(C) the number of drugs for which pedi-
atric testing has been done, for which a period
of market exclusivity has been granted, and for
which labeling changes required the use of the
dispute resolution process established pursuant
to the amendments, together with a description
of the outcomes of such process, including a de-
scription of the disputes and the recommenda-
tions of the advisory committee.
(2) The economic impact of the amendments
made by this Act, including an estimate of—
(A) costs to taxpayers in the form of high-
er expenditures by Medicaid and other govern-
ment programs;
(B) costs to consumers as a result of any
delay in the availability of lower cost generic
equivalents of drugs tested and granted exclu-
sivity pursuant to such amendments, and loss
of revenue by the generic drug industry and any
other affected industry as a result of any such
delay; and
(C) benefits to the government, to private
insurers, and to consumers resulting from de-
creased health care costs, including—
(i) decreased hospitalizations, due to
more appropriate and more effective use of
medications in children as a result of test-
ing and re-labeling because of such amend-
ments;
(ii) direct and indirect benefits associ-
ated with fewer physician visits not related
to hospitalization;
(iii) benefits to children from missing
less time at school and being less affected
by chronic illnesses, thereby allowing a bet-
ter quality of life;
(iv) benefits to consumers from lower
health insurance premiums due to lower
treatment costs and hospitalization rates;
and
(v) benefits to employers from reduced
need for employees to care for family mem-
bers.
(3) The nature and types of studies in children
of drugs granted a period of market exclusivity pur-
suant to the amendments made by this Act, includ-
ing a description of the complexity of such studies,
the number of study sites necessary to obtain appro-
priate data, and the numbers of children involved in
any clinical studies, and the cost of such studies for
each type of study identified.
(4) The increased pediatric research capability,
both private and government-funded, associated with
the amendments made by this Act.
SEC. 16. MINORITY CHILDREN AND PEDIATRIC-EXCLU-
SIVITY PROGRAM.
(a) PROTOCOLS FOR PEDIATRIC STUDIES.—Section
505A of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355a) is amended in subsection (c)(2) (as redesig-
nated by section 2(a)(2) of this Act) by inserting after
the first sentence the following: ‘‘In reaching an agree-
ment regarding written protocols, the Secretary shall take
into account adequate representation of children of ethnic
and racial minorities.’’.
(b) STUDY BY GENERAL ACCOUNTING OFFICE.—
(1) IN GENERAL.—The Comptroller General of
the United States shall conduct a study for the pur-
pose of determining the following:
(A) The extent to which children of ethnic
and racial minorities are adequately represented
in studies under section 505A of the Federal
Food, Drug, and Cosmetic Act; and to the ex-
tent ethnic and racial minorities are not ade-
quately represented, the reasons for such under
representation and recommendations to increase
such representation.
(B) Whether the Food and Drug Adminis-
tration has appropriate management systems to
monitor the representation of the children of
ethnic and racial minorities in such studies.
(C) Whether drugs used to address dis-
eases that disproportionately affect racial and
ethnic minorities are being studied for their
safety and effectiveness under section 505A of
the Federal Food, Drug, and Cosmetic Act.
(2) DATE CERTAIN FOR COMPLETING STUDY.—
Not later than January 10, 2003, the Comptroller
General shall complete the study required in para-
graph (1) and submit to the Congress a report de-
scribing the findings of the study.
SEC. 17. TECHNICAL AND CONFORMING AMENDMENTS.
Section 505A of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355a) is amended—
(1)(A) by striking ‘‘(j)(4)(D)(ii)’’ each place
such term appears and inserting ‘‘(j)(5)(D)(ii)’’; and
(B) by striking ‘‘(j)(4)(D)’’ each place such
term appears and inserting ‘‘(j)(5)(D)’’; and
(2)(A) in subsection (c) (as redesignated by sec-
tion 2(a)(2) of this Act), in each of paragraphs (1)
through (3), by striking ‘‘subsection (a) or (c)’’ and
inserting ‘‘subsection (a) or (b)’’; and
(B) in subsection (d) (as so redesignated), in
the last sentence, by striking ‘‘subsection (a) or (c)’’
and inserting ‘‘subsection (a) or (b)’’.
Passed the House of Representatives November 15,
2001.
Attest:
Clerk.