[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.
____________________