I 
111TH CONGRESS 
1ST SESSION H. R. 1859 
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 
APRIL 1, 2009 
Mr. PALLONE (for himself, Mr. WAXMAN, Mr. RANGEL, and Mr. STARK) in-
troduced the following bill; which was referred to the Committee on En-
ergy 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 2009’’. 
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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production of educational materials concerning the 
evidence available on the relative safety, relative ef-
fectiveness, and relative cost of prescription drugs, 
nonprescription 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 nonprofit or governmental entity 
that is able to demonstrate clinical expertise, in-
cluding— 
‘‘(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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‘These materials were compiled under a grant 
issued by the Department of Health and 
Human Services.’. 
‘‘(C) UPDATE OF MATERIALS.—As needed, 
but not later than 2 years after the date on 
which the educational materials were approved 
by the Director, the grantee or contractor in-
volved shall submit updated materials to the Di-
rector, including the studies used to develop 
such updates. 
‘‘(6) AVAILABILITY.—The Director shall ensure 
that educational materials and reports developed 
under a grant or contract under this subsection shall 
be made publicly available and accessible, including 
through the Internet website of the Agency. 
‘‘(c) PRESCRIBER EDUCATION AND OUTREACH PRO-
GRAM.— 
‘‘(1) IN
GENERAL.—The Secretary, acting 
through the Director, shall award 10 grants or con-
tracts to eligible entities for the development and im-
plementation of programs to appropriately train and 
deploy healthcare professionals to educate physicians 
and other drug prescribers concerning the relative 
safety, relative effectiveness, and relative cost of pre-
scription drugs and their alternatives as described in 
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subsection (a)(2), and to distribute the educational 
materials developed under subsection (b) to physi-
cians and other drug prescribers. 
‘‘(2) ELIGIBLE ENTITIES.—To be eligible to re-
ceive a grant or contract under paragraph (1) an en-
tity shall— 
‘‘(A) be— 
‘‘(i) a public entity, including a State 
or county; 
‘‘(ii) a nonprofit private entity; 
‘‘(iii) a partnership between a public 
entity and a nonprofit private entity; or 
‘‘(iv) an academic institution; 
‘‘(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-
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. 
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‘‘(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 service areas of the entity’s pro-
grams, in order to minimize overlap; 
‘‘(C) the plans of the entities involved to 
provide incentives for physicians and other pre-
scribers to participate in the education pro-
gram, such as the availability of continuing 
medical education credits; and 
‘‘(D) the methods proposed to provide the 
educational materials through outreach and 
interaction with prescribers in a setting, and 
with a communications plan, designed to en-
hance the likelihood that prescribers will par-
ticipate, and will use the information to improve 
the relative safety, relative effectiveness, and 
relative cost of medication utilization. 
‘‘(4) USE
OF
FUNDS.—An entity shall use 
amounts received under a grant or contract under 
this subsection to carry out the following activities: 
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‘‘(A) To hire and provide training to 
nurses, pharmacists, or other individuals with 
an appropriate clinical background to enable 
such individuals to provide information and 
educational outreach concerning the relative 
safety, relative effectiveness, and relative cost of 
prescription drugs and their alternatives as de-
scribed in subsection (a)(2) to healthcare pro-
viders who prescribe drugs in a manner that 
prescribers find useful, convenient, and time ef-
ficient. 
‘‘(B) To identify healthcare providers who 
will receive office visits from individuals who re-
ceive training under this subsection. Preference 
for such office visits shall be given to healthcare 
providers with a large number of total patients 
or large number of patients receiving care 
through Federal health programs including the 
Medicare and Medicaid programs under titles 
XVIII and XIX of the Social Security Act. 
‘‘(C) To conduct office visits to healthcare 
providers who prescribe drugs. 
‘‘(D) To conduct other educational out-
reach activities with respect to healthcare pro-
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viders who prescribe drugs, as approved by the 
Secretary. 
‘‘(E) To conduct an evaluation of the effec-
tiveness of the program involved in changing 
prescribing behavior and improving the quality 
of medication use. 
‘‘(d) REGULATIONS.—The Secretary shall promul-
gate such regulations as may be required to carry out this 
section, including regulations to prevent conflicts of inter-
est, to ensure the accuracy and timeliness of the informa-
tion in the educational materials, and to promote the effec-
tiveness of the prescriber education and outreach program. 
‘‘(e) EVALUATION.—The Secretary shall conduct an 
evaluation of the effectiveness of the educational materials 
and the prescriber education and outreach program under 
this section. 
‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated such sums as may be 
necessary to carry out this section.’’. 
Æ 
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