I
107TH CONGRESS
1ST SESSION
H. R. 1862
To amend the Federal Food, Drug, and Cosmetic Act to provide greater
access to affordable pharmaceuticals.
IN THE HOUSE OF REPRESENTATIVES
MAY 16, 2001
Mr. BROWN of Ohio (for himself, Mrs. EMERSON, Mrs. THURMAN, Mr.
PALLONE, Mr. BALDACCI, Mr. STUPAK, Mr. SHOWS, Mr. ALLEN, Ms.
KAPTUR, Mr. SANDERS, and Mr. FRANK) introduced the following bill;
which was referred to the Committee on Energy and Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to
provide greater access to affordable pharmaceuticals.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Greater Access to Af-
fordable 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 in-
creasingly competitive during the last decade be-
cause of the increasing availability and accessibility
of generic pharmaceuticals, but competition must be
further stimulated and strengthened;
(4) the Federal Trade Commission has discov-
ered that there are increasing opportunities for drug
companies owning patents on brand-name drugs and
generic drug companies to enter into private finan-
cial 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 sci-
entific 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 pur-
chasers 
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 esti-
mated 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 com-
pared to brand-name pharmaceuticals has more than
doubled during the last decade, from approximately
19 percent to 43 percent, according to the Congres-
sional Budget Office;
(8) expanding access to generic pharmaceuticals
can help consumers, especially senior citizens and
the uninsured, have access to more affordable pre-
scription drugs;
(9) Congress should ensure that measures are
taken to effectuate the amendments made by the
Drug Price Competition and Patent Term Restora-
tion Act of 1984 (98 Stat. 1585) (referred to in this
section as the ‘‘Hatch-Waxman Act’’) to make ge-
neric 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 Cos-
metic 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. ACCELERATED GENERIC DRUG COMPETITION.
(a) IN GENERAL.—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)(iv), by striking sub-
clause (II) and inserting the following:
‘‘(II) the earlier of—
‘‘(aa) the date of a final decision of a
court in an action described in clause (iii)
(from which no appeal can or has been
taken); or
‘‘(bb) the date of a settlement order
or consent decree signed by a Federal
judge that enters a final judgment and in-
cludes a finding that the patents that are
the subject of the certification are invalid
or not infringed;’’;
(2) by redesignating subparagraphs (C) and
(D) as subparagraphs (E) and (F), respectively; and
(3) by inserting after subparagraph (B) the fol-
lowing:
‘‘(C) FORFEITURE OF 180-DAY PERIOD.—
‘‘(i) IN GENERAL.—The 180-day pe-
riod described in subparagraph (B)(iv)
shall be forfeited by the previous applicant
and become available to the next applicant
submitting an application containing a cer-
tification 
described 
in 
paragraph
(2)(A)(vii)(IV) if—
‘‘(I) the previous applicant fails
to market the drug within 90 days
after the date on which the approval
of the application for the drug is
made effective under subparagraph
(B)(iii);
‘‘(II) the previous applicant with-
draws the application;
‘‘(III) the previous applicant
amends the certification from a cer-
tification under subclause (IV) to a
certification 
under 
paragraph
(2)(A)(vii)(III), either voluntarily or
as a result of a settlement or defeat in
patent litigation;
‘‘(IV) the previous applicant fails
to get tentative approval of the appli-
cation within 30 months after the
date on which the application is filed,
unless the failure is caused by—
‘‘(aa) a change in the re-
quirements for tentative approval
of the application imposed after
the date on which the application
was filed; or
‘‘(bb) other extraordinary or
unusual circumstances, as deter-
mined by the Secretary;
‘‘(V) in a case in which, after the
date on which the previous application
was submitted under this subsection,
new patent information is submitted
for the drug under subsection (c)(2)
for a patent for which certification is
required 
under 
paragraph
(2)(A)(vii)(IV), the previous applicant
fails to challenge the patent that is
the subject of the information within
60 days after the date on which the
patent information is submitted; or
‘‘(VI) the previous applicant is
determined by the Secretary, after a
fair and sufficient hearing and in con-
sultation with the Federal Trade
Commission, to have engaged in anti-
competitive or collusive conduct, or
any other conduct intended to unfairly
monopolize the commercial manufac-
turing of the drug of the application.
‘‘(ii) AVAILABILITY.—The 180-day pe-
riod described in subparagraph (B)(iv)
shall be available only to—
‘‘(I) the previous applicant sub-
mitting an application for a drug
under this subsection containing a
certification described in paragraph
(2)(A)(vii)(IV) with respect to any
patent; or
‘‘(II) under clause (i), the next
applicant submitting an application
for a drug under this subsection con-
taining such a certification with re-
spect to any patent;
even if an application has been submitted
for the drug under this subsection con-
taining such a certification with respect to
a different patent.
‘‘(iii) APPLICABILITY.—The 180-day
period described in subparagraph (B)(iv)
shall apply only if—
‘‘(I) the application contains a
certification described in paragraph
(2)(A)(vii)(IV); and
‘‘(II) an action is brought for in-
fringement of a patent that is the
subject of the certification or the ap-
plicant brings an action (not later
than 50 days after the date on which
the notice provided under paragraph
(2)(B)(ii) was received), against the
holder of the approved application for
the listed drug.’’.
(b) EFFECTIVE DATE.—The amendment made by
this section shall be effective only with respect to an appli-
cation filed under section 505(j) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(j)) 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.
SEC. 4. BIOEQUIVALENCE TESTING METHODS.
Section 505(j)(8)(B) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(8)(B)) is amended—
(1) in clause (i), by striking ‘‘or’’ at the end;
(2) in clause (ii), by striking the period at the
end and inserting ‘‘; or’’; and
(3) by adding at the end the following:
‘‘(iii)(I) clauses (i) and (ii) are not applica-
ble, as determined by the Secretary;
‘‘(II) the effects of the drug and the listed
drug do not show a significant difference based
on tests (other than tests that assess rate and
extent of absorption), including—
‘‘(aa) a bioequivalence study with a
pharmacodynamic endpoint;
‘‘(bb) a bioequivalence study with a
clinical endpoint;
‘‘(cc) in vitro methods; or
‘‘(dd) any other methodology that
demonstrates that no significant dif-
ferences in therapeutic effects of active in-
gredients are expected; and
‘‘(III) limited confirmatory studies to sup-
plement the bioequivalence testing are consid-
ered necessary by the Secretary.’’.
SEC. 5. CITIZEN PETITIONS.
Section 505(j)(5) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(5)) (as amended by sec-
tion 3(a)) is amended by inserting after subparagraph (C)
the following:
‘‘(D) CITIZEN PETITIONS.—
United States Code, shall apply to a per-
son that submits a petition under section
10.30 of title 21, Code of Federal Regula-
tions (or any successor regulation).
‘‘(iii) INVESTIGATIONS.—
‘‘(I) IN GENERAL.—The Federal
Trade Commission shall investigate,
on receipt of a complaint or upon its
own initiative, any petition submitted
under section 10.30 of title 21, Code
of Federal Regulations (or any suc-
cessor regulation), that may have been
submitted for an improper purpose,
such as to delay competition or agen-
cy action.
‘‘(II) REFERRAL.—If the Com-
mission finds that a petitioner has en-
gaged in conduct that may be illegal,
the Commission shall refer the peti-
tion to the Antitrust Division of the
Department of Justice for further ac-
tion.
‘‘(iv) NOTICE OF RECEIPT OF CONSID-
ERATION.—
‘‘(I) IN
GENERAL.—A person
that submits a petition under section
10.30 of title 21, Code of Federal
Regulations (or any successor regula-
tion), shall provide a written notice to
the Federal Trade Commission if the
person receives any consideration for
submitting the petition.
‘‘(II) A notice under subclause
(I) shall include—
‘‘(aa) the name of the per-
son or entity that provided the
consideration;
‘‘(bb) the dollar value of the
consideration, if provided in cash,
or a description of such consider-
ation;
‘‘(cc) the date on which the
consideration was provided; and
‘‘(dd) any other information
that the Commission requires to
be disclosed.’’.
SEC. 6. PATENT CERTIFICATION.
(a) ABBREVIATED NEW DRUG APPLICATIONS.—Sec-
tion 505(j)(5) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(j)(5)) (as amended by section 3(a)(2))
is amended—
(1) in subparagraph (B), by striking clause (iii)
and inserting the following:
‘‘(iii) CERTIFICATION
THAT
PATENT
IS INVALID OR WILL NOT BE INFRINGED.—
‘‘(I) IN
GENERAL.—Except as
provided in subclauses (II) and (III),
if the applicant made a certification
described 
in 
paragraph
(2)(A)(vii)(IV), the approval shall be
made effective on the expiration of 45
days after the date on which the no-
tice 
provided 
under 
paragraph
(2)(B)(ii) was received.
‘‘(II) ACTION
FOR
PATENT
IN-
FRINGEMENT.—If 
an 
action 
is
brought for infringement of a patent
that is the subject of the certification
before the expiration of the 45-day pe-
riod beginning on the date on which
the notice provided under paragraph
(2)(B)(ii) was received, the approval
shall be made effective on the expira-
tion of the 45-day period unless the
court grants a preliminary injunction
prohibiting the applicant from engag-
ing in the commercial manufacture or
sale of the drug until the court de-
cides the issues of patent validity and
infringement.
‘‘(III) PATENT INVALID OR NOT
INFRINGED.—If the court decides that
the patent is invalid or was not in-
fringed, the approval shall be made ef-
fective on the date of the court deci-
sion.
‘‘(IV) PATENT
INFRINGED.—If
the court decides that the patent was
infringed, the approval shall be made
effective on such date as the court or-
ders under section 271(e)(4)(A) of
title 35, United States Code.
‘‘(V) PROCEDURE.—In an action
described in subclause (II)—
‘‘(aa) each of the parties
shall reasonably cooperate in ex-
pediting the action;
‘‘(bb) until the expiration of
45 days after the date the notice
provided 
under 
paragraph
(2)(B)(i) was received, no civil
action may be brought under sec-
tion 2201 of title 28, United
States Code, for a declaratory
judgment with respect to the pat-
ent, except as provided in sub-
paragraph (H); and
‘‘(cc) any such civil action
shall be brought in the judicial
district in which the defendant
has its principal place of business
or a regular and established place
of business.’’; and
(2) by adding at the end the following:
‘‘(G) CIVIL
ACTION
FOR
DECLARATORY
JUDGMENT.—A person that files an abbreviated
application for a new drug under this para-
graph may bring a civil action against the hold-
er of an approved application for a listed drug
for a declaratory judgment to determine wheth-
er the patent that claims the listed drug or a
method of using the drug is invalid or will not
be infringed.
‘‘(H) CIVIL ACTION TO DETERMINE LEGAL
STATUS.—Notwithstanding any other provision
of law, if information on a patent for a listed
drug has been published under subsection (c)(2)
for at least 1 year after the date on which an
abbreviated application for approval of a new
drug was filed under this subsection in relation
to the listed drug, the person that filed the ab-
breviated application or the holder of the ap-
proved application for the listed drug may im-
mediately bring a civil action to determine the
legal status of the patent for the listed drug.’’.
(b) NEW DRUG APPLICATIONS.—Section 505(c)(3)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(c)(3)) is amended by striking subparagraph (C) and
inserting the following:
‘‘(C) CERTIFICATION THAT PATENT IS IN-
VALID OR WILL NOT BE INFRINGED.—
‘‘(i) IN
GENERAL.—Except as pro-
vided in clauses (ii) and (iii), if the appli-
cant made a certification described in sub-
section (b)(2)(A)(iv), the approval shall be
made effective on the expiration of 45 days
after the date on which the notice provided
under subsection (b)(3)(B) was received.