I
105TH CONGRESS
1ST SESSION
H. R. 1727
To amend the Federal Food, Drug, and Cosmetic Act to allow for additional
deferred effective dates for approval of applications under the new drugs
provisions, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
MAY 22, 1997
Mr. GREENWOOD (for himself, Mr. WAXMAN, Mr. BURR of North Carolina,
Mr. UPTON, Mrs. JOHNSON of Connecticut, Mr. KLUG, Mr. FRANKS of
New Jersey, Ms. LOFGREN, Ms. PRYCE of Ohio, Mr. TOWNS, Ms.
DEGETTE, Mr. BOUCHER, Mr. FALEOMAVAEGA, Mr. HORN, and Ms.
SLAUGHTER) introduced the following bill; which was referred to the
Committee on Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to
allow for additional deferred effective dates for approval
of applications under the new drugs provisions, 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 ‘‘Better Pharma-
ceuticals for Children Act’’.
SEC. 2. FINDINGS.
Congress finds that—
(1) children are the future of the Nation and
the preservation and improvement of child health is
in the national interest;
(2) the preservation and improvement of child
health may require the use of pharmaceutical prod-
ucts;
(3) children may metabolize drugs differently
from adults and may require smaller doses or dif-
ferent forms of administration of the drugs;
(4) the testing of drugs for safety and
pharmacokinetics is necessary to ensure that the
drugs are safe and effective for use by children;
(5) it is estimated that 4 out of 5 drugs on the
market in the United States have not been approved
for use by children;
(6) many other drugs are not manufactured in
a form that permits young children to use such
drugs and consequently untested and unapproved
forms are often employed;
(7) many of these drugs are nonetheless widely
used by children or hold promise for use by children,
despite the lack of approval, dosage, labeling, or for-
mulation;
thus are not candidates for protection under this
Act;
(13) if this Act is enacted, the PPRU Network
will continue to be well suited to continue to use
public funds and such private funds as may be avail-
able to conduct research on such drugs for pediatric
use; and
(14) if this Act is enacted, the safety and effec-
tiveness of the use of pharmaceuticals by children
will be improved and the health of the children of
this Nation will benefit.
SEC. 3. PEDIATRIC STUDIES MARKETING EXCLUSIVITY.
Chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.) is amended by inserting after
section 505 the following new section:
‘‘SEC. 505A. PEDIATRIC STUDIES OF DRUGS.
‘‘(a) MARKET EXCLUSIVITY FOR NEW DRUGS.—If,
prior to approval of an application that is submitted under
section 505(b)(1) the Secretary determines that informa-
tion relating to the use of a drug in the pediatric popu-
lation may produce health benefits in that population, the
Secretary makes a written request for pediatric studies
(which may include a time frame for completing such stud-
ies), and such studies are completed within any such time
frame and the reports thereof submitted in accordance
with subsection (d)(2) or completed within any such time
frame and the reports thereof are accepted in accordance
with subsection (d)(3)—
‘‘(1)(A) the period during which an application
may 
not 
be 
submitted 
under 
subsections
(c)(3)(D)(ii) and (j)(4)(D)(ii) of section 505 shall be
five years and six months rather than five years, and
the references in subsections (c)(3)(D)(ii) and
(j)(4)(D)(ii) of section 505 to four years, to forty-
eight months, and to seven and one-half years shall
be deemed to be four and one-half years, fifty-four
months, and eight years, respectively; or
‘‘(B) the period of market exclusivity under
subsections (c)(3)(D) (iii) and (iv) and (j)(4)(D) (iii)
and (iv) of section 505 shall be three years and six
months rather than three years; and
‘‘(2)(A) if the drug is the subject of—
‘‘(i) a listed patent for which a certification
has 
been 
submitted 
under 
section
505(b)(2)(A)(ii) or section (j)(2)(A)(vii)(II) and
for which pediatric studies were submitted prior
to the expiration of the patent (including any
patent extensions), or
‘‘(ii) a listed patent for which a certifi-
cation has been submitted under section
505(b)(2)(A)(iii) 
or 
section
505(j)(2)(A)(vii)(III),
the period during which an application may not be
approved 
under 
section 
505(c)(3) 
or 
section
505(j)(4)(B) shall be extended by a period of six
months after the date the patent expires (including
any patent extensions); or
‘‘(B) if the drug is the subject of a listed patent
for which a certification has been submitted under
section 
505(b)(2)(A)(iv) 
or 
section
505(j)(2)(A)(vii)(IV), and in the patent infringement
litigation resulting from the certification the court
determines that the patent is valid and would be in-
fringed, the period during which an application may
not be approved under section 505(c)(3) or section
505(j)(4)(B) shall be extended by a period of six
months after the date the patent expires (including
any patent extensions).
‘‘(b) SECRETARY TO DEVELOP LIST OF DRUGS FOR
WHICH ADDITIONAL PEDIATRIC INFORMATION MAY BE
BENEFICIAL.—Not later than 180 days after the date of
enactment of this section, the Secretary, after consultation
with experts in pediatric research (such as the American
Academy of Pediatrics, the Pediatric Pharmacology Re-
search Unit Network, and the United States Pharma-
copoeia) shall develop, prioritize and publish an initial list
of approved drugs for which additional pediatric informa-
tion may produce health benefits in the pediatric popu-
lation. The Secretary shall annually update the list.
‘‘(c) MARKET EXCLUSIVITY
FOR ALREADY-MAR-
KETED DRUGS.—If the Secretary makes a written request
for pediatric studies (which may include a time frame for
completing such studies) concerning a drug identified in
the list described in subsection (b) to the holder of an ap-
proved application under section 505(b)(1) for the drug,
the holder agrees to the request, and the studies are com-
pleted within any such time frame and the reports thereof
submitted in accordance with subsection (d)(2) or com-
pleted within any such time frame and the reports thereof
accepted in accordance with subsection (d)(3)—
‘‘(1)(A) the period during which an application
may 
not 
be 
submitted 
under 
subsections
(c)(3)(D)(ii) and (j)(4)(D)(ii) of section 505 shall be
five years and six months rather than five years, and
the references in subsections (c)(3)(D)(ii) and
(j)(4)(D)(ii) of section 505 to four years, to forty-
eight months, and to seven and one-half years shall
be deemed to be four and one-half years, fifty-four
months, and eight years, respectively; or
‘‘(B) the period of market exclusivity under
subsections (c)(3)(D) (iii) and (iv) and (j)(4)(D) (iii)
and (iv) of section 505 shall be three years and six
months rather than three years; and
‘‘(2)(A) if the drug is the subject of—
‘‘(i) a listed patent for which a certification
has 
been 
submitted 
under 
section
505(b)(2)(A)(ii) or (j)(2)(A)(vii)(II) and for
which pediatric studies were submitted prior to
the expiration of the patent (including any pat-
ent extensions), or
‘‘(ii) a listed patent for which a certifi-
cation has been submitted under section
505(b)(2)(A)(iii) 
or 
section
505(j)(2)(A)(vii)(III),
the period during which an application may not be
approved 
under 
section 
505(c)(3) 
or 
section
505(j)(4)(B) shall be extended by a period of six
months after the date the patent expires (including
any patent extensions); or
‘‘(B) if the drug is the subject of a listed patent
for which a certification has been submitted under
section 
505(b)(2)(A)(iv) 
or 
section
505(j)(2)(A)(vii)(IV), and in the patent infringement
litigation resulting from the certification the court
determines that the patent is valid and would be in-
fringed, the period during which an application may
not be approved under section 505(c)(3) or section
505(j)(4)(B) shall be extended by a period of six
months after the date the patent expires (including
any patent extensions).
‘‘(d) CONDUCT OF PEDIATRIC STUDIES.—
‘‘(1) AGREEMENT
FOR
STUDIES.—The Sec-
retary may, pursuant to a written request for stud-
ies, after consultation with—
‘‘(A) the sponsor of an application for an
investigational new drug under section 505(i),
‘‘(B) the sponsor of an application for a
drug under section 505(b)(1), or
‘‘(C) the holder of an approved application
for a drug under section 505(b)(1),
agree with the sponsor or holder for the conduct of
pediatric studies for such drug.
‘‘(2) WRITTEN
PROTOCOLS
TO
MEET
THE
STUDIES REQUIREMENT.—If the sponsor or holder
and the Secretary agree upon written protocols for
the studies, the studies requirement of subsection
(a) or (c) is satisfied upon the completion of the
studies and submission of the reports thereof in ac-
cordance with the original written request and the