President, whereby if a spouse were to obtain 
a restraining order in a court, that restraining order would be equally 
effective in other States and jurisdictions.
  I want to repeat that. One of the main features of this amendment is 
to allow that individual menaced by the threat or actuality of stalking 
to get a court order and to have that court order effective equally in 
the 49 other States and the District of Columbia.
  I bring to the attention of the Senate an article which appeared in 
the Washington Post just a few days ago dated June 16, 1996. The 
headline reads ``Navy Officer, Husband Die After Shooting at Andrews 
Air Force Base.'' This incident happened right here in Maryland. I will 
read the article in part and ask unanimous consent, Mr. President, the 
entire article be printed at the end of my presentation of the 
amendment.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  (See exhibit 1.)

       Mr. WARNER [reading]. When military police at Andrews Air 
     Force Base received a warning early yesterday that a man was 
     on his way to the military installation to kill his wife, 
     they raced to close the gates of the base. But a short time 
     later, both husband and wife, a Navy petty officer, lay dead 
     inside their home and an Air Force police officer was 
     seriously wounded. The slain woman was identified by Air 
     Force officials as Melissa Comfort, age 28. Her husband was 
     Michael Comfort, age 34. The couple's two young daughters and 
     another adult who were inside the home for several hours 
     after Michael Comfort arrived were unharmed.

  The woman had obtained, Mr. President, a court order. This amendment 
would provide protection for persons like Petty Officer Comfort and 
military personnel all over the United States, their spouses and their 
dependents. It would make it a Federal crime to stalk another person on 
a military installation. Second, stalkers subject to restraining orders 
issued in any one State or the District of Columbia would be guilty of 
a Federal crime if they followed their victim to another jurisdiction 
and violated the terms of the order. In both of these instances, this 
amendment would enlist the resources of the Federal Bureau of 
Investigation to work with local law enforcement in the investigation 
and such other actions taken by law enforcement in the prosecution of 
the stalking cases. This amendment would be especially effective for 
military personnel and their families in this greater metropolitan 
area, as I stated, because of the close proximity of the three legal 
jurisdictions.
  This extension of the enforcement mechanisms of a court order across 
State lines is the very heart of this legislation, Mr. President, 
together with enlisting the very able expertise of the Federal Bureau 
of Investigation.
  This amendment is unquestionably relevant to the issues raised by the 
annual authorization bill because it is the duty of the Armed Services 
Committee and the duty of the Senate as a whole to provide military 
personnel every possible assistance in the prosecution of their duties 
in wearing the uniform. Protection of military personnel and their 
families is a key component in maintaining a well-trained and motivated 
military force. More and more women, fortunately, are joining our Armed 
Forces. I mention that in the context of the fact that women are by far 
the primary victims of this type of domestic violence. Congress must, 
therefore, take care that our support system for which we are 
responsible--remember, Congress is the one that is responsible for the 
support system of the U.S. military--is such that they can perform 
their duties.

  Mr. President, I am a strong supporter of S. 1729, the bill that is 
currently at the desk, sponsored by the distinguished Senator from 
Texas, Mrs. Hutchison, entitled, ``Interstate Stalking, Punishment and 
Prevention Act of 1996.'' This legislation would do even more to 
significantly enhance the fabric of laws designed to deter and punish 
stalking.
  First, the measure of the Hutchison bill would make it a Federal 
crime to stalk another person across State lines or on Federal 
property. The amendment I am introducing today will address those cases 
involving the military and their dependents. Hopefully, the Congress 
will take up the Hutchison bill so that it is applicable to all women. 
The value of today's procedure is that the Senate will vote on the 
Warner amendment eventually. It will vote. I predict this vote may well 
be 100 to nothing, sending the strongest signal that this legislation, 
which will be adopted for military personnel and their dependents, 
should be expeditiously adopted for all women across this land.
  Stalkers, under both bills, covered by one State's restraining order 
would face a Federal felony--a Federal felony --if they followed their 
victims to another State or the District of Columbia and continued to 
perpetrate the criminal action of stalking.
  Third, the relationships other than spouses and ex-spouses would be 
covered by the Hutchison bill, recognizing abusive relationships can 
and do happen between persons of the opposite sex who are not married 
or divorced.
  Mr. President, this action by the Congress is long overdue. As I 
said, the House has acted on a companion piece

[[Page S6605]]

of legislation to that being held at the desk. There is no reason, in 
my judgment, why the Senate should not expeditiously act, as has the 
House of Representatives, to get this bill to the President for 
signature as quickly as possible.
  Mr. President, I yield the floor.

                               Exhibit 1

               [From the Washington Post, June 16, 1996]

  Navy Officer, Husband Die After Shootings at Andrews Air Force Base

                  (By Steve Vogel and Arthur Santana)

       When military police at Andrews Air Force Base received a 
     warning early yesterday that a man was on his way to the 
     military installation to kill his wife, they raced to close 
     the gates to the base. But a short time later, both husband 
     and wife, a Navy petty officer, lay dead inside their home, 
     and an Air Force police officer was seriously wounded.
       The slain woman was identified by Air Force officials as 
     Melissa Comfort, 28. Her husband was Michael Comfort, 34. The 
     couple's two young daughters and another adult, who were 
     inside the home for several hours after Michael Comfort 
     arrived, were unharmed, authorities said.
       Just before 2:30 a.m., someone called 911 and reported that 
     Melissa Comfort's life was in danger. Officials have not 
     identified the caller.
       After police dispatchers altered the base about the call, 
     military police sealed off Andrews to try to prevent Michael 
     Comfort from entering, according to Air Force officials. But 
     it is possible that he already may have been on the grounds. 
     Michael Comfort, who is not in the military, did not live 
     with his wife on the base, according to Lt. Karl Johnson, a 
     Navy spokesman, who said Michael Comfort was barred from 
     seeing his wife by a protective order.
       ``Unfortunately, the individual got in before they locked 
     down, or he jumped the fence,'' said Mike Beeman, a base 
     spokesman. Beeman said Air Force police took action ``moments 
     after'' the warning was received.
       Two members of Air Force Security Police were sent to check 
     on Melissa Comfort and her daughters in the town house-style 
     duplex in the 4600 block of Maple Court on the western edge 
     of the base. But upon arrival, a man fired a shotgun at the 
     officers, officials said.
       ``One guy opened fire and then retreated inside the 
     house,'' Beeman said.
       One of the military police officers, security Airman 1st 
     Class Michael Blagoue, was struck in the face and abdomen by 
     shotgun pellets, Johnson said. Blagoue was in stable 
     condition at the base hospital, where he was expected to stay 
     the night, officials said.
       The military police fired back at Comfort, Johnson said. 
     ``Whether they hit the suspect, we don't know,'' Beeman said.
       Additional gunfire was heard soon afterward from inside the 
     house. Military police surrounded the home and evacuated 
     nearby homes, officials said.
       The couple's girls, ages 4 and 2, were inside the home, 
     along with a woman, a family friend who has been stationed 
     overseas. It was not immediately clear whether the woman 
     entered the home before or after Michael Comfort arrived.
       ``We were told he was holding everybody hostage,'' Beeman 
     said.
       After several hours without contact with anyone inside the 
     town house, police forced their way into the home at 6:10 
     a.m. and found the friend and the two children unharmed and 
     both Comforts dead from shotgun wounds. Officials could not 
     immediately say why the friend did not try to contact police 
     in the three hours before police entered the home.
       ``We don't know why they didn't exit the home earlier,'' 
     Beeman said.
       Air Force spokesman could not say in which rooms the dead 
     couple, the children and the friend were found or the 
     location of the children at the time of the shootings.
       Johnson said Melissa Comfort, a petty officer second class 
     originally from Fairmont, N.C., who joined the Navy in 1986, 
     was assigned to the Office of Naval Intelligence in Suitland.

  The PRESIDING OFFICER. The Senator from West Virginia.
  Mr. BYRD. Mr. President, has the Pastore rule expired for the day?
  The PRESIDING OFFICER. Yes, it has.
  Mr. BYRD. I thank the Chair. Time is not controlled?
  The PRESIDING OFFICER. Time is not controlled.

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