I 
110TH CONGRESS 
2D SESSION 
H. R. 6752 
To amend the Public Health Service Act to provide grants or contracts 
for prescription drug education and outreach for healthcare providers 
and their patients. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 31, 2008 
Mr. PALLONE (for himself and Mr. WAXMAN) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
A BILL 
To amend the Public Health Service Act to provide grants 
or contracts for prescription drug education and outreach 
for healthcare providers and their patients. 
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 ‘‘Independent Drug 
Education and Outreach Act of 2008’’. 
SEC. 2. PRESCRIPTION DRUG EDUCATION AND OUTREACH. 
Part A of title IX of the Public Health Service Act 
(42 U.S.C. 299 et seq.) is amended by adding at the end 
the following: 
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‘‘SEC. 904. PRESCRIPTION DRUG EDUCATION AND OUT-
REACH. 
‘‘(a) IN GENERAL.—The Secretary, acting through 
the Director, shall establish a program to award grants 
or contracts— 
‘‘(1) under subsection (b) for the development 
and production of educational materials concerning 
the evidence available on the relative safety, relative 
effectiveness, and relative cost of prescription drugs, 
non-prescription drugs, and non-drug interventions 
for treating selected conditions, for distribution to 
healthcare providers who prescribe such drugs and 
their patients; and 
‘‘(2) under subsection (c) for the development 
and implementation of a program to appropriately 
train and deploy health professionals to educate phy-
sicians and other drug prescribers concerning the 
relative safety, relative effectiveness, and relative 
cost of prescription drugs, non-prescription drugs, 
and non-drug interventions for treating selected con-
ditions. 
‘‘(b) EDUCATIONAL MATERIAL GRANTS
OR CON-
TRACTS.— 
‘‘(1) IN
GENERAL.—The Secretary, acting 
through the Director, shall award grants or con-
tracts to eligible entities for the development and 
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production of educational materials concerning the 
evidence available on the relative safety, relative ef-
fectiveness, and relative cost of prescription drugs, 
non-prescription drugs, and non-drug interventions 
for treating selected conditions, for presentation to 
healthcare providers who prescribe such drugs and 
their patients. 
‘‘(2) ELIGIBLE ENTITIES.—To be eligible to re-
ceive a grant or contract under paragraph (1) an en-
tity shall— 
‘‘(A) be a non-profit or governmental enti-
ty that is able to demonstrate clinical expertise, 
including— 
‘‘(i) a medical school; 
‘‘(ii) an academic medical center; 
‘‘(iii) a school of pharmacy; 
‘‘(iv) a medical society; 
‘‘(v) a pharmacist society; 
‘‘(vi) a research institute; and 
‘‘(vii) any other entity determined ap-
propriate by the Secretary; 
‘‘(B) receive no support from any entity 
that manufactures products used to treat the 
medical conditions discussed, or from any orga-
nization funded by such entities, during the pe-
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riod beginning 1 year prior to the submission of 
an application under this paragraph and ending 
1 year after the date on which the grant or con-
tract is received; and 
‘‘(C) submit to the Secretary an applica-
tion at such time, in such manner, and con-
taining such information as the Secretary may 
require, including— 
‘‘(i) information on the conditions for 
which the entity will develop and produce 
educational materials using grant or con-
tract funds; and 
‘‘(ii) a plan for ensuring the effective-
ness of such education materials and for 
interacting with entities receiving grants or 
contracts under subsection (c). 
‘‘(3) CRITERIA
FOR
AWARDING
GRANTS
OR 
CONTRACTS.—In evaluating grant or contract appli-
cations received under this subsection, the Secretary 
shall take into consideration— 
‘‘(A) the capacity of the entities to perform 
the activities described in paragraph (4); 
‘‘(B) the conditions that the educational 
materials involved will relate to, with a pref-
erence for minimizing redundancy; and 
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‘‘(C) the quality of the proposed edu-
cational materials involved, including— 
‘‘(i) whether materials are based upon 
peer-reviewed sources or based upon sci-
entific research which conforms to the ac-
cepted standards of experimental design, 
data collection, analysis, and interpreta-
tion; 
‘‘(ii) the likelihood that the materials 
will accurately reflect the comprehensive 
body of available evidence that is accepted 
within the practice of medicine; and 
‘‘(iii) the adequacy of the methods to 
be used to analyze the studies proposed to 
be relied upon. 
‘‘(4) USE
OF
FUNDS.—An entity shall use 
amounts received under a grant or contract under 
this subsection to— 
‘‘(A) develop educational materials of the 
type described in paragraph (1), including 
monographs, brochures, readily available ref-
erence cards, handouts for patients, and other 
materials in either written or electronic formats 
(including electronic formats compatible with e- 
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prescribing) determined appropriate by the Sec-
retary; 
‘‘(B) conduct tests concerning the effec-
tiveness of such educational materials with 
healthcare providers and their patients; and 
‘‘(C) prepare and submit to the Director 
the educational materials by condition, and a 
report that provides evidence supporting the ac-
curacy of the information and findings in the 
educational materials, including studies relied 
upon to prepare such materials, a description of 
the methods used to analyze those studies, and 
any studies with conflicting findings that were 
not included in the educational materials. 
‘‘(5) REVIEW OF EDUCATIONAL MATERIALS.— 
‘‘(A) IN GENERAL.—The Director shall re-
view and approve proposed educational mate-
rials submitted under paragraph (4)(C) within 
90 days of the receipt of such materials. 
‘‘(B) CLEARANCE OF EDUCATIONAL MATE-
RIALS.—With respect to educational materials 
that have been reviewed and approved by the 
Director, the Secretary shall permit the grantee 
or contractor involved to include on such edu-
cational materials the following statement: 
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