136 
(1) the Office of Minority Health in the Office 
of the Secretary of Health and Human Services; 
(2) the National Centers for Minority Health 
and Health Disparities in the National Institutes of 
Health; and 
(3) the Office of Minority Health in the Centers 
for Disease Control and Prevention. 
(e) AUTHORIZATION OF APPROPRIATIONS.—For the 
purpose of carrying out this section, there are authorized 
to be appropriated $10,000,000 for fiscal year 2006, and 
such sums may be necessary for each of fiscal years 2007 
through 2012. 
SEC. 408. OFFICE OF MINORITY AFFAIRS AT THE FOOD AND 
DRUG ADMINISTRATION. 
Chapter IX of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 391 et seq.) is amended by adding at the 
end the following: 
‘‘SEC. 908. OFFICE OF MINORITY AFFAIRS. 
‘‘(a) IN GENERAL.—Not later than 60 days after the 
date of enactment of this section, the Secretary shall es-
tablish within the Office of the Commissioner of Food and 
Drugs an Office of Minority Affairs (referred to in this 
section as the ‘Office’). 
‘‘(b) DUTIES.—The Office shall be responsible for the 
coordination and facilitation of activities of the Food and 
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137 
Drug Administration to improve minority health and 
healthcare and to reduce racial and ethnic disparities in 
health and healthcare, which shall include— 
‘‘(1) promoting policies in the development and 
review of medical products that reduce racial and 
ethnic disparities in health and healthcare; 
‘‘(2) encouraging appropriate data collection, 
analysis, and dissemination of racial and ethnic dif-
ferences using, at a minimum, the categories de-
scribed in the 1997 Office of Management and 
Budget standards, in response to different therapies 
in both adult and pediatric populations; 
‘‘(3) providing, in coordination with other ap-
propriate government agencies, education, training, 
and support to increase participation of minority pa-
tients and physicians in clinical trials; 
‘‘(4) collecting and analyzing data using, at a 
minimum, the categories described in the 1997 Of-
fice of Management and Budget standards, on the 
number of participants from minority racial and eth-
nic backgrounds in clinical trials used to support 
medical product approvals; 
‘‘(5) the identification of methods to reduce lan-
guage and literacy barriers; and 
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138 
‘‘(6) publishing an annual report about the ac-
tivities of the Food and Drug Administration per-
taining to minority health. 
‘‘(c) STAFF.—The staff of the Office shall include— 
‘‘(1) one or more individuals with expertise in 
the design and conduct of clinical trials of drugs, bi-
ological products, and medical devices; and 
‘‘(2) one or more individuals with expertise in 
therapeutic classes or disease states for which med-
ical evidence suggests a difference based on race or 
ethnicity. 
‘‘(d) COORDINATION.—In carrying out its duties 
under this section, the Office shall coordinate with— 
‘‘(1) the Office of Minority Health in the Office 
of the Secretary of Health and Human Services; 
‘‘(2) the National Center for Minority Health 
and Health Disparities in the National Institutes of 
Health; and 
‘‘(3) the Office of Minority Health in the Cen-
ters for Disease Control and Prevention. 
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—For the 
purpose of carrying out this section, there are authorized 
to be appropriated such sums as may be necessary for 
each of the fiscal years 2007 through 2012.’’. 
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139 
SEC. 409. SAFETY AND EFFECTIVENESS OF DRUGS WITH 
RESPECT TO RACIAL AND ETHNIC BACK-
GROUND. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by adding after section 505B the following: 
‘‘SEC. 505C. SAFETY AND EFFECTIVENESS OF DRUGS WITH 
RESPECT TO RACIAL AND ETHNIC BACK-
GROUND. 
‘‘(a) PRE-APPROVAL STUDIES.—If there is evidence 
that there may be a disparity on the basis of racial or 
ethnic background as to the safety or effectiveness of a 
drug, then— 
‘‘(1)(A) the investigations required under sec-
tion 505(b)(1)(A) shall include adequate and well- 
controlled investigations of the disparity; or 
‘‘(B) the evidence required under section 351(a) 
of the Public Health Service Act for approval of a 
biologics license application for the drug shall in-
clude adequate and well-controlled investigations of 
the disparity; and 
‘‘(2) if the investigations confirm that there is 
a disparity, the labeling of the drug shall include ap-
propriate information about the disparity. 
‘‘(b) POST-MARKET STUDIES.— 
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