II 

110TH CONGRESS 

2D SESSION S. 3396 

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 SENATE OF THE UNITED STATES 

JULY 31, 2008 

Mr. KOHL (for himself, Mr. DURBIN, Mr. KENNEDY, and Mr. CASEY) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Independent Drug 

5 Education and Outreach Act of 2008’’. 

6 SEC. 2. PRESCRIPTION DRUG EDUCATION AND OUTREACH. 

7 Part A of title IX of the Public Health Service Act 

8 (42 U.S.C. 299 et seq.) is amended by adding at the end 

9 the following: 


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1 ‘‘SEC. 904. PRESCRIPTION DRUG EDUCATION AND OUT2 REACH. 

3 ‘‘(a) IN GENERAL.—The Secretary, acting through 

4 the Director, shall establish a program to award grants 

5 or contracts— 

6 ‘‘(1) under subsection (b) for the development 

7 and production of educational materials concerning 

8 the evidence available on the relative safety, relative 

9 effectiveness, and relative cost of prescription drugs, 

10 non-prescription drugs, and non-drug interventions 

11 for treating selected conditions, for distribution to 

12 healthcare providers who prescribe such drugs and 

13 their patients; and 

14 ‘‘(2) under subsection (c) for the development 

15 and implementation of a program to appropriately 

16 train and deploy health professionals to educate phy17 sicians and other drug prescribers concerning the 

18 relative safety, relative effectiveness, and relative 

19 cost of prescription drugs, non-prescription drugs, 

20 and non-drug interventions for treating selected con21 ditions. 

22 ‘‘(b) EDUCATIONAL MATERIAL GRANTS OR CON23 TRACTS.— 

24 ‘‘(1) IN GENERAL.—The Secretary, acting 

25 through the Director, shall award grants or con26 tracts to eligible entities for the development and 


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1 production of educational materials concerning the 

2 evidence available on the relative safety, relative ef3 fectiveness, and relative cost of prescription drugs, 

4 non-prescription drugs, and non-drug interventions 

5 for treating selected conditions, for presentation to 

6 healthcare providers who prescribe such drugs and 

7 their patients. 

8 ‘‘(2) ELIGIBLE ENTITIES.—To be eligible to re9 ceive a grant or contract under paragraph (1) an en10 tity shall— 

11 ‘‘(A) be a non-profit or governmental enti12 ty that is able to demonstrate clinical expertise, 

13 including— 

14 ‘‘(i) a medical school; 

15 ‘‘(ii) an academic medical center; 

16 ‘‘(iii) a school of pharmacy; 

17 ‘‘(iv) a medical society; 

18 ‘‘(v) a pharmacist society; 

19 ‘‘(vi) a research institute; and 

20 ‘‘(vii) any other entity determined ap21 propriate by the Secretary; 

22 ‘‘(B) receive no support from any entity 

23 that manufactures products used to treat the 

24 medical conditions discussed, or from any orga25 nization funded by such entities, during the peVerDate Aug 31 2005 22:33 Aug 04, 2008 Jkt 069200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S3396.IS S3396

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1 riod beginning 1 year prior to the submission of 

2 an application under this paragraph and ending 

3 1 year after the date on which the grant or con4 tract is received; and 

5 ‘‘(C) submit to the Secretary an applica6 tion at such time, in such manner, and con7 taining such information as the Secretary may 

8 require, including— 

9 ‘‘(i) information on the conditions for 

10 which the entity will develop and produce 

11 educational materials using grant or con12 tract funds; and 

13 ‘‘(ii) a plan for ensuring the effective14 ness of such education materials and for 

15 interacting with entities receiving grants or 

16 contracts under subsection (c). 

17 ‘‘(3) CRITERIA FOR AWARDING GRANTS OR

18 CONTRACTS.—In evaluating grant or contract appli19 cations received under this subsection, the Secretary 

20 shall take into consideration— 

21 ‘‘(A) the capacity of the entities to perform 

22 the activities described in paragraph (4); 

23 ‘‘(B) the conditions that the educational 

24 materials involved will relate to, with a pref25 erence for minimizing redundancy; and 


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1 ‘‘(C) the quality of the proposed edu2 cational materials involved, including— 

3 ‘‘(i) whether materials are based upon 

4 peer-reviewed sources or based upon sci5 entific research which conforms to the ac6 cepted standards of experimental design, 

7 data collection, analysis, and interpreta8 tion; 

9 ‘‘(ii) the likelihood that the materials 

10 will accurately reflect the comprehensive 

11 body of available evidence that is accepted 

12 within the practice of medicine; and 

13 ‘‘(iii) the adequacy of the methods to 

14 be used to analyze the studies proposed to 

15 be relied upon. 

16 ‘‘(4) USE OF FUNDS.—An entity shall use 

17 amounts received under a grant or contract under 

18 this subsection to— 

19 ‘‘(A) develop educational materials of the 

20 type described in paragraph (1), including 

21 monographs, brochures, readily available ref22 erence cards, handouts for patients, and other 

23 materials in either written or electronic formats 

24 (including electronic formats compatible with eVerDate Aug 31 2005 22:33 Aug 04, 2008 Jkt 069200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S3396.IS S3396

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1 prescribing) determined appropriate by the Sec2 retary; 

3 ‘‘(B) conduct tests concerning the effec4 tiveness of such educational materials with 

5 healthcare providers and their patients; and 

6 ‘‘(C) prepare and submit to the Director 

7 the educational materials by condition, and a 

8 report that provides evidence supporting the ac9 curacy of the information and findings in the 

10 educational materials, including studies relied 

11 upon to prepare such materials, a description of 

12 the methods used to analyze those studies, and 

13 any studies with conflicting findings that were 

14 not included in the educational materials. 

15 ‘‘(5) REVIEW OF EDUCATIONAL MATERIALS.— 

16 ‘‘(A) IN GENERAL.—The Director shall re17 view and approve proposed educational mate18 rials submitted under paragraph (4)(C) within 

19 90 days of the receipt of such materials. 

20 ‘‘(B) CLEARANCE OF EDUCATIONAL MATE21 RIALS.—With respect to educational materials 

22 that have been reviewed and approved by the 

23 Director, the Secretary shall permit the grantee 

24 or contractor involved to include on such edu25 cational materials the following statement: 


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1 ‘These materials were compiled under a grant 

2 issued by the Department of Health and 

3 Human Services.’. 

4 ‘‘(C) UPDATE OF MATERIALS.—As needed, 

5 but not later than 2 years after the date on 

6 which the educational materials were approved 

7 by the Director, the grantee or contractor in8 volved shall submit updated materials to the Di9 rector, including the studies used to develop 

10 such updates. 

11 ‘‘(6) AVAILABILITY.—The Director shall ensure 

12 that educational materials and reports developed 

13 under a grant or contract under this subsection shall 

14 be made publically available and accessible, including 

15 through the Internet website of the Agency. 

16 ‘‘(c) PRESCRIBER EDUCATION AND OUTREACH PRO17 GRAM.— 

18 ‘‘(1) IN GENERAL.—The Secretary, acting 

19 through the Director, shall award 10 grants or con20 tracts to eligible entities for the development and im21 plementation of programs to appropriately train and 

22 deploy healthcare professionals to educate physicians 

23 and other drug prescribers concerning the relative 

24 safety, relative effectiveness, and relative cost of pre25 scription drugs and their alternatives as described in 


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1 subsection (a)(2), and to distribute the educational 

2 materials developed under subsection (b) to physi3 cians and other drug prescribers. 

4 ‘‘(2) ELIGIBLE ENTITIES.—To be eligible to re5 ceive a grant or contract under paragraph (1) an en6 tity shall— 

7 ‘‘(A) be— 

8 ‘‘(i) a public entity, including a State 

9 or county; 

10 ‘‘(ii) a non-profit private entity; 

11 ‘‘(iii) a partnership between a public 

12 entity and a non-profit private entity; or 

13 ‘‘(iv) an academic institution; 

14 ‘‘(B) receive no support from any entity 

15 that manufactures products used to treat the 

16 medical conditions discussed, or from any orga17 nization funded by such entities, during the pe18 riod beginning 1 year prior to the submission of 

19 an application under this paragraph and ending 

20 1 year after the date on which the grant or con21 tract is received; and 

22 ‘‘(C) submit to the Secretary an applica23 tion at such time, in such manner, and con24 taining such information as the Secretary may 

25 require. 


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1 ‘‘(3) CRITERIA FOR AWARDING GRANTS OR

2 CONTRACTS.—In evaluating grant or contract appli3 cations received under this subsection, the Secretary 

4 shall take into consideration— 

5 ‘‘(A) the capacity of the entities to perform 

6 the activities described in paragraph (4); 

7 ‘‘(B) the service areas of the entity’s pro8 grams, in order to minimize overlap; 

9 ‘‘(C) the plans of the entities involved to 

10 provide incentives for physicians and other pre11 scribers to participate in the education pro12 gram, such as the availability of continuing 

13 medical education credits; and 

14 ‘‘(D) the methods proposed to provide the 

15 educational materials through outreach and 

16 interaction with prescribers in a setting, and 

17 with a communications plan, designed to en18 hance the likelihood that prescribers will par19 ticipate, and will use the information to improve 

20 the relative safety, relative effectiveness, and 

21 relative cost of medication utilization. 

22 ‘‘(4) USE OF FUNDS.—An entity shall use 

23 amounts received under a grant or contract under 

24 this subsection to carry out the following activities: 


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1 ‘‘(A) To hire and provide training to 

2 nurses, pharmacists, or other individuals with 

3 an appropriate clinical background to enable 

4 such individuals to provide information and 

5 educational outreach concerning the relative 

6 safety, relative effectiveness, and relative cost of 

7 prescription drugs and their alternatives as de8 scribed in subsection (a)(2) to healthcare pro9 viders who prescribe drugs in a manner that 

10 prescribers find useful, convenient, and time ef11 ficient. 

12 ‘‘(B) To identify healthcare providers who 

13 will receive office visits from individuals who re14 ceive training under this subsection. Preference 

15 for such office visits shall be given to healthcare 

16 providers with a large number of total patients 

17 or large number of patients receiving care 

18 through Federal health programs including the 

19 Medicare and Medicaid programs under titles 

20 XVIII and XIX of the Social Security Act. 

21 ‘‘(C) To conduct office visits to healthcare 

22 providers who prescribe drugs. 

23 ‘‘(D) To conduct other educational out24 reach activities with respect to healthcare proVerDate Aug 31 2005 22:33 Aug 04, 2008 Jkt 069200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S3396.IS S3396

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1 viders who prescribe drugs, as approved by the 

2 Secretary. 

3 ‘‘(E) To conduct an evaluation of the effec4 tiveness of the program involved in changing 

5 prescribing behavior and improving the quality 

6 of medication use. 

7 ‘‘(d) REGULATIONS.—The Secretary shall promul8 gate such regulations as may be required to carry out this 

9 section, including regulations to prevent conflicts of inter10 est, to ensure the accuracy and timeliness of the informa11 tion in the educational materials, and to promote the effec12 tiveness of the prescriber education and outreach program. 

13 ‘‘(e) EVALUATION.—The Secretary shall conduct an 

14 evaluation of the effectiveness of the educational materials 

15 and the prescriber education and outreach program under 

16 this section. 

17 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There 

18 is authorized to be appropriated, such sums as may be 

19 necessary to carry out this section.’’. 

Æ 


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