[Congressional Record Volume 148, Number 97 (Wednesday, July 17, 2002)]
[Senate]
[Pages S6883-S6898]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
GREATER ACCESS TO AFFORDABLE PHARMACEUTICALS ACT OF 2001
The PRESIDING OFFICER. Under the previous order, the motion to
proceed is agreed to and the clerk will report the bill.
The assistant legislative clerk read as follows:
[[Page S6884]]
A bill (S. 812) to amend the Federal Food, Drug, and
Cosmetic Act to provide greater access to affordable
pharmaceuticals.
The Senate proceeded to consider the bill, which had been reported
from the Committee on Health, Education, Labor, and Pensions, with an
amendment, as follows:
(The parts of the bill intended to be stricken are shown in boldface
brackets and the parts of the bill intended to be inserted are shown in
italics.)
S. 812
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Greater Access to Affordable
Pharmaceuticals Act of 2001''.
SEC. 2. FINDINGS; PURPOSES.
(a) Findings.--Congress finds that--
(1) prescription drug costs are increasing at an alarming
rate and are a major worry of American families and senior
citizens;
(2) enhancing competition between generic drug
manufacturers and brand-name manufacturers can significantly
reduce prescription drug costs for American families;
(3) the pharmaceutical market has become increasingly
competitive during the last decade because of the increasing
availability and accessibility of generic pharmaceuticals,
but competition must be further stimulated and strengthened;
(4) the Federal Trade Commission has discovered that there
are increasing opportunities for drug companies owning
patents on brand-name drugs and generic drug companies to
enter into private financial deals in a manner that could
restrain trade and greatly reduce competition and increase
prescription drug costs for consumers;
(5) generic pharmaceuticals are approved by the Food and
Drug Administration on the basis of scientific testing and
other information establishing that pharmaceuticals are
therapeutically equivalent to brand-name pharmaceuticals,
ensuring consumers a safe, efficacious, and cost-effective
alternative to brand-name innovator pharmaceuticals;
(6) the Congressional Budget Office estimates that--
(A) the use of generic pharmaceuticals for brand-name
pharmaceuticals could save purchasers of pharmaceuticals
between $8,000,000,000 and $10,000,000,000 each year; and
(B) generic pharmaceuticals cost between 25 percent and 60
percent less than brand-name pharmaceuticals, resulting in an
estimated average savings of $15 to $30 on each prescription;
(7) generic pharmaceuticals are widely accepted by
consumers and the medical profession, as the market share
held by generic pharmaceuticals compared to brand-name
pharmaceuticals has more than doubled during the last decade,
from approximately 19 percent to 43 percent, according to the
Congressional Budget Office;
(8) expanding access to generic pharmaceuticals can help
consumers, especially senior citizens and the uninsured, have
access to more affordable prescription drugs;
(9) Congress should ensure that measures are taken to
effectuate the amendments made by the Drug Price Competition
and Patent Term Restoration Act of 1984 (98 Stat. 1585)
(referred to in this section as the ``Hatch-Waxman Act'') to
make generic drugs more accessible, and thus reduce health
care costs; and
(10) it would be in the public interest if patents on drugs
for which applications are approved under section 505(c) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c))
were extended only through the patent extension procedure
provided under the Hatch-Waxman Act rather than through the
attachment of riders to bills in Congress.
(b) Purposes.--The purposes of this Act are--
(1) to increase competition, thereby helping all Americans,
especially seniors and the uninsured, to have access to more
affordable medication; and
(2) to ensure fair marketplace practices and deter
pharmaceutical companies (including generic companies) from
engaging in anticompetitive action or actions that tend to
unfairly restrain trade.
SEC. 3. FILING OF PATENT INFORMATION WITH THE FOOD AND DRUG
ADMINISTRATION.
(a) Filing After Approval of an Application.--
(1) In General.--Section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355) (as amended by section
9(a)(2)(B)(ii)) is amended in subsection (c) by striking
paragraph (2) and inserting the following:
``(2) Patent information.--
``(A) In general.--Not later than the date that is 30 days
after the date of an order approving an application under
subsection (b) (unless the Secretary extends the date because
of extraordinary or unusual circumstances), the holder of the
application shall file with the Secretary the patent
information described in subparagraph (C) with respect to any
patent--
``(i)(I) that claims the drug for which the application was
approved; or
``(II) that claims an approved method of using the drug;
and
``(ii) with respect to which a claim of patent infringement
could reasonably be asserted if a person not licensed by the
owner engaged in the manufacture, use, or sale of the drug.
``(B) Subsequently issued patents.--In a case in which a
patent described in subparagraph (A) is issued after the date
of an order approving an application under subsection (b),
the holder of the application shall file with the Secretary
the patent information described in subparagraph (C) not
later than the date that is 30 days after the date on which
the patent is issued (unless the Secretary extends the date
because of extraordinary or unusual circumstances).
``(C) Patent information.--The patent information required
to be filed under subparagraph (A) or (B) includes--
``(i) the patent number;
``(ii) the expiration date of the patent;
``(iii) with respect to each claim of the patent--
``(I) whether the patent claims the drug or claims a method
of using the drug; and
``(II) whether the claim covers--
``(aa) a drug substance;
``(bb) a drug formulation;
``(cc) a drug composition; or
``(dd) a method of use;
``(iv) if the patent claims a method of use, the approved
use covered by the claim;
``(v) the identity of the owner of the patent (including
the identity of any agent of the patent owner); and
``(vi) a declaration that the applicant, as of the date of
the filing, has provided complete and accurate patent
information for all patents described in subparagraph (A).
``(D) Publication.--On filing of patent information
required under subparagraph (A) or (B), the Secretary shall--
``(i) immediately publish the information described in
clauses (i) through (iv) of subparagraph (C); and
``(ii) make the information described in clauses (v) and
(vi) of subparagraph (C) available to the public on request.
``(E) Civil action for correction or deletion of patent
information.--
``(i) In general.--A person that has filed an application
under subsection (b)(2) or (j) for a drug may bring a civil
action against the holder of the approved application for the
drug seeking an order requiring that the holder of the
application amend the application--
``(I) to correct patent information filed under
subparagraph (A); or
``(II) to delete the patent information in its entirety for
the reason that--
``(aa) the patent does not claim the drug for which the
application was approved; or
``(bb) the patent does not claim an approved method of
using the drug.
``(ii) Limitations.--Clause (i) does not authorize--
``(I) a civil action to correct patent information filed
under subparagraph (B); or
``(II) an award of damages in a civil action under clause
(i).
``(F) No claim for patent infringement.--An owner of a
patent with respect to which a holder of an application fails
to file information on or before the date required under
subparagraph (A) or (B) shall be barred from bringing a civil
action for infringement of the patent against a person that--
``(i) has filed an application under subsection (b)(2) or
(j); or
``(ii) manufactures, uses, offers to sell, or sells a drug
approved under an application under subsection (b)(2) or
(j).''.
(2) Transition provision.--
(A) Filing of patent information.--Each holder of an
application for approval of a new drug under section 505(b)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(b)) that has been approved before the date of enactment
of this Act shall amend the application to include the patent
information required under the amendment made by paragraph
(1) not later than the date that is 30 days after the date of
enactment of this Act (unless the Secretary of Health and
Human Services extends the date because of extraordinary or
unusual circumstances).
(B) No claim for patent infringement.--An owner of a patent
with respect to which a holder of an application under
subsection (b) of section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355) fails to file information on or
before the date required under subparagraph (A) shall be
barred from bringing a civil action for infringement of the
patent against a person that--
(i) has filed an application under subsection (b)(2) or (j)
of that section; or
(ii) manufactures, uses, offers to sell, or sells a drug
approved under an application under subsection (b)(2) or (j)
of that section.
(b) Filing With an Application.--Section 505 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended--
(1) in subsection (b)(2)--
(A) in subparagraph (A), by striking ``and'' at the end;
(B) in subparagraph (B), by striking the period at the end
and inserting ``; and''; and
(C) by adding at the end the following:
``(C) with respect to a patent that claims both the drug
and a method of using the drug or claims more than 1 method
of using the drug for which the application is filed--
``(i) a certification under subparagraph (A)(iv) on a
claim-by-claim basis; and
``(ii) a statement under subparagraph (B) regarding the
method of use claim.''; and
(2) in subsection (j)(2)(A), by inserting after clause
(viii) the following:
``With respect to a patent that claims both the drug and a
method of using the drug or claims more than 1 method of
using the drug for which the application is filed, the
application shall contain a certification under clause
(vii)(IV) on a claim-by-claim basis and a statement under
clause (viii) regarding the method of use claim.''.
[[Page S6885]]
SEC. 4. LIMITATION OF 30-MONTH STAY TO CERTAIN PATENTS.
(a) Abbreviated New Drug Applications.--Section 505(j)(5)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(5)) is amended--
(1) in subparagraph (B)--
(A) in clause (iii)--
(i) by striking ``(iii) If the applicant made a
certification described in subclause (IV) of paragraph
(2)(A)(vii),'' and inserting the following:
``(iii) Subclause (iv) certification with respect to
certain patents.--If the applicant made a certification
described in paragraph (2)(A)(vii)(IV) with respect to a
patent (other than a patent that claims a process for
manufacturing the listed drug) for which patent information
was filed with the Secretary under subsection (c)(2)(A),'';
and
(ii) by adding at the end the following: ``The 30-month
period provided under the second sentence of this clause
shall not apply to a certification under paragraph
(2)(A)(vii)(IV) made with respect to a patent for which
patent information was filed with the Secretary under
subsection (c)(2)(B).'';
(B) by redesignating clause (iv) as clause (v); and
(C) by inserting after clause (iii) the following:
``(iv) Subclause (iv) certification with respect to other
patents.--
``(I) In general.--If the applicant made a certification
described in paragraph (2)(A)(vii)(IV) with respect to a
patent not described in clause (iii) for which patent
information was published by the Secretary under subsection
(c)(2)(D), the approval shall be made effective on the date
that is 45 days after the date on which the notice provided
under paragraph (2)(B) was received, unless a civil action
for infringement of the patent, accompanied by a motion for
preliminary injunction to enjoin the applicant from engaging
in the commercial manufacture or sale of the drug, was filed
on or before the date that is 45 days after the date on which
the notice was received, in which case the approval shall be
made effective--
``(aa) on the date of a court action declining to grant a
preliminary injunction; or
``(bb) if the court has granted a preliminary injunction
prohibiting the applicant from engaging in the commercial
manufacture or sale of the drug--
``(AA) on issuance by a court of a determination that the
patent is invalid or is not infringed;
``(BB) on issuance by a court of an order revoking the
preliminary injunction or permitting the applicant to engage
in the commercial manufacture or sale of the drug; or
``(CC) on the date specified in a court order under section
271(e)(4)(A) of title 35, United States Code, if the court
determines that the patent is infringed.
``(II) Cooperation.--Each of the parties shall reasonably
cooperate in expediting a civil action under subclause (I).
``(III) Expedited notification.--If the notice under
paragraph (2)(B) contains an address for the receipt of
expedited notification of a civil action under subclause (I),
the plaintiff shall, on the date on which the complaint is
filed, simultaneously cause a notification of the civil
action to be delivered to that address by the next business
day.''; and
(2) by inserting after subparagraph (B) the following:
``(C) Failure to bring infringement action.--If, in
connection with an application under this subsection, the
applicant provides an owner of a patent notice under
paragraph (2)(B) with respect to the patent, and the owner of
the patent fails to bring a civil action against the
applicant for infringement of the patent on or before the
date that is 45 days after the date on which the notice is
received, the owner of the patent shall be barred from
bringing a civil action for infringement of the patent in
connection with the development, manufacture, use, offer to
sell, or sale of the drug for which the application was filed
or approved under this subsection.''.
(b) Other Applications.--Section 505(c)) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)) (as amended
by section 9(a)(3)(A)(iii)) is amended--
(1) in paragraph (3)--
(A) in subparagraph (C)--
(i) by striking ``(C) If the applicant made a certification
described in clause (iv) of subsection (b)(2)(A),'' and
inserting the following:
``(C) Clause (iv) certification with respect to certain
patents.--If the applicant made a certification described in
subsection (b)(2)(A)(iv) with respect to a patent (other than
a patent that claims a process for manufacturing the listed
drug) for which patent information was filed with the
Secretary under paragraph (2)(A),''; and
(ii) by adding at the end the following: ``The 30-month
period provided under the second sentence of this
subparagraph shall not apply to a certification under
subsection (b)(2)(A)(iv) made with respect to a patent for
which patent information was filed with the Secretary under
paragraph (2)(B).''; and
(B) by inserting after subparagraph (C) the following:
``(D) Clause (iv) certification with respect to other
patents.--
``(i) In general.--If the applicant made a certification
described in subsection (b)(2)(A)(iv) with respect to a
patent not described in subparagraph (C) for which patent
information was published by the Secretary under paragraph
(2)(D), the approval shall be made effective on the date that
is 45 days after the date on which the notice provided under
subsection (b)(3) was received, unless a civil action for
infringement of the patent, accompanied by a motion for
preliminary injunction to enjoin the applicant from engaging
in the commercial manufacture or sale of the drug, was filed
on or before the date that is 45 days after the date on which
the notice was received, in which case the approval shall be
made effective--
``(I) on the date of a court action declining to grant a
preliminary injunction; or
``(II) if the court has granted a preliminary injunction
prohibiting the applicant from engaging in the commercial
manufacture or sale of the drug--
``(aa) on issuance by a court of a determination that the
patent is invalid or is not infringed;
``(bb) on issuance by a court of an order revoking the
preliminary injunction or permitting the applicant to engage
in the commercial manufacture or sale of the drug; or
``(cc) on the date specified in a court order under section
271(e)(4)(A) of title 35, United States Code, if the court
determines that the patent is infringed.
``(ii) Cooperation.--Each of the parties shall reasonably
cooperate in expediting a civil action under clause (i).
``(iii) Expedited notification.--If the notice under
subsection (b)(3) contains an address for the receipt of
expedited notification of a civil action under clause (i),
the plaintiff shall, on the date on which the complaint is
filed, simultaneously cause a notification of the civil
action to be delivered to that address by the next business
day.''; and
(2) by inserting after paragraph (3) the following:
``(4) Failure to bring infringement action.--If, in
connection with an application under subsection (b)(2), the
applicant provides an owner of a patent notice under
subsection (b)(3) with respect to the patent, and the owner
of the patent fails to bring a civil action against the
applicant for infringement of the patent on or before the
date that is 45 days after the date on which the notice is
received, the owner of the patent shall be barred from
bringing a civil action for infringement of the patent in
connection with the development, manufacture, use, offer to
sell, or sale of the drug for which the application was filed
or approved under subsection (b)(2).''.
(c) Effective Date.--
(1) In general.--The amendments made by subsections (a) and
(b) shall be effective with respect to any certification
under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of
section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355) made after the date of enactment of this Act in
an application filed under subsection (b)(2) or (j) of that
section.
(2) Transition provision.--In the case of applications
under section 505(b) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(b)) filed before the date of enactment of
this Act--
(A) a patent (other than a patent that claims a process for
manufacturing a listed drug) for which information was
submitted to the Secretary of Health and Human Services under
section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act
(as in effect on the day before the date of enactment of this
Act) shall be subject to subsections (c)(3)(C) and
(j)(5)(B)(iii) of section 505 of the Federal Food, Drug, and
Cosmetic Act (as amended by this section); and
(B) any other patent (including a patent for which
information was submitted to the Secretary under section
505(c)(2) of that Act (as in effect on the day before the
date of enactment of this Act)) shall be subject to
subsections (c)(3)(D) and (j)(5)(B)(iv) of section 505 of the
Federal Food, Drug, and Cosmetic Act (as amended by this
section).
SEC. 5. EXCLUSIVITY FOR ACCELERATED GENERIC DRUG APPLICANTS.
(a) In General.--Section 505(j)(5) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)) (as amended by
section 4(a)) is amended--
(1) in subparagraph (B)(v), by striking subclause (II) and
inserting the following:
``(II) the earlier of--
``(aa) the date of a final decision of a court (from which
no appeal has been or can be taken, other than a petition to
the Supreme Court for a writ of certiorari) holding that the
patent that is the subject of the certification is invalid or
not infringed; or
``(bb) the date of a settlement order or consent decree
signed by a Federal judge that enters a final judgment and
includes a finding that the patent that is the subject of the
certification is invalid or not infringed;''; and
(2) by inserting after subparagraph (C) the following:
``(D) Forfeiture of 180-day period.--
``(i) Definitions.--In this subparagraph:
``(I) Application.--The term `application' means an
application for approval of a drug under this subsection
containing a certification under paragraph (2)(A)(vii)(IV)
with respect to a patent.
``(II) First application.--The term `first application'
means the first application to be filed for approval of the
drug.
``(III) Forfeiture event.--The term `forfeiture event',
with respect to an application under this subsection, means
the occurrence of any of the following:
``(aa) Failure to market.--The applicant fails to market
the drug by the later of--
``(AA) the date that is 60 days after the date on which the
approval of the application for the drug is made effective
under clause (iii) or (iv) of subparagraph (B) (unless the
Secretary extends the date because of extraordinary or
unusual circumstances); or
``(BB) if 1 or more civil actions have been brought against
the applicant for infringement of a patent subject to a
certification under paragraph (2)(A)(vii)(IV) or 1 or more
civil actions have been brought by the applicant for a
declaratory judgment that such a patent is invalid or not
infringed, the date that is 60 days after the date of a final
decision (from which no appeal
[[Page S6886]]
has been or can be taken, other than a petition to the
Supreme Court for a writ of certiorari) in the last of those
civil actions to be decided (unless the Secretary extends the
date because of extraordinary or unusual circumstances).
``(bb) Withdrawal of application.--The applicant withdraws
the application.
``(cc) Amendment of certification.--The applicant,
voluntarily or as a result of a settlement or defeat in
patent litigation, amends the certification from a
certification under paragraph (2)(A)(vii)(IV) to a
certification under paragraph (2)(A)(vii)(III).
``(dd) Failure to obtain approval.--The applicant fails to
obtain tentative approval of an application within 30 months
after the date on which the application is filed, unless the
failure is caused by--
``(AA) a change in the requirements for approval of the
application imposed after the date on which the application
is filed; or
``(BB) other extraordinary circumstances warranting an
exception, as determined by the Secretary.
``(ee) Failure to challenge patent.--In a case in which,
after the date on which the applicant submitted the
application, new patent information is submitted under
subsection (c)(2) for the listed drug for a patent for which
certification is required under paragraph (2)(A), the
applicant fails to submit, not later than the date that is 60
days after the date on which the Secretary publishes the new
patent information under paragraph (7)(A)(iii) (unless the
Secretary extends the date because of extraordinary or
unusual circumstances)--
``(AA) a certification described in paragraph
(2)(A)(vii)(IV) with respect to the patent to which the new
patent information relates; or
``(BB) a statement that any method of use claim of that
patent does not claim a use for which the applicant is
seeking approval under this subsection in accordance with
paragraph (2)(A)(viii).
``(ff) Unlawful conduct.--The Federal Trade Commission
determines that the applicant engaged in unlawful conduct
with respect to the application in violation of section 1 of
the Sherman Act (15 U.S.C. 1).
``(IV) Subsequent application.--The term `subsequent
application' means an application for approval of a drug that
is filed subsequent to the filing of a first application for
approval of that drug.
``(ii) Forfeiture of 180-day period.--
``(I) In general.--Except as provided in subclause (II), if
a forfeiture event occurs with respect to a first
application--
``(aa) the 180-day period under subparagraph (B)(v) shall
be forfeited by the first applicant; and
``(bb) any subsequent application shall become effective as
provided under clause (i), (ii), (iii), or (iv) of
subparagraph (B), and clause (v) of subparagraph (B) shall
not apply to the subsequent application.
``(II) Forfeiture to first subsequent applicant.--If the
subsequent application that is the first to be made effective
under subclause (I) was the first among a number of
subsequent applications to be filed--
``(aa) that first subsequent application shall be treated
as the first application under this subparagraph (including
subclause (I)) and as the previous application under
subparagraph (B)(v); and
``(bb) any other subsequent applications shall become
effective as provided under clause (i), (ii), (iii), or (iv)
of subparagraph (B), but clause (v) of subparagraph (B) shall
apply to any such subsequent application.
``(iii) Availability.--The 180-day period under
subparagraph (B)(v) shall be available to a first applicant
submitting an application for a drug with respect to any
patent without regard to whether an application has been
submitted for the drug under this subsection containing such
a certification with respect to a different patent.
``(iv) Applicability.--The 180-day period described in
subparagraph (B)(v) shall apply to an application only if a
civil action is brought against the applicant for
infringement of a patent that is the subject of the
certification.''.
(b) Applicability.--The amendment made by subsection (a)
shall be effective only with respect to an application filed
under section 505(j) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(j)) after the date of enactment of this
Act for a listed drug for which no certification under
section 505(j)(2)(A)(vii)(IV) of that Act was made before the
date of enactment of this Act, except that if a forfeiture
event described in section 505(j)(5)(D)(i)(III)(ff) of that
Act occurs in the case of an applicant, the applicant shall
forfeit the 180-day period under section 505(j)(5)(B)(v) of
that Act without regard to when the applicant made a
certification under section 505(j)(2)(A)(vii)(IV) of that
Act.
SEC. 6. FAIR TREATMENT FOR INNOVATORS.
(a) Basis for Application.--Section 505 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended--
(1) in subsection (b)(3)(B), by striking the second
sentence and inserting ``The notice shall include a detailed
statement of the factual and legal basis of the applicant's
opinion that, as of the date of the notice, the patent is not
valid or is not infringed, and shall include, as appropriate
for the relevant patent, a description of the applicant's
proposed drug substance, drug formulation, drug composition,
or method of use. All information disclosed under this
subparagraph shall be treated as confidential and may be used
only for purposes relating to patent adjudication. Nothing in
this subparagraph precludes the applicant from amending the
factual or legal basis on which the applicant relies in
patent litigation.''; and
(2) in subsection (j)(2)(B)(ii), by striking the second
sentence and inserting ``The notice shall include a detailed
statement of the factual and legal basis of the opinion of
the applicant that, as of the date of the notice, the patent
is not valid or is not infringed, and shall include, as
appropriate for the relevant patent, a description of the
applicant's proposed drug substance, drug formulation, drug
composition, or method of use. All information disclosed
under this subparagraph shall be treated as confidential and
may be used only for purposes relating to patent
adjudication. Nothing in this subparagraph precludes the
applicant from amending the factual or legal basis on which
the applicant relies in patent litigation.''.
(b) Injunctive Relief.--Section 505(j)(5)(B) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)) (as
amended by section 4(a)(1)) is amended--
(1) in clause (iii), by adding at the end the following:
``A court shall not regard the extent of the ability of an
applicant to pay monetary damages as a whole or partial basis
on which to deny a preliminary or permanent injunction under
this clause.''; and
(2) in clause (iv), by adding at the end the following:
``(IV) Injunctive relief.--A court shall not regard the
extent of the ability of an applicant to pay monetary damages
as a whole or partial basis on which to deny a preliminary or
permanent injunction under this clause.''.
SEC. 7. BIOEQUIVALENCE.
(a) In General.--The amendments to part 320 of title 21,
Code of Federal Regulations, promulgated by the Commissioner
of Food and Drugs on July 17, 1991 (57 Fed. Reg. 17997 (April
28, 1992)), shall continue in effect as an exercise of
authorities under sections 501, 502, 505, and 701 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352,
355, 371).
(b) Effect.--Subsection (a) does not affect the authority
of the Commissioner of Food and Drugs to amend part 320 of
title 21, Code of Federal Regulations.
(c) Effect of Section.--This section shall not be construed
to alter the authority of the Secretary of Health and Human
Services to regulate biological products under the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). Any
such authority shall be exercised under that Act as in effect
on the day before the date of enactment of this Act.
SEC. 8. REPORT.
(a) In General.--Not later than the date that is 5 years
after the date of enactment of this Act, the Federal Trade
Commission shall submit to Congress a report describing the
extent to which implementation of the amendments made by this
Act--
(1) has enabled products to come to market in a fair and
expeditious manner, consistent with the rights of patent
owners under intellectual property law; and
(2) has promoted lower prices of drugs and greater access
to drugs through price competition.
(b) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section $5,000,000.
SEC. 9. CONFORMING AND TECHNICAL AMENDMENTS.
(a) Section 505.--Section 505 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355) is amended--
(1) in subsection (a), by striking ``(a) No person'' and
inserting ``(a) In General.--No person'';
(2) in subsection (b)--
(A) by striking ``(b)(1) Any person'' and inserting the
following:
``(b) Applications.--
``(1) Requirements.--
``(A) In general.--Any person'';
(B) in paragraph (1)--
(i) in the second sentence--
(I) by redesignating subparagraphs (A) through (F) as
clauses (i) through (vi), respectively, and adjusting the
margins appropriately;
(II) by striking ``Such persons'' and inserting the
following:
``(B) Information to be submitted with application.--A
person that submits an application under subparagraph (A)'';
and
(III) by striking ``application'' and inserting
``application--'';
(ii) by striking the third through fifth sentences; and
(iii) in the sixth sentence--
(I) by striking ``The Secretary'' and inserting the
following:
``(C) Guidance.--The Secretary''; and
(II) by striking ``clause (A)'' and inserting
``subparagraph (B)(i)''; and
(C) in paragraph (2)--
(i) by striking ``clause (A) of such paragraph'' and
inserting ``paragraph (1)(B)(i)'';
(ii) in subparagraphs (A) and (B), by striking ``paragraph
(1) or''; and
(iii) in subparagraph (B)--
(I) by striking ``paragraph (1)(A)'' and inserting
``paragraph (1)(B)(i)''; and
(II) by striking ``patent'' each place it appears and
inserting ``claim''; and
(3) in subsection (c)--
(A) in paragraph (3)--
(i) in subparagraph (A)--
(I) by striking ``(A) If the applicant'' and inserting the
following:
``(A) Clause (i) or (ii) certification.--If the
applicant''; and
(II) by striking ``may'' and inserting ``shall'';
(ii) in subparagraph (B)--
(I) by striking ``(B) If the applicant'' and inserting the
following:
``(B) Clause (iii) certification.--If the applicant''; and
(II) by striking ``may'' and inserting ``shall'';
(iii) by redesignating subparagraph (D) as subparagraph
(E); and
(iv) in subparagraph (E) (as redesignated by clause (iii)),
by striking ``clause (A) of subsection (b)(1)'' each place it
appears and inserting ``subsection (b)(1)(B)(i)''; and
[[Page S6887]]
(B) by redesignating paragraph (4) as paragraph (5); and
(4) in subsection (j)--
(A) in paragraph (2)(A)--
(i) in clause (vi), by striking ``clauses (B) through
((F)'' and inserting ``subclauses (ii) through (vi) of
subsection (b)(1)'';
(ii) in clause (vii), by striking ``(b) or''; and
(iii) in clause (viii)--
(I) by striking ``(b) or''; and
(II) by striking ``patent'' each place it appears and
inserting ``claim''; and
(B) in paragraph (5)--
(i) in subparagraph (B)--
(I) in clause (i)--
(aa) by striking ``(i) If the applicant'' and inserting the
following:
``(i) Subclause (i) or (ii) certification.--If the
applicant''; and
(bb) by striking ``may'' and inserting ``shall'';
(II) in clause (ii)--
(aa) by striking ``(ii) If the applicant'' and inserting
the following:
``(i) Subclause (iii) certification.--If the applicant'';
and
(bb) by striking ``may'' and inserting ``shall'';
(III) in clause (iii), by striking ``(2)(B)(i)'' each place
it appears and inserting ``(2)(B)''; and
(IV) in clause (v) (as redesignated by section 4(a)(1)(B)),
by striking ``continuing'' and inserting ``containing''; and
(ii) by redesignating subparagraphs (C) and (D) as
subparagraphs (E) and (F), respectively.
(b) Section 505A.--Section 505A of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355a) is amended--
(1) in subsections (b)(1)(A)(i) and (c)(1)(A)(i)--
(A) by striking ``(c)(3)(D)(ii)'' each place it appears and
inserting ``(c)(3)(E)(ii)''; and
(B) by striking ``(j)(5)(D)(ii)'' each place it appears and
inserting ``(j)(5)(F)(ii)'';
(2) in subsections (b)(1)(A)(ii) and (c)(1)(A)(ii)--
(A) by striking ``(c)(3)(D)'' each place it appears and
inserting ``(c)(3)(E)''; and
(B) by striking ``(j)(5)(D)'' each place it appears and
inserting ``(j)(5)(F)'';
(3) in subsections (e) and (l)--
(A) by striking ``505(c)(3)(D)'' each place it appears and
inserting ``505(c)(3)(E)''; and
(B) by striking ``505(j)(5)(D)'' each place it appears and
inserting ``505(j)(5)(F)''; and
(4) in subsection (k), by striking ``505(j)(5)(B)(iv)'' and
inserting ``505(j)(5)(B)(v)''.
(c) Section 527.--Section 527(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360cc(a)) is amended in the
second sentence by striking ``505(c)(2)'' and inserting
``505(c)(1)(B)''.
The PRESIDING OFFICER. The majority leader.
Mr. DASCHLE. Mr. President, I will propound a unanimous consent
request. It has been agreed to on both sides. And then I would like to
put the Senate in a quorum call so we might proceed in an organized
way. I think we are just about there.
I ask unanimous consent that the committee-reported amendment be
considered and agreed to, and the motion to reconsider be laid upon the
table; that the bill, as thus amended, be considered as original text
for the purpose of further amendment; that no points of order be
considered waived by virtue of this agreement.
The PRESIDING OFFICER. Is there objection?
Without objection, it is so ordered.
The committee amendment was agreed to.
Mr. DASCHLE. I suggest the absence of a quorum.
The PRESIDING OFFICER. The clerk will call the roll.
The assistant legislative clerk proceeded to call the roll.
Mr. REID. Madam President, I ask unanimous consent that the order for
the quorum call be rescinded.
The PRESIDING OFFICER (Ms. Stabenow). Without objection, it is so
ordered.
Mr. REID. Madam President, I ask unanimous consent the Senator from
Arizona be recognized for up to 15 minutes and that I get the floor
following the completion of his statement.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. REID. The Senator from Arizona has indicated this is for debate
only.
The PRESIDING OFFICER. Without objection, it is so ordered.
The Senator from Arizona is recognized for up to 15 minutes.
Mr. McCAIN. Madam President, I thank the Senator from Nevada.
It is time to talk about the bill that is before us which, as we all
know, is going to be used as a vehicle to attempt to address the very
controversial issue of prescription drug benefits for Medicare.
I also thank the Senator from Massachusetts for passing this bill
through his committee and reporting it to the floor.
I thank especially Senator Schumer who really is the person
responsible for this legislation. All of us like to take credit for
things in this body. The fact is, the reality is, Senator Schumer
brought this issue, certainly the idea for this legislation, to my
attention. He is the one who really worked on it. I am grateful he
included me in this very important issue.
It is important to the people of my State and to all Americans. As we
all know, there are large numbers of retirees who have been intelligent
enough to move from New York to Arizona, and they are deeply affected
by the cost of prescription drugs.
Mr. SCHUMER. Will the Senator yield for a brief comment?
Mr. McCAIN. I am glad to yield to the Senator from New York.
Mr. SCHUMER. I thank my friend. I want to thank him. We have been in
this together from the beginning--almost 2 years ago, when we realized
that something had to be done. His steadfastness, his courage, and his
constant efforts to refine the legislation and make it better and make
sure we bring it to the floor has been a large part of why we are here.
I thank the Senator for being a great colleague with whom to work. I
wanted to repay the accolades and compliment of the Senator.
Mr. McCAIN. I thank my friend from New York. Again, I reiterate that
he really is the one who has been the leader in this issue and in this
legislation. He is also well known for his tenacity.
Madam President, first of all, I think we also ought to understand
that this issue alone--that of getting affordable drugs to all
Americans--obviously, as I spoke of before, particularly seniors and
those on fixed retirement incomes are the ones most dramatically
affected. That is a critical issue in America today. I don't claim that
this bill before us solves the problem of providing prescription drugs
for all Americans, particularly seniors, but I do argue that this is a
very important step in the right direction in lowering the cost of
prescription drugs to all Americans.
Now, the drug companies have mounted a massive attack on this
legislation. They were the major contributors in recent fundraisers on
both sides of the aisle. It is not complicated. The bill is not
complicated. It only has three or four provisions. Basically, what it
achieves is an ability to do what the Hatch-Waxman bill was intended to
do, and that is to make available generic drugs as early as possible,
with respect for the rights of those who invested massive amounts of
money, in many cases, in research and development and testing, and for
them to have an adequate return on their investment. There is no intent
here to harm the drug companies. What it is intended to do is to get
drugs to the market in the generic fashion so people would only have to
pay less.
Madam President, Allen Feezor, CalPERS' Assistant Executive Officer
for Health Benefits, said:
In two of the past three years, pharmaceutical costs have
increased more than any other component in our CalPERS health
rate.
CalPERS is the retirement plan for California employees, which are
very large in number.
In our Medicare Choice/Supplemental plans, pharmacy trend
can account for over 50 percent of the increase in premium
rates that we see in our retiree plans one year to the next.
The obvious result is very clear. Every year, prescription drugs
become less and less affordable to all Americans but especially
retirees. It should be noted. He goes on to say:
It should be noted that in both our hospital and
[prescription drug] trends, a measurable portion of the trend
is due to increased utilization by our enrollees, but this
cannot take away from the extraordinarily high trends in both
pharmacy and hospital pricing.
The rising cost of prescription drugs is also playing a significant
role in the growing financial burden companies experience as they
struggle to provide employees with health care coverage. For example,
General Motors, the largest provider of private sector health care
coverage, spends over $4 billion a year to insure over 1.2 million
workers, retirees and their dependents, $1.3 billion of which is on
prescription drugs alone. Even with aggressive cost-saving mechanisms
in place, GM's prescription drug costs continue to rise between 15
percent and 20 percent per year.
Given the crises in both corporate America and our Nation's health
care
[[Page S6888]]
system, anticompetitive behavior in the marketplace is particularly
onerous. That is what we are trying to get at, the anticompetitive
behavior. This legislation is intended not to weaken patent laws to the
detriment of the pharmaceutical industry, nor is it to impede the
tremendous investments they make in the research and development of new
drugs. The purpose of the underlying legislation is to close loopholes
in the Hatch-Waxman act, and to ensure more timely access to generic
medications. This is an important distinction which must be made clear.
However, to believe that patent laws are not being abused is to
ignore the mountain of testimony from consumers, industry analysts, and
the Federal Trade Commission. The Commerce Committee heard testimony
regarding the extent by which pharmaceutical companies, including
generic manufacturers, engage in anticompetitive activities and impede
access to affordable medications. During that hearing, Chairman Muris,
of the FTC, testified:
In spite of this remarkable record of success, the Hatch-
Waxman amendments have also been subject to abuse. Although
many drug manufacturers, including both branded companies and
generics, have acted in good faith, some have attempted to
``game'' the system, securing greater profits for themselves
without providing a corresponding benefit to consumers.
The intent of the Hatch-Waxman act was to address the escalating
costs of prescription drugs by encouraging generic competition, while
at the same time providing incentives for brand name drug companies to
continue research and development into new and more advanced drugs. To
a large extent, Hatch-Waxman has succeeded in striking that difficult
balance between bringing new lower cost alternatives to consumers,
while encouraging more investment in U.S. pharmaceutical research and
development.
In the 15 years since the enactment of Hatch-Waxman, research and
development has increased from $3 billion to $21 billion. However, some
bad actors have manipulated the law in a manner that delays and, at
times, prohibits generics from entering the marketplace.
I believe this legislation will improve the current system while
preserving the intent of Hatch-Waxman. This legislation is not an
attempt to jeopardize the patent rights of innovative companies, nor
does it seek to provide unfair advantage to generic manufacturers.
Rather, the intent of this legislation is to strike a balance between
these two interests so that we can close the loopholes that allow some
companies to engage in anticompetitive actions by unfairly prolonging
patents or eliminating fair competition. In doing so, we offer
consumers more choice in the marketplace.
It is imperative that Congress build upon the strengths of our
current health care system while addressing its weaknesses. This should
not be done by imposing price controls or creating a universal,
Government-run health care system. Rather, a balance must be found that
protects consumers with market-based, competitive solutions without
allowing those protections to be manipulated at the consumers' expense,
particularly senior citizens and working families without health care
insurance.
Madam President, today, there are probably buses leaving places in
the Northeast and in the Southwest, loaded with seniors who are going
either to Mexico or Canada to purchase drugs, which will probably cost
them around half of what they would at their local pharmacy. There are
people today, as we speak, who are making a choice between their health
and their income. That is wrong. It is wrong. It is wrong when patent
drug companies game the system by doing things like bringing suits,
which then delays the implementation. It is wrong when the patent drug
companies actually pay generic drug companies not to produce a
particular prescription drug while they continue their profits, and it
is wrong to game this system.
So here we are with a bill that with proper debate and perhaps
amendments, could be passed by this body and is supported by an
overwhelming number of consumer organizations. Even the patent drug
companies and the generic drug companies themselves will admit that we
need to make reforms.
Unfortunately, this statement that I have made and those made by
Senator Schumer may be the only debate we have on this legislation
which could be passed between now and September. So what are we going
to do? What we are really going to do is have a debate over the
prescription drug issue, Medicare, and that will bog us down with
competing proposals, all of which will require 60 votes, and none of
which has the 60 votes. At the end of 2 weeks, rather than passing this
bill, which we should, we are going to say, oops, we really cannot come
to an agreement, and if we did have an agreement, the House bill is
very different, and we would have to go to a conference, from which
bills would never emerge.
I think the American people deserve better. Why do we not pass this
underlying bill, or at least make a commitment to pass this underlying
bill, if the competing proposals that will be before us on Medicare
prescription drugs do not receive 60 votes?
What I am afraid is going to happen is that none of the three will
receive 60 votes. Then we will drop the bill and move on to other
issues, and I think that is wrong. I think we know that with this
approach, this underlying legislation, with some changes, absent, of
course, the huge campaign contributions of the drug companies, we could
reach an agreement which would be fair to the prescription drug
companies, fair to the generics, and fair to the American public, and,
indeed, in the view of anyone, including a recent study by the Federal
Trade Commission that shows that these abuses are having a direct
impact on the increasing costs of prescription drugs to all Americans
particularly.
I remind my colleagues that we may be doing an injustice and a
disservice to Americans for this year by not addressing this particular
aspect of it and having it encumbered and bogged down by competing
proposals.
I believe this legislation is fairly simple. It passed through the
committee of jurisdiction with half of the Republican members voting
for it. I know Senator Gregg, the ranking member, has some problems
with it. I think with debate, amendment, and discussion, we could
resolve those concerns that we might have and move forward.
Mr. GREGG. Will the Senator yield for a question?
Mr. McCAIN. I would be glad to yield.
Mr. GREGG. The Senator characterizes my views accurately, and I agree
with the Senator that this bill should be moved independent of the drug
bill. Unfortunately, the greater issue, or game, of the drug fight has
been set up to lose so that nothing will happen, as the Senator from
Arizona so appropriately pointed out. I do think this is important
legislation. I hope we will pass it somehow.
My concerns go to the expansion of lawsuits under the new cause of
action. Much of the rest of the bill--in fact the vast majority of the
rest of the bill--I think is excellent. I appreciate the work of the
Senator from Arizona in bringing it forward.
The PRESIDING OFFICER. The Senator's time has expired.
Mr. McCAIN. I ask unanimous consent for an additional 5 minutes, for
debate purposes only.
Mr. REID. Under the same conditions we put forward earlier.
The PRESIDING OFFICER. There is no objection under the same
conditions: When the Senator has completed, the Senator from Nevada
will be recognized.
Mr. McCAIN. I thank the Senator from Nevada.
Again, I thank the Senator from Massachusetts for getting this bill
through the committee. I thank Senator Gregg from New Hampshire for his
willingness to work with us, even though he has a couple of concerns
that I think we could work out.
I urge my colleagues again, if the Medicare prescription drug issue
is not resolved, to go back to the underlying bill, pass it, and
perhaps we can give the American people at least some relief between
now and next year.
This issue is not going away. Maybe after this year's elections we
could try to address it in a more nonpartisan fashion.
On another issue, very briefly, in this morning's Washington Post
there is an article by Mr. Andrew Grove, who is the chairman of the
Intel Corporation.
[[Page S6889]]
I believe he is one of the most respected men in America. He makes a
case that is very important. He outlines some of the changes he thinks
need to be made in the area of increasing corporate responsibility. I
think it is worthwhile to be included in the Record.
I ask unanimous consent that the article appearing in the Washington
Post by Andrew S. Grove called ``Stigmatizing Business'' be printed in
the Record.
There being no objection, the article was ordered to be printed in
the Record, as follows:
Stigmatizing Business
(By Andrew S. Grove)
I grew up in Communist Hungary. Even though I graduated
from high school with excellent grades, I had no chance of
being admitted to college because I was labeled a ``class
alien.'' What earned me this classification was the mere fact
that my father had been a businessman. It's hard to describe
the feelings of an 18-year-old as he grasps the nature of a
social stigma directed at him. But never did I think that,
nearly 50 years later and in a different country, I would
feel some of the same emotions and face a similar stigma.
Over the past few weeks, in reaction to a series of
corporate scandals, the pendulum of public feeling has swung
from celebrating business executives as the architects of
economic growth to condemning them as a group of
untrustworthy, venal individuals.
I have been with Intel since its inception 34 years ago.
During that time we have become the world's largest chip
manufacturer and have grown to employ 50,000 workers in the
United States, whose average pay is around $70,000 a year.
Thousands of our employees have bought houses and put their
children through college using money from stock options. A
thousand dollars invested in the company when it went public
in 1971 would be worth about $1 million today, so we have
made many investors rich as well.
I am proud of what our company has achieved. I should also
feel energized to deal with the challenges of today since we
are in one of the deepest technology recessions ever.
Instead, I'm having a hard time keeping my mind on our
business. I feel hunted, suspect--a ``class alien'' again.
I know I'm not alone in feeling this way. Other honest,
hard-working and capable business leaders feel similarly
demoralized by a political climate that has declared open
season on corporate executives and has let the faults,
however egregious, of a few taint the public perception of
all. This just at a time when their combined energy and
concentration are what's needed to reinvigorate our economy.
Moreover, I wonder if the reflexive reaction of focusing all
energies on punishing executives will address the problems
that have emerged over the past year.
Today's situation reminds me of an equally serious attack
on American business, one that required an equally serious
response. In the 1980s American manufacturers in industries
ranging from automobiles to semiconductors to photocopiers
were threatened by a flood of high-quality Japanese goods
produced at lower cost. Competing with these products exposed
the inherent weakness in the quality of our own products. It
was a serious threat. At first, American manufacturers
responded by inspecting their products more rigorously,
putting ever-increasing pressure on their quality assurance
organizations. I know this firsthand because this is what we
did at Intel.
Eventually, however, we and other manufacturers realized
that if the products were of inherently poor quality, no
amount of inspection would turn them into high-quality goods.
After much struggle--hand-wringing, finger-pointing,
rationalizing and attempts at damage control--we finally
concluded that the entire system of designing and
manufacturing goods, as well as monitoring the production
process, had to be changed. Quality could only be fixed by
addressing the entire cycle, from design to shipment to the
customer. This rebuilding from top to bottom led to the
resurgence of U.S. manufacturing
Corporate misdeeds, like poor quality, are a result of a
systemic problem, and a systemic problem requires a systemic
solution. I believe the solutions that are needed all fit
under the banner of ``separation of powers.''
Let's start with the position of chairman of the board of
directors. I think it is universally agreed that the
principal function of the board is to supervise and, if need
be, replace the CEO. Yet, in most American corporations, the
board chairman is the CEO. This poses a built-in conflict.
Reform should start with separating these two functions. (At
various times in Intel's history we have combined the
functions, but no longer). Furthermore stock exchanges should
require that boards of directors be predominantly made up of
independent members having no financial relationship with the
company. Separation of the offices of chairman and CEO, and a
board with something like a two-thirds majority of
independent directors, should be a condition for listing on
stock exchanges.
In addition, auditors should provide only one service:
auditing. Many auditing firms rely on auxiliary services to
make money, but if the major stock exchanges made auditing by
``pure'' firms a condition for listing, auditing would go
from being a loss leader for these companies to a profitable
undertaking. Would this drive the cost of auditing up? Beyond
a doubt. That's a cost of reform.
Taking the principle a step further, financial analysts
should be independent of the investment banks that do
business with corporations, a condition that could do
business with corporations, a condition that could and should
be required and monitored by the Securities and Exchange
Commission.
The point is this: The chairman, board of directors, CEO,
CFO, accountants and analysts could each stop a debacle from
developing. A systemic approach to ensuring the separation of
powers would put them in a position where they would be free
and motivated to take action.
I am not against prosecuting individuals responsible for
financial chicanery and other bad behavior. In fact, this
must be done. But tarring and feathering CEOs and CFOs as a
class will not solve the underlying problem. Restructuring
and strengthening the entire system of checks and balances of
the institutions that make up and monitor the U.S. capital
markets would serve us far better.
Reworking design, engineering and manufacturing processes
to meet the quality challenge from the Japanese in the 1980s
took five to 10 years. It was motivated by tremendous losses
in market share and employment. Similarly, the tremendous
loss of market value from the recent scandals provides a
strong motivation for reform. But let us not kid ourselves.
Effective reform will take years of painstaking
reconstruction.
Our society faces huge problems. Many of our citizens have
no access to health care; some of our essential
infrastructure is deteriorating; the war on terror and our
domestic security require additional resources. Attacking
these problems requires a vital economy. Shouldn't we take
time to think through how we can address the very real
problems in our corporations without demonizing and
demoralizing the managers whose entrepreneurial energy is
needed to drive our economy?
Mr. McCAIN. I will read the last paragraph of Mr. Grove's column. He
said:
Our society faces huge problems. Many of our citizens have
no access to health care; some of our essential
infrastructure is deteriorating; the war on terror and our
domestic security require additional resources. Attacking
these problems requires a vital economy. Shouldn't we take
time to think through how we can address the very real
problems in our corporations without demonizing and
demoralizing the managers whose entrepreneurial energy is
needed to drive our economy?
I might point out that a number of the proposals Mr. Grove has made
are not incorporated in the Sarbanes bill, and if we have to go back
and revisit this issue, which I am afraid we might, I hope everyone
will pay attention to some of his proposals.
As is well known to most of us, Mr. Grove grew up in Communist
Hungary, escaped at a very early age. He wrote a marvelous book about
it. It is a great American success story. I think he is one of the most
respected men in America. He has been at Intel since its inception 34
years ago, and it has become the world's largest chip manufacturer and
grown to employ 50,000 workers in the United States, whose average pay
is around $70,000 a year.
So I hope we will pay attention to Mr. Grove's recommendations, as
well as his statements of principle.
I thank my colleagues for allowing me to debate the bill, and I yield
back the remainder of my time.
Mr. REID. I suggest the absence of a quorum.
The PRESIDING OFFICER. The clerk will call the roll.
The assistant legislative clerk proceeded to call the roll.
Mr. REID. Madam President, I ask unanimous consent that the order for
the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
Amendment No. 4299
(Purpose: To permit commercial importation of prescription drugs from
Canada)
Mr. REID. Madam President, I send an amendment to the desk on behalf
of Senators Dorgan, Wellstone, and Stabenow.
The PRESIDING OFFICER. The clerk will report.
The legislative clerk read as follows:
The Senator from Nevada [Mr. Reid], for Mr. Dorgan, Mr.
Wellstone, Mr. Jeffords, Ms. Stabenow, Ms. Collins, Mr.
Levin, Mr. Johnson, Mr. Miller, Mr. Durbin, and Mr. Feingold,
proposes an amendment numbered 4299.
Mr. REID. I ask unanimous consent reading of the amendment be
dispensed with.
The PRESIDING OFFICER. Without objection, it is so ordered.
(The amendment is printed in today's Record under ``Text of
Amendments.'')
[[Page S6890]]
Mr. REID. Mr. President, I ask for the yeas and nays on this
amendment.
The PRESIDING OFFICER. Is there a sufficient second? There is a
sufficient second. The yeas and nays are ordered.
Amendment No. 4300 to Amendment No. 4299
(Purpose: To provide a substitute for the amendment)
Mr. REID. I send an amendment to the desk.
The PRESIDING OFFICER. The clerk will report.
The legislative clerk read as follows:
The Senator from Nevada [Mr. Reid], for Mr. Dorgan,
proposes an amendment numbered 4300 to amendment No. 4299.
Mr. REID. Madam President, I ask unanimous consent reading of the
amendment be dispensed with.
The PRESIDING OFFICER. Without objection, it is so ordered.
(The amendment is printed in today's Record under ``Text of
Amendments.'')
Mr. REID. Madam President, we appreciate the cooperation of the
managers of this bill. At this point, we are now going to be in a
posture to debate drug reimportation. We would hope we could have time
agreements on this on whatever the minority wishes to offer.
Prior to that, I ask unanimous consent the Senator from Maine, Ms.
Snowe, be recognized for 20 minutes to speak on the bill, or whatever
she chooses to speak on.
The PRESIDING OFFICER. Without objection, it is so ordered.
Ms. SNOWE. Madam President, I rise today to begin a discussion on the
prescription drug benefit and specifically the one that has been
introduced by the tripartisan group including Senator Grassley, Senator
Breaux, Senator Jeffords, Senator Hatch, and myself.
Before I proceed, I express my support for the amendment offered by
Senator Dorgan regarding reimportation. I have long supported that
initiative. Many of my seniors in the State of Maine have to travel
across the border into Canada in order to get prescription drugs that
are offered lower there than in the United States. It is a tragedy that
compels seniors to be put in a situation where they have to cross the
border in order to do that. I hope we can support that amendment so
they can have the benefit of those lower priced prescription drugs in
the United States. It is the only fair approach. It is one way of
addressing the issue of controlling costs and making costs competitive
so they can have the benefit of lower prices.
I am very pleased to talk about the tripartisan proposal. I regret we
have not had the opportunity in the Senate Finance Committee to be able
to consider competing proposals, certainly the one that has been
introduced by the ranking member, Senator Grassley, Senator Breaux,
Senator Jeffords, and Senator Hatch and myself, along with other
proposals, that obviously has the support of other members of the
committee.
We should do everything we can to have the opportunity to explore, to
debate, to consider the various proposals. Obviously, that starts
within the committee process. It is unfortunate at this point as we
begin to debate the other issues in the underlying bill, which is an
important piece of legislation, that we are not in a position of being
able to consider a prescription drug benefit plan. That is not the way
the process ought to work. If you look at what happened on the tax bill
last year, no one knew what the vote would be in the committee, let
alone on the floor, but we had the opportunity to address the issue
within the Senate Finance Committee. It ultimately passed 14 to 6.
When it came to the floor, it had 53 votes and ultimately yielded a
vote of 62 to 38. That is the way the process works. We did not write
the ending first. The prologue begins in the committee.
In this case, one of the most significant social domestic issues
facing this country today, prescription drug benefits, Medicare
authorization, and we have not been able to have a markup in the
committee of jurisdiction, the Senate Finance Committee, we are told,
because it does not have 60 votes. How many bills that are marked up in
the committee have 60 votes before they hit the floor of the Senate?
How do we know? How do we know until we begin the process of debating,
analyzing, considering various issues? That is what this process is all
about.
I truly regret we have not had the chance to be able to consider this
bill in the manner it deserves and in the manner it deserves for the
seniors of this country who are dealing with the overwhelming burden of
the high costs of prescriptions. Why are we allowing this to be
politicized? Why are we allowing this to be a matter of partisanship?
We have come a long way just on the funding issue alone. I have been
working on this issue in the Senate Budget Committee with then-Chairman
Domenici, Senator Wyden, Senator Smith, and others, and we were able to
develop a reserve fund. We started with $40 billion, which was more
than then-President Clinton had proposed. We are up to $300 billion,
and our tripartisan proposal is $370 billion, recognizing that as every
year passes, the price goes up and up. We have come a long way in even
understanding that we are going to have to spend more to provide a
strong benefit to seniors, and we must start now.
Some people might just want the issue for the next election. Maybe
that is what it is all about. Maybe some people want to see a headline
that says: Senate fails to muster the 60 votes; the issue is put off
for another year. I do not want to see that kind of headline. I do not
think it is fair to the seniors in this country because I know this
institution can do better, and that is why we put forward this
tripartisan proposal because we did not want partisan differences,
political differences, philosophical differences to impede our ability
to address this most important issue to the seniors in this country.
That is why we undertook this effort more than a year ago in our
tripartisan group to see what we could agree to that would provide a
most substantial benefit to the seniors in this country. Seniors cannot
put off their illnesses. We should not be putting off a solution, and
we crossed the political divide to develop our tripartisan proposal.
We worked closely with the Congressional Budget Office to ascertain
the precise cost of our proposal so we do not jeopardize the solvency
of the Medicare Program for future generations. We developed a
competitive, efficient model to yield the best results for seniors as
well as for the Government.
I do not want partisanship to jeopardize our ability to send a bill
to the President, Madam President. I want to break the logjam here and
now. Seniors have heard the excuses. How can we do anything less than
give this our full effort here and now, particularly for the one-third
of the Medicare beneficiaries who have no coverage whatsoever?
The Medicare Program is outdated, given the fact that it does not
include a prescription drug benefit first and foremost, and we need to
bring Medicare into the 21st century. The best way we can do it is by
adding a prescription drug benefit.
It is simply unconscionable in a country of our means and wealth that
older Americans should ever have to choose between filling their
cupboards and filling their prescriptions. That is not hyperbole; that
is not exaggeration; that is the truth. It certainly is the truth in my
State. People are forced to make those tragic choices, and we have
within our means right here and now, Madam President, to make the
difference so seniors are no longer forced to make that terrible
choice.
That is why we have offered the plan that we have. That is why I do
not want to bypass the committee, because I know that is our best
opportunity to pass a prescription drug benefit when we complete the
process that begins in the committee.
We should not have any political motivations or maneuvers to bypass
the process. I have been told: We cannot consider a bill in the
committee that does not have 60 votes. Since when has that been a
precondition for any markup in the committee? Then I am told: We cannot
have a bill that is not supported by the Democratic leadership. I never
thought that prevented us from doing our job; that eventually we could
reach results.
We are not saying our bill is written in concrete. We are saying this
is a beginning. It is a basis for action. Henry Ford used to tell his
Model T customers that they could have any color they wanted for a car
as long as it was black. It sort of reminds me of the situation we are
in today: We will consider a prescription drug bill as long as it is
ours.
[[Page S6891]]
We are saying let's bring out the proposals in the committee, let's
go through the committee process, and then let's report out a bill to
the floor. The tripartisan bill has the support of 12 members of the
committee as we speak--12 members of the 21. We have the support in the
committee, but let's go through the committee process. Let's do what we
need to do.
Refusing to have a markup in the Senate Finance Committee is hiding
behind false pretenses that we should only act if we have 60 votes.
Madam President, I want to discuss the tripartisan proposal and what
it is.
First and foremost, it is a plan that offers an affordable,
comprehensive, and available prescription drug benefit to seniors. It
maximizes the benefits for the low-income seniors, and finally, it is a
fully funded, permanent part of the Medicare process. There will be no
sunsets. Providing a sunset in legislation, as has been recommended by
the other competing plan offered by the Senator from Florida, is really
providing a false hope to seniors. How can we tell them: Oh, by the
way, in 7 years your benefit will expire? I think that is doing a
tremendous disservice to seniors in this country, saying we are only
willing to give this benefit for 7 years, so you had better not have an
illness because we are not going to be able to give you a benefit in 7
years.
Our plan is fully funded and a permanent part of Medicare. It has
been scored and estimated for cost by the Congressional Budget Office.
They have vetted every aspect of our proposal. It is right here in a
major legislative initiative. It is right here for everybody to review
and to evaluate.
The plan is universal. It is offered to every Medicare beneficiary.
That was a major priority for us, and it was a major priority for the
seniors in this country in all the discussions we had with seniors and
AARP. They wanted a universal, at the lowest possible monthly premium,
and that is exactly what our benefit provides. It is lower than any
other proposal that has been offered: A monthly premium of $24.
It will be offered to seniors whether they live in urban areas or
rural areas. They will have a choice of a minimum of two plans, no
matter where they live in America. The plan is targeted for seniors
between 135 percent and 150 percent of the poverty level. That is about
$18,000 for an elderly couple. They will receive coverage for about $12
a month at 150 percent of the poverty level. Below 135 percent they
will pay no premium, no deductible whatsoever.
The plan is comprehensive. They will have access to every drug,
whether it is a generic drug or the most advanced innovative therapies.
It also will provide relief from catastrophic costs from high annual
prescription drug costs.
Most of all, the plan will save the seniors real money, anywhere from
33 percent to 98 percent in out-of-pocket expenses, with the average
senior saving more than $1,600 every year, as my colleagues can see on
this chart. The average spending for seniors without any drug benefit
in 2005 will be $3,059 per year; more than a quarter of Medicare
beneficiaries spend more than $4,000.
The average savings under our proposal for seniors above 150 percent
of the poverty level will be more than 53 percent. For those below 135
percent, they will save 98 percent--98 percent--in their costs of
prescription drugs. But no matter, the average savings to seniors will
be at least one-half, more than $1,600.
Our plan eliminates the so-called donut for lower income seniors, the
seniors hardest hit by high drug costs. There are 11.7 million Medicare
beneficiaries who have incomes below 150 percent of the poverty level,
and they are exempt from the $3,450 benefit limit. The enrollees
between 135 percent and 150 percent of the poverty level will have a
monthly premium based on a sliding scale that ranges from anywhere from
zero to 24 percent.
The 10 million Medicare beneficiaries who have incomes below 135
percent of the poverty level will see, as I said, 98 percent of their
prescription drug costs covered by this plan with no monthly premium.
These seniors are exempt from the deductible and will pay an average
coinsurance of anywhere from $1 to $2 for prescription drugs.
They also have the protection of catastrophic limits, which will be
$3,700 under our legislation. That is where the catastrophic benefit
limit will begin, at $3,700. And they will have full protection against
all drug costs with no coinsurance.
All enrollees will have access to discounted prescription drugs after
reaching the $3,450 benefit limit and before the $3,700 catastrophic
benefit limit.
They will all still have access to discounted drugs between the
$3,450 and the $3,700 catastrophic benefit. In fact, 80 percent--let me
repeat, 80 percent--of the enrollees will never be affected by the
benefit limit of $3,450.
As you can see from this chart, I want to repeat, it has the lowest
premium of any of the comprehensive proposals that have been
introduced, at $24. Ninety-nine percent of Medicare beneficiaries,
according to CBO, will be participating under this program--99 percent.
Let me repeat, 99 percent.
The coinsurance paid for the top 50 drugs is $21. I want to compare
that to the proposal offered by the Senator from Florida, because under
the nonpreferred drug plan, of the top 50 drugs, we provide a lower
coinsurance on all but one. And for the top 50 drugs in the preferred
drug list, we provide a lower coinsurance than the proposal offered by
Senator Graham of Florida on all but 11 of the 50 drugs on the top 50
list.
So we are not only more substantial when it comes to providing the
coinsurance on all of these preferred and nonpreferred drugs--as you
see listed on the chart are the preferred drugs. For all but 11 out of
the 50 drugs, we are lower in our copays than the proposal offered by
Senator Graham of Florida. And for the nonpreferred drug list, we are
lower for all but 1 out of the 50 drugs. In other words, for 49 out of
the 50 we are lower. We provide a lower copay for these prescription
drugs, not to mention the fact that we provide a lower monthly premium
of $24 a month for those who are 150 percent above the poverty level.
For those that are below 135 percent of the poverty level, they pay
zero. And more importantly, our proposal is not sunsetted.
CBO estimated, as I said, that 99 percent of seniors will have
coverage under this proposal--99 percent of seniors. I think it is
important for everybody to understand that if we are going to offer a
prescription drug benefit, and if we are serious about making sure it
is part of the Medicare Program, then, clearly, it is important that we
make sure that it never expires, that we do not resort to budget
gimmicks or artificial sunset requirements that provide a false hope to
seniors.
Seniors deserve better than a false hope of a drug benefit that
expires after 7 years with no guarantee of further coverage. I think
that would be regretable if we decided to take that approach.
That is why we initiated this effort more than a year ago, to provide
a benefit that was generous, that would help the low incomes first and
foremost, that was universal, that was affordable, that did not
jeopardize the future financial stability of the Medicare Program--
because, obviously, that has to be the foremost concern to all of us as
well as to seniors--and that we had the maximum benefits possible for
seniors against high annual drug costs.
So I hope we will have the opportunity to have an honest, thorough
debate on a prescription drug benefit that can be included as a
permanent part of the Medicare Program.
Seniors are struggling under the burden of high prescription drug
costs. We cannot allow election year politics to overwhelm any chances,
any possibilities of getting a Medicare drug benefit through the Senate
this year. We must allow a full debate to occur on this issue both in
the committee and on the floor.
The Finance Committee should be a part of this process. Each of us
has a stake--individually and collectively--about the kind of process
we are willing to embrace in the Senate.
It does make a difference as to whether or not we are going to choose
to bypass the committees repeatedly and bring up significant
legislation on the floor without having the benefit of the committee
process and for those Members who serve on those respective committees
to be part of that process.
So each of us has a responsibility to that process, and, most
critically, when it comes to such an important issue to millions of
Americans: Those who are struggling under the weight of
[[Page S6892]]
high prescription drug costs and those who can expect to face the same
problem in the future.
I think each of us here knows that without a markup in the committee
we are creating a predetermined train wreck. We are heading for a train
wreck because we are creating a process designed for failure. It is
designed for politics. It is not designed for creating a solution to a
serious problem.
I think if we continue to resort to these ill-advised procedures and
political maneuvers and charades, and if we continue to allow this
political choreographing which sort of superficially addresses the
issue but does not really because we do not really want to create a
consensus and a compromise because we want the issue for this year's
elections, then we have failed and this Senate has abrogated its
responsibility to do what is right.
That is what it is all about. It is whether or not we choose to do
what is right. I think we all know what is right. Those of us in our
tripartisan group--I am not saying that our proposal, as I said
earlier, is written in stone. It is not a finite product, but it is a
serious product. It is one that has evolved for more than a year. It is
one that has been evaluated by the Congressional Budget Office. And it
is the only proposal that has been introduced that has bipartisan,
tripartisan support, and the only one that has been scored by the
Congressional Budget Office.
It is the only one that has the lowest monthly premium. And it is the
one that is not sunsetted. It is a permanent part of Medicare.
Getting back to this chart, seniors pay less for the top 50
prescriptions under the tripartisan plan versus the Graham-Kennedy-
Miller proposal. They pay less. So they pay less on their monthly
premium, and they pay less in their copays for the top 50
prescriptions, either on the preferred drug list or on the nonpreferred
drug list.
Those are the facts.
I just hope that we will have the opportunity to consider this
legislation and other competing proposals--such as the one offered by
the Senator from Florida, Senator Graham--in committee; utilizing the
committee process to amend, to debate and to vote on a final measure.
My proposal, as it stands, has the votes in the committee.
But let us go through the committee process. We would be more than
happy to evaluate other issues and other amendments of the members of
the committee.
I just do not understand why we can't have a markup in the Senate
Finance Committee. We are here to do our job. That is our
responsibility. That is why we have the committee process. I want to be
able to legislate the best solution to the problem. We have come up
with a proposal. Others have other proposals. But let us have a
competition of ideas and debate in the committee that allows for the
best hope for getting a bill through on the floor of the Senate that
will yield the 60 votes, that will go to conference, and the
differences worked out with the House.
As others have said, let us get a bill to the President for his
signature this year. I don't want another year to go by. That is what I
have been hearing every year. I have been hearing it every year now.
Four years ago, they said next year. Next year turns into 2 years, 4
years, 6 years. How long do we think seniors can wait for this
prescription drug benefit? How long? How long is it going to take? Why
is it that we have to have these political machinations? Our group--
Senator Grassley, Senator Breaux, Senator Jeffords, Senator Hatch--has
worked long and hard for more than a year. Why can't we have a markup
in the committee on this issue?
I would like to have a reasonable answer to that question. But I
don't think I am going to get a reasonable answer. There is nothing to
justify precluding us from doing our jobs in the committee. There is
nothing acceptable by what is happening here.
I am here to legislate. I don't expect everybody to agree with my
thoughts or my ideas or my proposals. But I do expect that we will
honor the process by which we have the ability to do our job.
Otherwise, we have all failed.
I don't care if it is a day before the election. I don't care. The
time is now. To be frank with all of you, I think that we should reach
the limits of our frustration with this process. Why do we continue to
say it is acceptable? The same machinations existed with the health
care proposal back in 1994. It is exactly the process it took. It
bypassed the committee process and came to the floor. Guess what.
Nothing happened.
Here we are in the year 2002--2002. We don't have a bill. The same is
going to happen with prescription drugs. People will say next year: We
can't do it.
We are getting paid to do our jobs now--not next year. We were
elected to do our job now. Senator Grassley has worked long and hard.
Senator Grassley, the ranking member of the Senate Finance Committee,
has gone the extra mile to reach out to both sides, to the chairman, to
other members of the committee, and to others here on the Senate floor
across the aisle, and as he did in this tripartisan proposal. Senator
Breaux and Senator Jeffords have also worked with us. We have been
working together because we know this is the only way we can accomplish
this most important issue for the seniors of this country.
I hope we will do the right thing. Let's begin this process in the
Finance Committee so that we can consider the proposals on the floor
which will ultimately yield the best results, not only in terms of
policy but for the seniors of this country.
I yield the floor.
The PRESIDING OFFICER (Mr. Reed of Rhode Island). The Senator from
Massachusetts.
Mr. KENNEDY. Mr. President, I intend to speak for a very few moments,
and then hopefully we will be on the amendment of the Senator from
North Carolina.
First of all, I thank my good friend, the Senator from Maine, for her
very eloquent and passionate speech and statement in favor of the
strong prescription drug program. It was eloquent, indeed. There were
parts of it that I agree with very much. There were some parts to which
I take exception. But I welcome the opportunity to have the kind of
discussion and debate that she eagerly awaits here in the Senate.
I agree with her that it is long overdue. I agree with her that the
time is now. I agree certainly with her that we are going to have to
find common ground. I hope very much that we can.
I respect those who have gone forward and supported the tripartisan
proposal.
Let me offer a few quick facts. Virtually none of the senior groups
are supporting the tripartisan program. That doesn't have to be the
bottom-line test. But they believe it doesn't provide the kind of
protections that are in the Graham-Miller legislation--I think that
they believe this for a very good reason. The tripartisan proposal has
an assets test that will exclude many of the neediest of our senior
citizens. The assets test says that if you have assets worth more than
$1,500, or a car worth more than $400, or personal property worth more
than $4,000, you are not eligible. That would affect a great many of
the people in my State.
I think it is also demeaning to seniors to have to go in and try to
give an assessment of what these personal items really are. I think we
will have a chance to debate that.
One of the very important aspects of the Graham bill is that it
doesn't have that test.
Second, there has been a good deal of talk about the estimated
premium of $24. That is just an estimate because this program is turned
over to the insurance companies. There is virtually no guarantee that
the premium is going to remain $24. It may be $34 or $44.
I find that senior citizens in my State want certainty, they want
predictability, they want to know exactly what that premium is going to
be now. That is something that we will have to debate.
Third, as the Congressional Budget Office indicated, it will mean
that 3.5 million seniors who are covered by their employer will be
dropped for a less adequate program because there is no reimbursement
for the employers.
That is not a finding that I make. It is a finding that the
Congressional Budget Office makes.
Finally, I want to make this point. The issue of prescription drugs
has been before the Finance Committee for 5 years. For 4 of the last 5
years, the Finance Committee has been under Republican control, and we
have had Republican leaders on the committee.
[[Page S6893]]
This is the first chance we have had to debate it.
I listened to the Senator talk about wanting an answer to why we are
not having a markup. I question why we didn't have one over the last 4
years. Now, under a Democratic leader, we are going to debate and
hopefully take action on the floor.
I don't think people in my State are wondering about the committee
process and how we are going to give adequate time for the committees
to work. They want the Senate to act. That is the commitment of our
leader. That is what they want.
I look forward to having the opportunity to act.
As the leader has pointed out, we want to try to deal with some of
the issues of accessibility and also cost containment. In that cost
containment debate, we have had strong bipartisan support in our
committee--now 16 to 5. We had five Republicans who worked very closely
on this issue.
We are going to find that there will be substantial savings for
seniors as a result. We are going to hopefully have the opportunity to
consider other amendments on this that are going to help deal with the
problems of the cost of prescription drugs. Then we will have an
opportunity to debate the other provisions.
But, as always, the Senator from Maine is eloquent, she is
passionate, and she is knowledgeable about these issues.
I am very hopeful that before the end of this debate we will be on
the same side in terms of supporting a program that will be worthy of
the people of Maine as well as Massachusetts.
The PRESIDING OFFICER. The Senator from New Hampshire.
Mr. GREGG. Mr. President, it is appropriate to address again the
issue of why this bill should have been vetted--not this bill we are
hearing about, the big bills that are coming at us, the drug bills for
drug benefits under Medicare--why they should have been vetted by the
Finance Committee.
The Senator from Massachusetts represents that it didn't happen the
last 5 years. There was no bill reported out of the committee. So why
should the committee have to take it up this year? Why not just write
it in the office of the majority leader, which is what has happened
here? We haven't seen the bill. It is ironic. We have had all the
representations as to what the Democratic bill is. We haven't even seen
the bill. It hasn't been scored. It doesn't exist, as far as we know.
Yet there are people out here puffing its strengths.
The reason you have to take this to committee is that if you don't
take it to committee, you guarantee, almost, that you will not pass a
bill. You are certainly not going to pass a bill that was drafted in
some back office around here. If the bill does not go through the
Finance Committee, it requires 60 votes to pass this body. It is
subject to a point of order under the Budget Act.
It appears that the reason Senator Grassley, being ranking member on
the Finance Committee, Senator Breaux, Senator Snowe, being members of
the Finance Committee, and Senator Hatch is supportive of this bill and
is a member of the committee--it appears within the Finance Committee
there is a working majority to pass a bill out, specifically the
tripartite bill. Senator Jeffords is a member of the committee who is
on this bill. There is a working majority to pass the bill out of the
committee right now. If that happens, when the bill comes to the floor,
it only needs 51 votes to pass and you actually get a drug benefit for
senior citizens.
The way this process has been set up by the Democratic leadership is
to create a hurdle that makes it virtually impossible to get a bill off
the floor of the Senate. That is the difference. That is why you need
to go through committee. The difference is that simple.
If you want to pass a bill, you go through the committee so you only
need 51 votes to pass it. If you don't want to pass a bill, don't take
it through the committee, because then you create a hurdle of 60 votes,
and it makes it virtually impossible to pass the bill.
This is a process which has been set up to fail, as has been
mentioned by innumerable speakers. It has been set up to fail. It has
been set up to create a political issue as we go into the August recess
before the November elections.
That is unfortunate. It is cynical. The Senator from Maine has, in
terms of considerable outrage, expressed her frustration with that type
of process. She has worked conscientiously with the Senators from Iowa
and Louisiana, and other Senators in this body, to develop what is a
consensus piece of legislation which will give seniors who are in dire
need of it a very significant benefit in the area of drugs, for
purchasing the drugs they need to live a decent life. It is a bill
which is fairly expensive. We are talking, I believe, about $400
billion. That is a lot of money. Maybe it is $350 billion over 10
years.
Whatever it is, it is a very expensive bill. We are talking about
taking a large amount of money from working Americans out of their
paycheck through taxes and using it to support a seniors drug benefit,
a very reasonable approach. Because it is such a large amount of money,
it is outside the budget which we presently have in place. We have a
$300 billion number which we put in place as a Congress last year to
try to address the drug issue to help seniors. The plan, bipartisanly
reached, tripartisanly reached, exceeds that number, as does every
other plan being proposed, except for the Hagel-Ensign plan which is
below that number.
All the other plans, with the exception of Hagel-Ensign, are subject
to a point of order and, thus, subject to 60 votes. And it is extremely
unlikely, considering the nature of the Senate, that you will get 60
votes for a final package. There are three different competing packages
on our side, and there is this phantom package on the other side being
written in an office, or a cloakroom, or a closet somewhere, and which
we will see someday.
In any event, we know it has not been adequately vetted and we know
the number is very high, over $600 billion minimum, maybe as high as $1
trillion if it is honestly scored.
That is why you have to go through committee. The committee has the
expertise on it. That is important. More importantly than that, the
committee gives the imprimatur of budgetary action, and if a bill is
reported out of the committee, it meets the budgetary guidelines; it is
not subject to a point of order.
So the misrepresentation that if it didn't happen the last 4 years
that the committee reported out a bill on this issue, why should the
committee have to report now, is a bit of a red herring. The issue
isn't that you didn't do it 4 years ago. The issue is, do you want to
pass a drug benefit package today or do you want a political issue? If
you want a political issue, don't run it through the committee, bring
it out on the floor and guarantee it fails because it can't get 60
votes. If you want a drug benefit package, put it through committee,
and the committee comes out with a package, which would probably be the
package outlined by Senator Snowe, and it gets 51 votes at least. I
suspect it will get more than 51--in the midfifties, probably.
Then you have a package with which you can turn to your senior
citizens and say: This will be a significant benefit to you as you deal
with the issue of prescription drugs. That is the difference. That is
why you need committee action on this bill. As long as there is no
committee action, I suspect you are guaranteeing failure.
The PRESIDING OFFICER. The Senator from Massachusetts.
Mr. KENNEDY. Mr. President, we will move on from here, but the fact
is, as the Senator stated correctly, if it were less than $300 billion,
then it would need 51 votes. But the Senator from Maine's proposal is
$370 billion. So they are going to need 60 votes, too. Do we
understand? I don't understand what the Senator from New Hampshire was
talking about. They are going to need 60 votes for their proposal
because they are going to violate the point of order.
When we are talking about the fact that the seniors are going to
spend, over 10 years, $1.8 trillion. With $300 billion you are going to
do very little to offset the kinds of challenges they are facing.
Finally, I have listened to our Republican leader, to my good friend
from New Hampshire about following the committees and how important it
is to follow the procedures. I am so thankful that we have a leader who
is bringing this to the floor of the Senate at last.
[[Page S6894]]
Now we hear this is circumventing procedure.
In May of 2000, Republicans brought S. 2557 to the floor, an energy
bill sponsored by Senator Lott, without committee approval; that was
the big energy bill. In March 2000, Republicans brought legislation to
the floor to eliminate the earnings test for individuals without
committee approval. I voted for that. I am glad they did it. In June of
1999, Republicans brought the Social Security lockbox to the floor
without committee approval. In July 1996, Republicans brought the
Taxpayer Bill of Rights.
It seems they were prepared to bring a lot of other things, but they
didn't bring a prescription drug bill to the floor. This leader has
said this is the priority and that is why we are having this debate
today.
I yield the floor.
The PRESIDING OFFICER. The Senator from North Dakota is recognized.
Mr. DORGAN. Mr. President, the amendment we are now considering, a
first- and second-degree amendment, I have offered for myself, Mr.
Wellstone, Mr. Jeffords, Ms. Stabenow, Ms. Collins, Mr. Levin, Mr.
Johnson, Mr. Miller, Mr. Durbin, Mr. Feingold, and Ms. Snowe. It is a
bipartisan amendment. It is a very important amendment--one that
addresses a part of that which we are here to consider on the floor of
the Senate on the issue of prescription drugs.
Let me describe what the problems are. One, we don't have a
prescription drug benefit in the Medicare Program, and we need to
change that. We need to add a prescription drug benefit to the Medicare
Program. Why do we need to do that? Because when Medicare was created,
many of the lifesaving miracle drugs that exist now that allow senior
citizens to live a longer and healthier life did not exist. So Medicare
was basically an opportunity to provide health insurance coverage for
doctors and hospitals but no prescription drug coverage. That was back
in the 1960s. Things have changed.
Were we to write a Medicare Program today, we would clearly include
prescription drug coverage in that Medicare Program. I mentioned senior
citizens especially because that is who benefits from the Medicare
Program. They represent about 12 percent of the population of our
country, and they consume one-third of all prescription drugs. It is
not unusual at all to talk to a senior citizen who has a series of
health issues, as they have reached the later stages of their lives,
and they have to take 4, 5, 10, and in some cases 12 different
prescription medicines every day in order to deal with their health
issues.
The problem is, when senior citizens reach that time of their lives
where they have retired and have a lower income, they have less ability
to be able to afford those prescription drugs. With the cost and
spending increasing substantially, senior citizens are finding all too
often that the prescription drugs they need to take are simply out of
reach.
Let me describe some of the consequences that result. I talked
yesterday about the woman who came up to me--and all of us have had
this experience--she grabbed me by the elbow and said: Senator Dorgan,
can you help me?
I said: What is wrong?
She said: Well, I have very serious health problems and my doctor
prescribed prescription drugs that I must take, but they are too
expensive. I don't have the money to be able to afford them.
Her eyes welled up with tears and her chin began to quiver and she
began to cry.
She said: Can you help me, please?
This happens all across the country every day. Let me just read some
letters. This is from a North Dakotan who wrote me some while ago,
about 2 months ago:
Dear Senator Dorgan: I just returned from a drug store,
where I happened to witness a very pathetic situation that
brought tears to my eyes. Standing in front of me at the
counter was an elderly gentleman about 80 years of age. He
handed 2 prescriptions to the pharmacist. He said, ``Before
you fill these, can you tell me what the price is?'' The
pharmacist checked the price through her computer and told
the elderly man, ``The first prescription is $94.76. The next
prescription is $49.88. Do you want me to fill them for
you?'' The old man looked around and was deep in thought and
said, ``No, I guess not. I haven't bought Christmas
presents for my wife and grandchildren. I will just put up
with the pain.'' Using his cane, he walked away.
``God bless America,'' she writes. ``I just thought,'' she said,
``you and your Senate colleagues who have reservations about the need
for lower priced prescription drugs ought to understand that this is
going on in our country.''
A North Dakotan wrote to me and said:
I am 86 years old, so I cannot work.
Her first thought, of course, would be to work.
I am 86 years old, so I cannot work. I am writing in regard
to the medication I take. I get $303 in Social Security every
month. I have never worked out of my home. I pay $400 a month
for my medication. I have had heart surgery and have
osteoporosis of the bones. The medicines are very high
priced. We need help. We are using all of our savings. I am
86 years old, so I cannot work.
Another woman from my State says:
I am a person with scleroderma, diagnosed at the Mayo 24
years ago. While this disease attacks different parts of my
body, it's mainly my lungs. I have been on oxygen for 2 years
now. A new medication is out named Tracleer. One pill a day
is $3,600 a year. I called Medicare to see if there was an
insurance I can buy for medications. I was told I could not
do that. I am a farm wife, 74 years old, who drove a tractor
until 2 years ago when I lost my husband and then my lungs
got worse.
She goes on at some great length.
I recall a snowy North Dakota day in January, in a small van going to
Canada with some senior citizens from my State. Among the people who
traveled to a little one-room drugstore in Emerson, Canada, that snowy
day was Silvia Miller, a 70-year-old Medicare beneficiary from Fargo,
ND, with no prescription drug coverage. She has diabetes, heart
problems, and emphysema. She takes 10 to 12 medications every day. In
1999, she spent more than $4,900 for her medications. Well, Silvia
Miller, like a lot of others, struggles to try to make do and deal with
very serious health problems and tries to catch an increased price
every year--increased costs of prescription drugs. Of course, she
cannot catch that. It is moving out of sight.
Last year, there was a 17- to 18-percent cost increase for
prescription drugs. The year before that, it was about 16 percent. The
year behalf that, it was about 17 percent. So year after year after
year, there are relentless increases in the cost of prescription drugs.
This trend continues. What can we do about it?
Well, the point we make with this amendment is this: We support fully
putting a prescription drug benefit in the Medicare Program. That ought
to be done. I hope it will be done. But if that is all we do--if we do
nothing to try to dampen down prices, put some downward pressure on
prescription drug prices, we will have done nothing but hook up a hose
to the Federal trough and we will suck it dry.
The American taxpayer beware. If we don't do something to try to put
some downward pressure on prescription drug prices, we cannot afford
putting a prescription drug benefit in the Medicare Program. We must do
both, in my judgment. Let's put the benefit in the Medicare Program,
make it optional, make it good, and at the same time let's do some
things that put downward pressure on prescription drug prices.
I mentioned that I went to Canada with a group of North Dakota senior
citizens. More recently, the Alliance For Retired Americans arranged 16
bus trips to Canada between May and June of this year to highlight the
enormous price differences that exist for the identical prescription
drugs between the United States and Canada. Participants in those 16
trips saved $506,000, or $1,340 per person.
I think it is important that we talk about policy in theory in the
U.S. Senate, but let me do something a bit more than that, if I can.
I ask unanimous consent to show some prescription drug bottles that
describe the real problem.
The PRESIDING OFFICER. Is there objection? Without objection, it is
so ordered.
Mr. DORGAN. Mr. President, if I might go through a few of these, it
will be useful for people to understand what senior citizens are
discovering with respect to pricing.
This prescription drug is Celebrex, quite a remarkable drug for pain.
It is sold both in the United States and Canada bottles that are
essentially identical. The U.S. consumer is charged
[[Page S6895]]
$2.22 per tablet. The Canadian consumer is charged 79 cents per tablet.
Same drug, same bottle, made by the same company; the difference is the
American consumer is charged dramatically more for the same
prescription drug.
Mr. President, Paxil is a prescription drug used to treat depression.
As you can see, these two pill bottles are identical. The cost is $2.22
per tablet to the U.S. consumer; for the Canadians, for the same drug,
it is 97 cents. Again, it is $2.22 for the American purchaser and 97
cents for the Canadian purchaser.
One might ask, as you go through this--and I have a couple more
examples--why the difference in pricing? Well, that is a good question.
We have had hearings on this and it is not that there is a difference
in the tablets in the bottles.
This is Zocor. A famous football coach talks about Zocor on
television every day. He says he takes this prescription drug and
recommends it to others who need it. Zocor is sold in the United States
in this bottle. It is $3.33 cents per tablet in the United States, and
it is $1.12 per tablet in Canada.
Finally, this is a prescription drug called Prevacid. As one can see,
this prescription drug, like the others, is marketed in an identical
bottle in the U.S. and Canada. This is used for ulcers. It has a label
that is of a slightly different color, but the bottle is identical--
same pill, same bottle, made by the same company. In the United States,
a purchaser pays $3.58 per tablet; in Canada, it is $1.26 per tablet. I
have more.
Mr. WELLSTONE. Will the Senator yield for a question?
Mr. DORGAN. I will be happy to yield.
Mr. WELLSTONE. What was the last drug?
Mr. DORGAN. Prevacid. It is used for ulcers.
Mr. WELLSTONE. May I add to the Senator's list two drugs? So much of
this is personal. I am sure he hears from people in North Dakota what I
hear from people in Minnesota, that this drives them crazy.
Permax is a drug to manage Parkinson's disease. The same bottle in
the United States is $398.24, and the Canadian price is $189. I mention
this because I ran into a teacher a couple months ago in my hometown
who, when I met him--I have not seen him for a while--I said: How are
you doing? We shook hands. I know Parkinson's. Both my parents had it.
I know it in the palm of my hand. I felt the shake. I said: Are you
taking Sinemet?
He said: Yes, but there is a better drug.
I said: Are you taking the other one?
He said: I cannot afford it.
This is by way of an example.
Did the Senator from North Dakota mention tamoxifen? It is a breast
cancer drug. The United States price, same bottle, is $287; Canadian
price, $24. I wanted to add two more examples to what my colleague
mentioned.
Mr. DORGAN. Tamoxifen is a good example because it is priced at 10
times the Canadian price for those in this country who need it to deal
with breast cancer. It is a good example.
This is a chart that shows other drugs, which I have not listed. It
shows the substantial changes in prices between the United States and
Canada.
Let me make a couple additional points.
I do not come here suggesting that the pharmaceutical manufacturing
industry or the manufacturers themselves are bad. I do not suggest they
are bad companies. In many cases, they do good work. They produce
lifesaving miracle drugs. I might say, they could from time to time
give more credit to the American taxpayer for some of that because a
substantial amount of research also goes on through the National
Institutes of Health that is federally funded, the benefits of which
then are used by the pharmaceutical manufacturers.
It is not my intention to tarnish those manufacturers as somehow
unworthy companies. It is my point to say that the pricing strategy
employed by those manufacturers is wrong and it penalizes the American
consumer.
They say: We must have this kind of pricing practice and pricing
strategy by which the American consumer pays the highest prices by far
because that is the way we get the money to do research and
development.
It is interesting that a report I read says they do slightly more
research and development in Europe than they do in the United States:
37 percent in Europe; 36 percent in the United States. And still in
virtually every country in Europe, they charge a much lower price for
the identical prescription drug they sell in the United States.
It is not the case that this is all about research and development.
The legislation we have introduced, the Prescription Drug Price Parity
for Americans Act, would allow U.S. consumers to benefit from the
international price competition for prescription medicines.
We have changed this approach from the previous legislation that was
enacted by the Congress because we make this apply only to the country
of Canada. We would like licensed and registered pharmacists and
distributors to be able to reimport into this country prescription
drugs that are approved by the FDA. We are limiting that to Canada
only. We will allow in this legislation pharmacists and distributors to
access FDA-approved drugs from Canada and bring them into this country
and pass the savings along to the American consumer.
This bill would become effective immediately. We have, as I said,
passed this legislation before. It has not been implemented by two
administrations because some have raised the question that this would
pose risks for the consumer. However, we have included provisions in
this legislation on page 9 addressing suspension of importation which
will minimize those risks.
While I talk about that for a moment, let me describe why I think
those risks are very minimal. Of course, we now have risks with respect
to the shipment of prescription drugs across borders. We ship a
substantial amount of United States manufactured drugs to Canada. In
fact, the Congressional Research Service has a report quoting an
information officer from Canada who says that most of the
pharmaceuticals marketed and distributed in Canada originate from U.S.
manufacturers.
The question we should ask, it seems to me, as policymakers, is, Why
should an American citizen have to go to Canada to get a fair price on
a prescription drug made in the United States? It is a rhetorical
question but I suspect one without an answer in this Chamber.
In any event, a substantial amount of the prescription drugs sold in
Canada are prescription drugs originating in the United States, and
there is now a law on the books that says the United States consumer,
through their pharmacists or through their licensed distributors, may
not access those drugs even if they are less costly in Canada. In my
judgment, that makes no sense at all.
Included in the legislation we have introduced is a provision that
would allow the Secretary of Health and Human Services to suspend
reimportation. Let me read the language we are including in the second-
degree amendment:
The Secretary shall require that importations of a specific
prescription drug or importations by a specific importer
under subsection (b) be immediately suspended on discovery of
a pattern of importation of the prescription drugs or by the
importer that is counterfeit or in violation of any
requirement under this section or poses an additional risk to
the public health until an investigation is completed and the
Secretary determines that the public is adequately protected
from counterfeit and violative prescription drugs being
imported under subsection (b).
David Kessler, former head of the FDA, had this to say in a letter to
us:
The Senate bill which allows only the importation of FDA-
approved drugs, manufactured in approved FDA facilities, for
which the chain of custody has been maintained, addresses my
fundamental concerns.
This is a larger description of his letter:
Let me address your specific questions. I believe U.S.
licensed pharmacists and wholesalers who know how drugs need
to be stored and handled and would be importing them under
the strict oversight of the FDA are well positioned to safely
import quality products rather than having American consumers
do this on their own.
The Congressional Research Service report I referred to a few moments
ago is a report that I had asked they complete in which they should
evaluate the chain of custody in Canada so we would understand whether
there is a chain of custody issue.
[[Page S6896]]
If we manufacture a prescription drug, for example, in the United
States and send it to end up on the shelf of a drugstore in Winnipeg,
Canada, is there a chain of custody problem that would allow someone to
say: You cannot have a pharmacist go to Winnipeg and buy that drug
because that is inherently unsafe?
The answer is no, that is just sheer nonsense that there is any kind
of a problem with that.
The CRS report says both countries have similar requirements and
processes for reviewing and approving pharmaceuticals, including
compliance with good manufacturing practices. We have similar rules for
requiring labeling. The Canadian Federal Government inspects drug
manufacturing facilities. Pharmacists and drug wholesalers have to be
licensed. There is no chain of custody question.
I understand one thing about this. If I were a pharmaceutical
manufacturer, I would want to kill this legislation. Why? Because the
pharmaceutical industry confronts price controls in some other
countries, and they do not like them. Those price controls allow them
to charge their costs and add a profit to it, and that is the price
they are able to exact.
There are no price controls in this country. So the pharmaceutical
manufacturers make the point that, if you can reimport prescription
drugs from somewhere else such as Canada, you are reimporting price
controls from Canada.
We have price controls in this country really. It is just that the
prescription drug manufacturers control the price, and they control the
price by charging the U.S. consumer the highest prices in the world.
Medicine after medicine, we find the U.S. consumers paying the highest
prices in the world.
Lifesaving prescription drugs save no lives if you cannot afford to
purchase them. Show me something else in the daily lives of the
American people, or especially of senior citizens, that they need--that
they don't have a choice on--that is increasing at 16, 17, 18 percent a
year. Can anyone come up with anything that relates to those kinds of
relentless increases? I do not think anyone can.
I want us to continue an aggressive search for miracle drugs and
lifesaving medicines. That is why many of us in this Chamber have
agreed to double the amount of funding at the National Institutes of
Health. This is the fifth and final year to do that. We have gone from
$12 billion to $24 billion. That was bipartisan. We did it. I want the
drug manufacturers as well to also engage in robust research and
development. I support research and development tax credits for that
purpose, from which they benefit. But I do not want the pharmaceutical
manufacturers to say to the American people: We have a scheme by which
we will impose upon you the highest prices of any group of people in
the world for our prescription drugs. We will have multitiered price
policies, and you, American citizens, shall pay the highest. We want
you to pay 10 times the cost for tamoxifen that our friends in
Winnipeg, Canada, are charged. We want you to pay substantially higher
prices for Zocor, Lipitor, Premarin, and Celebrex. It is simply not
fair.
The point of this amendment is not to try to force anyone to go to
Canada to buy prescription drugs. It is to try to force a repricing of
prescription drugs in this country, for if our registered pharmacists
and licensed distributors can access an FDA-approved drug in Canada and
bring it back and pass the savings along, it will certainly force a
repricing of prescription drugs in this country. That is my goal. That
is our goal.
So what we have today is an amendment that will allow the
reimportation, under very strict circumstances, of FDA approved
prescription drugs from Canada to the United States only by
licensed distributors and licensed pharmacists, and that will put
downward pressure on prescription drug prices.
What we also have in this Chamber, I think, are those who want to
kill this because the pharmaceutical industry does not like it. I
understand that. If I were the pharmaceutical industry, I would not
like it either. They have the best deal in the world in the United
States, but it is unfair to American consumers. It is unfair to those
in this country who need prescription drugs, who need lifesaving drugs,
who need these miracle drugs, and cannot afford them.
So even while we put a prescription drug benefit in the Medicare
plan, which I fully support, we must pass the underlying generic
amendment, which also has the effect of putting downward pressure on
prices.
We must pass this amendment, the reimportation amendment, which gives
very careful consideration to the safety issues that others have
raised, and we should not fear, and we should not shrink from, the
pharmaceutical manufacturers' attacks that somehow this is bad public
policy.
It is good public policy. They just do not like it. It is good public
policy for the American consumer, and it is safe for the American
consumer as well. My hope is that my colleagues will support this
amendment and I strongly urge them to do so.
The PRESIDING OFFICER. The Senator from Nevada.
Mr. REID. Mr. President, during the fine presentation of the Senator
from North Dakota, which is standard for the Senator from North Dakota,
I have been speaking with the managers of the bill. The other side
would accept his amendment by voice vote. I have not had a chance to
speak to the Senator from North Dakota, but it is my understanding that
he does want a recorded vote.
Mr. DORGAN. That is correct.
Mr. REID. May I ask the manager of the bill and Senator Cochran, who
is heavily involved in this, if we could set a time--we would draw
something up on paper--for a vote on this amendment at 2:30? I do not,
frankly, know if all the time would be taken up on this amendment. This
would give the Senator from Mississippi time, if he were so inclined,
to talk about his amendment. Part of the deal would be that the next
amendment in order would be the amendment of the Senator from
Mississippi, which will, of course, occur if this passes, and it
obviously is going to.
Mr. GREGG. As long as the position of the Senator from Mississippi is
protected as being the next amendment offered, I certainly have no
objection, but it is the call of the Senator from Mississippi.
Mr. COCHRAN. Mr. President, if the Senator will yield, I am happy to
recommend that to our side of the aisle. The only Senators I know of
who want to be heard on this amendment I will offer after the amendment
of Senator from North Dakota are Senator Breaux and Senator Roberts,
both of whom have expressed an interest in this amendment. I would like
the opportunity to see, though, if there are others who want to speak
and make sure we can accommodate everybody. But I personally do
not have any objection to a 2:30 vote.
Mr. REID. I say to my friend from Mississippi, I am sure his
amendment will take a little bit of time because he has people who want
to speak on it; the majority and others want to speak on it. We will
not set a time for dealing with his amendment.
Mr. COCHRAN. Good.
Mr. REID. If it gets out of hand, we can always move to table, but I
am sure the Senator from Mississippi, being one of the most experienced
legislators we have, understands the rules. We will try to be fair and
move this along as quickly as possible.
Mr. COCHRAN. Mr. President, I appreciate the assistance of the
distinguished Senator from Nevada. We will be glad to try to work with
him to accommodate that suggestion.
Mr. REID. What we will do is have the staffs prepare something on
paper, but generally we all understand what it would be; there would be
a vote on the Dorgan amendment at 2:30.
Mr. GREGG. With no intervening action?
Mr. REID. No intervening action. The person next to be recognized to
offer an amendment would be the Senator from Mississippi.
Mr. GREGG. With the time equally divided.
Mr. WELLSTONE. Mr. President, if I could say to the Senator from
Nevada, and I will relinquish the floor in a second, one of the things
we need to do on our side--I know Senator Stabenow wants to speak on
this. There are other Senators who also want to speak.
Mr. REID. That is why I set the time. We have until 2:30, and even
though
[[Page S6897]]
there is a conference, people can step out of that and speak. So we
will prepare something, and we should have it in the next few minutes.
The PRESIDING OFFICER. The Senator from Minnesota.
Mr. WELLSTONE. Before there is any unanimous consent agreement
propounded, I do want to make sure I state to my colleague from North
Dakota we have quite a few Senators who have worked on this for some
time and we want to make sure they do have a chance to come down.
I thank my colleague from North Dakota and my colleague from
Michigan, and all the other Senators on both sides of the aisle, who
support this legislation. I think this has been like about 5 years of
work, as I think back to when some of us first started this journey.
One of the things I want to do right away is deal with one of the
arguments that are made against this legislation. It is an argument by
the pharmaceutical companies that, look, we have to charge American
citizens a lot more because we need that money for the research.
Senator Stabenow was there, Senator Graham was there, as well as
Senator Miller.
One of the arguments we hear over and over again from the
pharmaceutical companies, the drug companies, is they need to make this
excessive amount of money, they need to have the very high priced drugs
because this goes to research for the miracle drugs that help everyone.
When the President was in Minneapolis in my State last week, he
adopted the pharmaceutical or the drug lobby's position and said that
the high prices everyone sees are necessary to sustain the research and
development.
One of the arguments made against this reimportation bill is, if you
begin to do that and people start getting discounts and we cannot
charge as much, we cannot put the money into the research. Families USA
came out with a report they called ``Profiting From Pain.'' They looked
at the drug company's recent submissions before the Securities and
Exchange Commission about their activities in 2001. They looked at the
nine publicly traded companies that market the top 50 drugs to seniors.
I will go over their key findings.
The first finding is these large pharmaceutical companies spent $45.4
billion on marketing and advertising and administration--this is from
their own SEC report--and $19 billion for research and development--
2\1/2\ times more for marketing, advertising, and administration as for
research and development.
The second finding for profits over the last 10 years, profits last
year as percentage of revenue, was 18.5 percent, 5.5 times the median
profit for the Fortune 500 companies.
The third key finding is these companies lavish huge compensation
packages and even larger stock options--does this sound familiar to
anyone--to the top drug executives. Mr. C.A. Heimbold, the former
chairman at Bristol-Myers, had the following compensation package, not
including unexercised stock options: Ready? $74.9 million; John R.
Stafford, chairman of Wyeth, $44.5 million. The five highest paid
executives received over $183 million last year.
Looking at the unexercised stock options, Mr. Raymond Gilmartin,
president and CEO of Merck, $93.3 million; Mr. C.A. Heimbold, $76.1
million; two Pfizer executives, $60.2 million and 56.5 million.
I make the plea in the Senate because pharmaceutical companies do not
want this bill. By the way, I said to my colleague from Michigan, who
has worked so hard on this, one of the reasons I love this legislation,
this helps all of our citizens, all our families. Pharmaceutical
companies and wholesalers can meet every strict FDA safety rule,
reimport back the prescription drugs and pass on the savings. That is
what this is about.
The drug industry should stop scaring citizens in our country,
seniors and others, with the false claim that if there is a discount
and people are charged a reasonable price, this will prevent research
in medicine. I thank Families USA for their excellent study. I make the
point which they made today, in light of the huge industry profits,
enormous executive compensation and big marketing budgets, these claims
that we need to rip people off with the obsessive, obscene profits in
order to do the research, are irresponsible and wrong.
The next point, by way of context of this amendment, it seems to me
the drug companies in this country are making Viagra-like profits--you
get the meaning of what I am saying--on the backs of American
consumers, on the backs of Minnesota consumers. The thought that these
companies, acting as a cartel, can make Viagra-like profits based on
the misery and illness and sickness of people is obscene.
We are going to do something about it and we are going to make sure
people in Minnesota and people around the country get a discount and
they get the same fair price that people in Canada get so people can
afford these prescriptions that are so important.
What does our amendment do? It allows for the reimportation of the
drugs from Canada. Believe me, many citizens from Michigan and
Minnesota and North Dakota know all too well what the differences are.
People can save as much as 40 percent, if not more, for their
prescription drugs. The amendment of Senator Dorgan, myself, Senator
Stabenow, and others would allow pharmacists, drug wholesalers, and
individuals to reimport safe and effective FDA-approved prescription
drugs from Canada. These drugs, developed in the United States, are
available in Canada for a fraction of the price of what we get charged.
This would help not only senior citizens but other Minnesotans and
other Americans as well.
Some examples to add to what my colleague from North Dakota
mentioned: Coumadin, blood thinner, same bottle, $20.99 in the United
States; Canadian price is $6.23. Zocor, a cholesterol drug, is $116.69
in the United States and $53.51 in Canada--same bottle, same
prescription. Permax, for Parkinson's disease, which so important to
people with that neurological disease, is $398.24 in the United States,
$189 in Canada. Tamoxifen, a breast cancer drug, is $287 in the United
States, $24.78 in Canada.
When I am traveling around Minnesota, people are asking me, more than
anything else, can't we get a discount? Isn't there something to do to
make the drugs affordable? A lot of Minnesotans ask why we can't have
the same price as our neighbors to the north. This is the best of free
trade and fair trade. Let our pharmacists and wholesalers meeting FDA
guidelines reimport these drugs back and pass on the savings to the
citizens we represent.
We have a provision for a suspension. If there is a problem with the
drug, the Secretary can stop the batch of drugs coming into the United
States until the investigation is completed.
Now we made it stronger, saying if there is any risk to public
health, any kind of risk at all to people in this country who deals
with public health where we have to worry about a batch of drugs that
should not be in here, that violates safety standard, then the
Secretary can stop the importation immediately. It is important to
protect the health of people. We do that. This language assures that
bad drugs are not going to reach patients in the United States and the
Secretary at that point in time can suspend those drugs.
What we cannot do, and what I want every Senator to be aware of, we
cannot let the pharmaceutical industry gut this amendment. We cannot
say that the Secretary of Health and Human Services, be it Democrat or
Republican, can set out conditions and certify those conditions have to
be met before we have the reimportation. If that is the case, we will
allow any Secretary of Health and Human Services in any administration
to kill this.
Our citizens are tired of being ripped off. They are tired of the
pharmaceutical companies running the show. Our people want a discount.
We move forward with this. If, God forbid, there is any tampering with
any drugs or any violation of public safety, then the Secretary of
State can immediately suspend. But we do not want to have any kind of
provision or any kind of amendment that passes that creates a huge
loophole that enables the pharmaceutical industry to do all their
behind the scenes lobbying and kill this legislation so that, in fact,
the Secretary of Health and Human Services never ends
[[Page S6898]]
up implementing it. That is not what the people in Minnesota are
asking. That is not what people in the country are asking.
Mr. REID. Mr. President, will my friend yield?
Mr. WELLSTONE. Yes.
Mr. REID. Mr. President, I ask unanimous consent that the time until
2:30 today be for debate on the pending amendments, with the time
equally divided and controlled between Senators Dorgan and Gregg or
their designees; that no intervening amendment be in order prior to the
disposition of amendment No. 4300; that a vote on or in relation to
amendment No. 4300 occur at 2:30 this afternoon, without further
intervening action or debate; provided further, upon disposition of
that amendment, Senator Cochran be recognized to offer an amendment on
the issue of drug reimportation.
The PRESIDING OFFICER (Mrs. Carnahan). Is there objection?
Without objection, it is so ordered.
The PRESIDING OFFICER. Under the previous order, the Senator from
Minnesota is recognized.
Mr. WELLSTONE. Madam President, I will take 1 more minute. Other
Senators want to speak. Senator Stabenow has been a leader on this
legislation for a long time and has been coordinating the effort of all
Democrats.
Let me just conclude this way: I know Senators do not want to be seen
as opposing an amendment that would enable all of our seniors and all
of our citizens to be able to get a reasonable price for prescription
drugs. My fear is that we will have an amendment out here with fine-
sounding language which will create a huge loophole and will basically
kill this amendment by giving any Secretary of Health and Human
Services the ability to stop this legislation before it is ever
implemented. That is unacceptable. That is unacceptable. We cannot let
the pharmaceutical industry kill this bill and kill this amendment.
I believe that people in Minnesota, people in Michigan, and people
around the country look at this as simple. I have said it before. I
will conclude it this way. I think this is a test case of whether we
have a system of democracy for the few or a democracy for the many. If
it is a democracy for the many, we will support this provision. If is
democracy for a few of the pharmaceutical companies, the devil is in
the details. They will be able to create a huge loophole, which will
mean this will never be implemented and they will be able to kill it.
I urge all colleagues to support this Dorgan, Wellstone, Stabenow, et
al, amendment and to resist any amendment to essentially gut this
amendment and stop this piece of legislation from being implemented.
I yield the floor.
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