I 
109TH CONGRESS 
2D SESSION 
H. R. 6022 
To amend the Federal Food, Drug, and Cosmetic Act with respect to market 
exclusivity for certain drugs, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 28, 2006 
Mr. WAXMAN (for himself, Mr. PALLONE, and Ms. DELAURO) 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 with 
respect to market exclusivity for certain drugs, and for 
other purposes. 
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 ‘‘Lower Prices Reduced 
with Increased Competition and Efficient Development of 
Drugs Act’’ or the ‘‘Lower PRICED Drugs Act’’. 
SEC. 2. GENERIC DRUG USE CERTIFICATION. 
(a) IN GENERAL.—Section 505(j)(2)(A) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
355(j)(2)(A)) is amended— 
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(1) in clause (vii), by striking ‘‘; and’’ and in-
serting a semicolon; 
(2) in clause (viii), by striking the period and 
inserting ‘‘; and’’; 
(3) by inserting after clause (viii) the following: 
‘‘(ix) if with respect to a listed drug product re-
ferred to in clause (i) that contains an antibiotic 
drug and the antibiotic drug was the subject of any 
application for marketing received by the Secretary 
under section 507 (as in effect before the date of the 
enactment of the Food and Drug Administration 
Modernization Act of 1997) before November 20, 
1997, the approved labeling includes a method of 
use which, in the opinion of the applicant, is claimed 
by any patent, a statement that— 
‘‘(I) identifies the relevant patent and the 
approved use covered by the patent; and 
‘‘(II) the applicant is not seeking approval 
of such use under this subsection.’’; and 
(4) in the last sentence, by striking ‘‘clauses (i) 
through (viii)’’ and inserting ‘‘clauses (i) through 
(ix)’’. 
(b) EFFECTIVE DATE.—The amendments made by 
this section apply to any abbreviated new drug application 
under section 505(j) of the Federal Food, Drug, and Cos-
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metic Act (21 U.S.C. 355(j)) that is submitted on, before, 
or after the date of the enactment of this Act. 
SEC. 3. PREVENTING ABUSE OF THE THIRTY-MONTH STAY- 
OF-EFFECTIVENESS PERIOD. 
(a) IN GENERAL.—Section 505(j)(5)(B)(iii) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(j)(5)(B)(iii)) is amended— 
(1) in the second sentence by striking ‘‘may 
order’’ and inserting ‘‘shall order’’; and 
(2) by adding at the end the following: ‘‘In de-
termining whether to shorten the thirty-month pe-
riod under this clause, the court shall consider the 
totality of the circumstances, including whether the 
plaintiff sought to extend the discovery schedule, de-
layed producing discovery, or otherwise acted in a 
dilatory manner, and the public interest.’’. 
(b) EFFECTIVE DATE.—The amendments made by 
this section apply to any stay of effectiveness period under 
section 505(j)(5)(B)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iii)) pending or 
filed on or after the date of the enactment of this Act. 
SEC. 4. ENSURING PROPER USE OF PEDIATRIC EXCLU-
SIVITY. 
(a) IN GENERAL.—Section 505A of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is 
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amended by striking subsections (b) and (c) and inserting 
the following: 
‘‘(b) MARKET EXCLUSIVITY FOR NEW DRUGS.— 
‘‘(1) IN GENERAL.—With respect to a pending 
application under section 505(b)(1), each of the pe-
riods of time under this chapter specified in para-
graph (2) that is applicable with respect to the drug 
involved is deemed to be extended by the period of 
time determined under subsection (d) if, prior to ap-
proval of such application— 
‘‘(A) the Secretary determines that infor-
mation relating to the use in the pediatric pop-
ulation of the drug may produce health benefits 
in that population; 
‘‘(B) the Secretary makes a written re-
quest to the sponsor of the application for one 
or more pediatric studies, which request shall 
include a timeframe for completing such stud-
ies; 
‘‘(C) the sponsor agrees to the request; 
‘‘(D) such studies are completed within 
any such timeframe and the reports thereof 
submitted in accordance with subsection (e)(2) 
or accepted in accordance with subsection 
(e)(3); and 
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‘‘(E) based on the results of such studies, 
the Secretary approves labeling for the drug or 
drug product that provides specific, therapeuti-
cally meaningful information about the use of 
the drug in pediatric patients. 
‘‘(2) PERIOD OF TIME TO BE EXTENDED.—For 
purposes of paragraph (1), the periods of time under 
this chapter that are specified in this paragraph 
with respect to the drug involved are the following: 
‘‘(A) In section 505: 
‘‘(i) 
In 
each 
of 
subsections 
(c)(3)(E)(ii) and (j)(5)(F)(ii): 
‘‘(I) The period of five years. 
‘‘(II) The period of four years, 
the period of forty-eight months, and 
the period of seven and one-half years. 
‘‘(ii) In each of clauses (iii) and (iv) 
of subsection (c)(3)(E), and in each of 
clauses 
(iii) 
and 
(iv) 
of 
subsection 
(j)(5)(F), the period of three years. 
‘‘(B) In section 527(a), the period of seven 
years, in the case of a drug designated under 
section 526 for a rare disease or condition. 
‘‘(C) In section 505, under subsections 
(c)(3) and (j)(5)(B), the period of time during 
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which the approval of an application may not be 
made effective, in the case of a drug that— 
‘‘(i) is the subject of a qualifying list-
ed patent for which a certification has been 
submitted under subsection (b)(2)(A)(ii) or 
(j)(2)(A)(vii)(II) of such section and for 
which pediatric studies were submitted 
prior to the expiration of the patent (in-
cluding any patent extensions); 
‘‘(ii) is the subject of a qualifying list-
ed patent for which a certification has been 
submitted under subsections (b)(2)(A)(iii) 
or (j)(2)(A)(vii)(III) of such section; or 
‘‘(iii) is the subject of a qualifying 
listed patent for which a certification has 
been 
submitted 
under 
subsection 
(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of such 
section, and with respect to which, in the 
patent infringement litigation resulting 
from the certification, the court determines 
that the patent is valid and would be in-
fringed. 
With respect to subparagraph (C), the extension of 
time that applies under this subsection begins on the 
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day after the date of the expiration of the patent in-
volved (including any patent extension). 
‘‘(3) QUALIFYING LISTED PATENT.—With re-
spect to a study submitted pursuant to paragraph 
(1), a patent concerning a drug is a qualifying listed 
patent for purposes of this subsection if the patent 
meets the condition described in subparagraph (A), 
or the condition described in subparagraph (B), as 
follows: 
‘‘(A) Information on the patent had been 
filed with the Secretary as required under sub-
section (b)(1) or (c)(2) of section 505 as of the 
date on which the study was submitted to the 
Secretary pursuant to paragraph (1). 
‘‘(B) After such date, the patent became 
subject to the requirement under such sub-
section to file information on the patent as a re-
sult of the approval by the Secretary of a use 
of the drug in the pediatric population, which 
use— 
‘‘(i) is described in the approved label-
ing referred to in paragraph (1)(D); and 
‘‘(ii) is claimed by the patent. 
‘‘(c) MARKET EXCLUSIVITY
FOR ALREADY-MAR-
KETED DRUGS.— 
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‘‘(1) IN
GENERAL.—With respect to an ap-
proved application under section 505(b)(1), each of 
the periods of time under this chapter specified in 
paragraph (2) that is applicable with respect to the 
drug involved is deemed to be extended by the period 
of time determined under subsection (d) if— 
‘‘(A) the Secretary determines that infor-
mation relating to the use in the pediatric pop-
ulation of the drug may produce health benefits 
in that population; 
‘‘(B) the Secretary makes a written re-
quest to the holder of such application for one 
or more pediatric studies, which request shall 
include a timeframe for completing such stud-
ies; 
‘‘(C) the holder agrees to the request; 
‘‘(D) such studies are completed within 
any such timeframe and the reports thereof 
submitted in accordance with subsection (e)(2) 
or accepted in accordance with subsection 
(e)(3); and 
‘‘(E) based on the results of such studies, 
the Secretary approves labeling for the drug 
that provides specific, therapeutically meaning-
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ful information about the use of the drug in pe-
diatric patients. 
‘‘(2) PERIOD OF TIME TO BE EXTENDED.—For 
purposes of paragraph (1), the periods of time under 
this chapter that are specified in this paragraph are 
the periods of time referred to in subsection (b)(2), 
as applied to the drug referred to in paragraph (1). 
With respect to periods of time referred to in sub-
section (b)(2)(C) as applied to such drug, the exten-
sion of time that applies under this subsection be-
gins on the day after the date of the expiration of 
the patent involved (including any patent extension). 
‘‘(3) QUALIFYING LISTED PATENT.—With re-
spect to a study submitted pursuant to paragraph 
(1), a patent concerning a drug is a qualifying listed 
patent for purposes of this subsection if the patent 
meets one of the conditions described in subpara-
graph (A) or (B) of subsection (b)(3), as applied to 
the drug referred to in paragraph (1).’’. 
(b) DETERMINATION OF EXTENSION PERIOD.—Sec-
tion 505A of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355a) is amended— 
(1) by redesignating subsections (d) through 
(n) as subsections (e) through (o), respectively; and 
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(2) by inserting after subsection (c) the fol-
lowing: 
‘‘(d) DETERMINATION OF EXTENSION PERIOD.— 
‘‘(1) IN
GENERAL.—For purposes of sub-
sections (b) and (c), the extension period determined 
under this subsection with respect to a drug is the 
following, as applicable: 
‘‘(A) One month, if the sales revenue for 
the drug that is projected under paragraph (3) 
for the base year is $1,000,000,000 or more. 
‘‘(B) Two months, if the sales revenue for 
the drug that is so projected is $500,000,000 or 
more but less than $1,000,000,000. 
‘‘(C) Three months, if the sales revenue for 
the drug that is so projected is less than 
$500,000,000. 
‘‘(2) BASE YEAR.—For purposes of this sub-
section, the base year for a drug is the calendar year 
during which market exclusivity under Federal law 
for the drug would expire in the absence of an exten-
sion under subsection (b) or (c). 
‘‘(3) PROJECTION OF SALES REVENUE.— 
‘‘(A) IN GENERAL.—For purposes of para-
graph (1), the Secretary shall make an estimate 
of the sales revenue for a drug for a base year 
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on the basis of the sales histories of an appro-
priate sample of drugs over the 20-year period 
preceding the date of the enactment of the 
Lower PRICED Drugs Act, including data on 
the sales revenue of the drug that has been in-
cluded in reports by IMS Health. 
‘‘(B) TIMING
OF
PROJECTION.—An esti-
mate under subparagraph (A) for a drug shall 
be a projection made in advance of the base 
year for the drug. In the case of an extension 
period under subsection (b), the projection may 
not be made earlier than the expiration of the 
two-year period beginning on the date on which 
the drug is approved by the Secretary under 
section 505, unless all market exclusivity under 
Federal law for the drug will, in the absence of 
an extension under subsection (b), expire before 
the expiration of such period, in which case the 
projection shall be determined not later than 
three months before the beginning of the base 
year. 
‘‘(C) IMS HEALTH.—The reference in sub-
paragraph (A)(ii) to IMS Health is a reference 
to the corporation Intercontinental Marketing 
Services, first established in 1954, whose activi-
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