II 

111TH CONGRESS 

1ST SESSION S. 1142 

To amend the Federal Food, Drug, and Cosmetic Act with respect to inclusion 

of effectiveness information in drug and device labeling and advertising. 

IN THE SENATE OF THE UNITED STATES 

MAY 21, 2009 

Mr. REED (for himself and Ms. MIKULSKI) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act with 

respect to inclusion of effectiveness information in drug 

and device labeling and advertising. 

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 ‘‘Informed Health Care 

5 Decision Making Act’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds the following: 

8 (1) National randomized controlled trials have 

9 found that replacing the brief summary of drug adVerDate Nov 24 2008 18:12 May 26, 2009 Jkt 079200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1142.IS S1142

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1 vertisements with a drug facts box improved con2 sumer knowledge and judgments. In such trials, con3 sumers who were presented with a drug facts box 

4 more accurately perceived the side effects and bene5 fits of a drug, and were more than twice as likely 

6 to choose the superior drug. 

7 (2)(A) In 2007, the Institute of Medicine con8 ducted a workshop that highlighted that the public 

9 has a limited understanding of the benefits and risks 

10 of drugs. The workshop also highlighted that it is 

11 important to— 

12 (i) provide patients and physicians with the 

13 best possible information for making informed 

14 decisions about the use of pharmaceuticals; 

15 (ii) employ quantitative and standardized 

16 approaches when trying to evaluate pharma17 ceutical benefit-risk; and 

18 (iii) develop and validate improved tools for 

19 communicating pharmaceutical benefit-risk in20 formation to patients and physicians. 

21 (B) The general agreement of the workshop 

22 was that the Food and Drug Administration should 

23 pilot test a drug facts box. 

24 (3) On February 27, 2009, the Food and Drug 

25 Administration’s Risk Communication Advisory 


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1 Committee made the following unanimous rec2 ommendations: 

3 (A) The Food and Drug Administration 

4 should adopt a single standard document for 

5 communicating essential information about 

6 pharmaceuticals. 

7 (B) That standard document should in8 clude quantitative summaries of risks and bene9 fits, along with use and precaution information. 

10 (C) The Food and Drug Administration 

11 should adopt the drug facts box format as its 

12 standard. 

13 SEC. 3. PRESENTATION OF DRUG BENEFIT AND RISK IN14 FORMATION. 

15 (a) IN GENERAL.—The Secretary of Health and 

16 Human Services (referred to in this Act as the ‘‘Sec17 retary’’), acting through the Commissioner of Food and 

18 Drugs, shall determine whether standardized, quantitative 

19 summaries of the benefits and risks of drugs in a tabular 

20 or drug facts box format, or any alternative format, in 

21 the labeling and print advertising of such drugs would im22 prove health care decisionmaking by clinicians and pa23 tients and consumers. 

24 (b) REVIEW AND CONSULTATION.—In making the 

25 determination under subsection (a), the Secretary shall reVerDate Nov 24 2008 00:52 May 28, 2009 Jkt 079200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1142.IS S1142

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1 view all available scientific evidence and consult with drug 

2 manufacturers, clinicians, patients and consumers, experts 

3 in health literacy, and representatives of racial and ethnic 

4 minorities. 

5 (c) REPORT.—Not later than 1 year after the date 

6 of enactment of this Act, the Secretary shall submit to 

7 the Congress a report that provides— 

8 (1) the determination by the Secretary under 

9 subsection (a); and 

10 (2) the reasoning and analysis underlying that 

11 determination. 

12 (d) AUTHORITY.— 

13 (1) IN GENERAL.—If the Secretary determines 

14 under subsection (a) that standardized, quantitative 

15 summaries of the benefits and risks of drugs in a 

16 tabular or drug facts box format, or any alternative 

17 format, in the labeling and print advertising of such 

18 drugs would improve health care decisionmaking by 

19 clinicians and patients and consumers, then the Sec20 retary, not later than 1 year after the date of sub21 mission of the report under subsection (c), shall pro22 mulgate regulations as necessary to implement such 

23 format. 

24 (2) OBJECTIVE AND UP-TO-DATE INFORMA25 TION.—In carrying out paragraph (1), the Secretary 


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1 shall ensure that the information presented in a 

2 summary described under such paragraph is objec3 tive and up-to-date, and is the result of a review 

4 process that considers the totality of published and 

5 unpublished data. 

6 (3) POSTING OF INFORMATION.—In carrying 

7 out paragraph (1), the Secretary shall post the in8 formation presented in a summary described under 

9 such paragraph on the Internet Web site of the 

10 Food and Drug Administration. 

11 SEC. 4. STANDARDS FOR COMPARATIVE CLINICAL EFFEC12 TIVENESS INFORMATION. 

13 (a) IN GENERAL.—The Secretary, acting through the 

14 Commissioner of Food and Drugs, shall establish and peri15 odically update methodological standards and criteria for 

16 the sources of evidence and the adequacy and degree of 

17 evidence that are appropriate for inclusion of comparative 

18 clinical effectiveness information in labeling and advertise19 ments under subsections (f), (n)(3), and (r) of section 502 

20 of the Federal Food, Drug, and Cosmetic Act (as amended 

21 by section 5). 

22 (b) REQUIREMENTS.—The standards and criteria es23 tablished under subsection (a) shall ensure that compara24 tive clinical effectiveness information provides reliable and 

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1 making, adheres to rigorous scientific standards, and is 

2 produced through a transparent process that includes con3 sultation with stakeholders. 

4 (c) CONSULTATION.—In carrying out subsection (a), 

5 the Secretary shall consult with manufacturers of drugs 

6 and devices, clinicians, patients and consumers, experts in 

7 health literacy, and representatives of racial and ethnic 

8 minorities. 

9 (d) DEFINITION.—For purposes of this section, the 

10 term ‘‘comparative clinical effectiveness’’ means the clin11 ical outcomes, effectiveness, safety, and clinical appro12 priateness of a drug or device in comparison to 1 or more 

13 drugs or devices, respectively, approved to prevent, diag14 nose, or treat the same health condition for the same pa15 tient demographic subpopulation. 

16 SEC. 5. DISCLOSURE OF COMPARATIVE CLINICAL EFFEC17 TIVENESS INFORMATION. 

18 (a) COMPARATIVE CLINICAL EFFECTIVENESS.—Sec19 tion 201 of the Federal Food, Drug, and Cosmetic Act 

20 (21 U.S.C. 321) is amended by adding at the end the fol21 lowing: 

22 ‘‘(rr) The term ‘comparative clinical effectiveness’ 

23 means the clinical outcomes, effectiveness, safety, and 

24 clinical appropriateness of a drug or device in comparison 

25 to 1 or more drugs or devices, respectively, approved to 


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1 prevent, diagnose, or treat the same health condition for 

2 the same patient demographic subpopulation, on the basis 

3 of research that meets standards adopted by the Secretary 

4 under section 4 of the Informed Health Care Decision 

5 Making Act.’’. 

6 (b) LABELING AND ADVERTISING INFORMATION.— 

7 Section 502 of the Federal Food, Drug, and Cosmetic Act 

8 (21 U.S.C. 352) is amended— 

9 (1) in subsection (f), by striking ‘‘for use; and 

10 (2)’’ and inserting ‘‘for use; (2) such information in 

11 brief summary relating to comparative clinical effec12 tiveness as shall be required in regulations which 

13 shall be issued by the Secretary in accordance with 

14 the procedure specified in section 701(a); and (3)’’; 

15 (2) in subsection (n)(3), by striking ‘‘and effec16 tiveness’’ and inserting ‘‘effectiveness, and compara17 tive clinical effectiveness (or a disclosure that there 

18 is no such information relating to comparative clin19 ical effectiveness if another drug has been approved 

20 for the same use),’’; and 

21 (3) in subsection (r)— 

22 (A) by striking ‘‘In the case of any’’ and 

23 inserting ‘‘(1) In the case of any’’; 

24 (B) by striking ‘‘(1) a true’’ and inserting 

25 ‘‘(A) a true’’; 


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1 (C) by striking ‘‘(2) a brief’’ and inserting 

2 ‘‘(B) a brief’’; and 

3 (D) by striking ‘‘and contraindications’’ 

4 and inserting ‘‘contraindications, and, if appro5 priate after taking into consideration the type 

6 of device, effectiveness and comparative clinical 

7 effectiveness (or a disclosure that there is no 

8 such information relating to comparative clin9 ical effectiveness if another device has been ap10 proved for the same use)’’. 

Æ 


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