II 

Calendar No. 413 

114TH CONGRESS 

2D SESSION S. 1597 

To enhance patient engagement in the medical product development process, 

and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

JUNE 17, 2015 

Mr. WICKER (for himself, Ms. KLOBUCHAR, Ms. COLLINS, Mr. FRANKEN, Mr. 

ISAKSON, Mr. BENNET, Mr. DONNELLY, Mr. COTTON, and Ms. MURKOWSKI) introduced the following bill; which was read twice and referred 

to the Committee on Health, Education, Labor, and Pensions 

APRIL 5, 2016 

Reported by Mr. ALEXANDER, with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

A BILL 

To enhance patient engagement in the medical product 

development process, and for other purposes. 

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 ‘‘Patient-Focused Im5 pact Assessment Act of 2015’’. 


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1 SEC. 2. PUBLIC DISCLOSURE OF SAFETY AND EFFECTIVE2 NESS DATA IN ACTION PACKAGE. 

3 Paragraph (2) of section 505(l) of the Federal Food, 

4 Drug, and Cosmetic Act (21 U.S.C. 355(l)) is amended— 

5 (1) in subparagraph (C), by adding at the end 

6 the following: 

7 ‘‘(vii) Documentation of the patient en8 gagement assessment efforts made as part of 

9 the review, including identification of the pa10 tient-focused drug development tools and data 

11 reviewed in informing the decision to approve 

12 the application, and including an explanation of 

13 whether the following were reviewed or exam14 ined: 

15 ‘‘(I) Patient population benefit and 

16 risk data. 

17 ‘‘(II) Draft or final guidances issued 

18 by the Food and Drug Administration. 

19 ‘‘(III) Patient-reported or caregiver20 reported outcomes data. 

21 ‘‘(IV) Patient preference data. 

22 ‘‘(V) Perspectives of patients serving 

23 on advisory committees or participating in 

24 medical product development proceedings. 


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1 ‘‘(VI) Perspectives of medical and sci2 entific professionals with relevant exper3 tise. 

4 ‘‘(VII) Other measures to assess the 

5 impact of patient-focused drug develop6 ment tools, as determined by the Sec7 retary.’’; and 

8 (2) by adding at the end the following: 

9 ‘‘(F) ANNUAL REPORTS.—The Secretary shall 

10 prepare and submit to the Committee on Health, 

11 Education, Labor, and Pensions of the Senate and 

12 the Committee on Energy and Commerce of the 

13 House of Representatives an annual report summa14 rizing the data collected from the action packages 

15 under subparagraph (C)(vii). Such report shall in16 clude an assessment by the Food and Drug Adminis17 tration of the trends of such agency with respect to 

18 the use of patient-focused drug development tools in 

19 reviewing applications under subsection (b) and sec20 tion 351 of the Public Health Service Act.’’. 

21 SEC. 3. GUIDANCE TO PATIENTS AND INDUSTRY ON PA22 TIENT-FOCUSED DRUG DEVELOPMENT. 

23 (a) PUBLICATION OF GUIDANCE; CONTENTS.—The 

24 Secretary of Health and Human Services (referred to in 

25 this section as the ‘‘Secretary’’), acting through the ComVerDate Sep 11 2014 20:57 Apr 05, 2016 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6401 E:\BILLS\S1597.RS S1597

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1 missioner of Food and Drugs, shall publish guidance 

2 that— 

3 (1) specifies how the Food and Drug Adminis4 tration views collaboration between patients or pa5 tient advocacy organizations and industry sponsors 

6 for the purposes of— 

7 (A) developing patient-focused drug devel8 opment tools; and 

9 (B) obtaining patient perspectives on med10 ical products under development; 

11 (2) specifies the position of the Food and Drug 

12 Administration with respect to advocacy and indus13 try collaborations that would be permitted to develop 

14 such tools and obtain such perspectives; and 

15 (3) specifies the position of the Food and Drug 

16 Administration with respect to activities that would 

17 not be permitted for such purposes. 

18 (b) TIMING.—The Secretary shall— 

19 (1) not later than 6 months after the date of 

20 enactment of this Act, publish proposed guidance 

21 under this section; and 

22 (2) not later than 6 months after the date of 

23 publication of such proposed guidance, and after 

24 providing an opportunity for the public to comment 


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1 on such proposed guidance, publish final guidance 

2 under this section. 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Patient-Focused Impact 

5 Assessment Act of 2016’’. 

6 SEC. 2. PATIENT EXPERIENCE DATA. 

7 Section 569C of the Federal Food, Drug, and Cosmetic 

8 Act (21 U.S.C. 360bbb-8c) is amended— 

9 (1) in subsection (a)— 

10 (A) in the subsection heading, by striking 

11 ‘‘IN GENERAL’’ and inserting ‘‘PATIENT EN12 GAGEMENT IN DRUGS AND DEVICES’’; 

13 (B) by redesignating paragraphs (1) and 

14 (2) as subparagraphs (A) and (B), respectively, 

15 and adjusting the margins accordingly; and 

16 (C) by striking ‘‘The Secretary’’ and insert17 ing the following: 

18 ‘‘(1) IN GENERAL.—The Secretary’’; 

19 (2) by redesignating subsections (b) through (e) 

20 as paragraphs (2) through (5), respectively, and ad21 justing the margins accordingly; and 

22 (3) by adding at the end the following: 

23 ‘‘(b) STATEMENT OF PATIENT EXPERIENCE.— 

24 ‘‘(1) IN GENERAL.—Following the approval of an 

25 application that was submitted under section 505(b) 


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1 of this Act or section 351(a) of the Public Health 

2 Service Act (42 U.S.C. 262(a)) at least 6 months after 

3 the date of enactment of the Patient-Focused Impact 

4 Assessment Act of 2016, the Secretary shall make pub5 lic a brief statement regarding the patient experience 

6 data and related information, if any, submitted and 

7 reviewed as part of such application. The Secretary 

8 shall include in the statement information on whether 

9 the data and information described in paragraph (2) 

10 were submitted and reviewed as part of such applica11 tion. 

12 ‘‘(2) DATA AND INFORMATION.—The data and 

13 information referred to in paragraph (1) are— 

14 ‘‘(A) patient experience data; 

15 ‘‘(B) information on patient-focused drug 

16 development tools; and 

17 ‘‘(C) other relevant information, as deter18 mined by the Secretary. 

19 ‘‘(c) PATIENT EXPERIENCE DATA.—For purposes of 

20 this section, the term ‘patient experience data’ includes data 

21 that— 

22 ‘‘(1) are collected by any persons (including pa23 tients, family members and caregivers of patients, pa24 tient advocacy organizations, disease research founda25 tions, researchers, and drug manufacturers); and 


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1 ‘‘(2) are intended to provide information about 

2 patients’ experiences with a disease or condition, in3 cluding— 

4 ‘‘(A) the impact of such disease or condi5 tion, or a related therapy, on patients’ lives; and 

6 ‘‘(B) patient preferences with respect to 

7 treatment of such disease or condition.’’. 

8 SEC. 3. GUIDANCE TO PATIENTS AND INDUSTRY ON PA9 TIENT-FOCUSED DRUG DEVELOPMENT. 

10 (a) PUBLICATION OF GUIDANCE DOCUMENTS.—Not 

11 later than 6 months after the date of enactment of this Act, 

12 the Secretary of Health and Human Services (referred to 

13 in this section as the ‘‘Secretary’’), acting through the Com14 missioner of Food and Drugs, shall develop a plan to issue 

15 draft and final versions of one or more guidance documents, 

16 over a period of 5 years, regarding the collection of patient 

17 experience data, and the use of such data and related infor18 mation in drug development. Not later than 18 months after 

19 that date of enactment, the Secretary shall issue a draft 

20 version of at least one such guidance document. Not later 

21 than 1 year after the public comment period on the draft 

22 document ends, the Secretary shall issue a final version of 

23 that document. 


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1 (b) PATIENT EXPERIENCE DATA.—For purposes of 

2 this section, the term ‘‘patient experience data’’ includes 

3 data that— 

4 (1) are collected by any persons (including pa5 tients, family members and caregivers of patients, pa6 tient advocacy organizations, disease research founda7 tions, researchers, and drug manufacturers); and 

8 (2) are intended to provide information about 

9 patients’ experiences with a disease or condition, in10 cluding— 

11 (A) the impact of such disease or condition, 

12 or a related therapy, on patients’ lives; and 

13 (B) patient preferences with respect to 

14 treatment of such disease or condition. 

15 (c) CONTENTS.—The guidance documents described in 

16 subsection (a) shall address— 

17 (1) how a person seeking to collect patient expe18 rience data for submission to and proposed use by the 

19 Food and Drug Administration in regulatory deci20 sionmaking may— 

21 (A) submit initial concepts about how such 

22 person plans to gather patient experience data; 

23 (B) develop and collect patient experience 

24 data using methodologies that— 

25 (i) ensure data are accurate; 


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1 (ii) ensure data are representative of 

2 the intended population; and 

3 (iii) are relevant and objective; and 

4 (C) submit patient experience data, anal5 ysis, or other applicable related information, in6 cluding through a regulatory application, a pub7 lic docket, or other means; 

8 (2) how a person seeking to develop and submit 

9 proposed draft guidance relating to patient experience 

10 data for consideration by the Food and Drug Admin11 istration may submit such proposed draft guidance to 

12 the Food and Drug Administration; 

13 (3) the format and content required for submis14 sions under this section to the Food and Drug Admin15 istration, including with respect to the information 

16 described in paragraph (1); 

17 (4) how the Secretary intends to respond to sub18 missions under paragraph (1), if appropriate given 

19 the manner in which a submission is made, including 

20 any timeframe for response when such submission is 

21 not part of a regulatory application or other submis22 sion that has an associated timeframe for response; 

23 and 

24 (5) how, when the Commissioner of Food and 

25 Drugs determines appropriate, such Commissioner 


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1 anticipates using relevant patient experience data 

2 and related information, including with respect to the 

3 structured risk-benefit assessment framework described 

4 in section 505(d) of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 355(d)). 

6 SEC. 4. PATIENT INPUT EXEMPT FROM PAPERWORK REDUC7 TION ACT. 

8 Chapter 35 of title 44, United States Code, shall not 

9 apply to collections of information to which a response is 

10 voluntary, that are initiated by the Secretary under section 

11 3 of the Patient-Focused Impact Assessment Act of 2016. 

12 SEC. 5. REPORT TO CONGRESS ON PATIENT EXPERIENCE 

13 DRUG DEVELOPMENT. 

14 Not later than June 1 of 2021, 2026, and 2031, the 

15 Secretary of Health and Human Services, acting through 

16 the Commissioner of Food and Drugs, shall prepare and 

17 publish on the website of the Food and Drug Administra18 tion a report assessing the trends of the Food and Drug 

19 Administration with respect to the review of patient experi20 ence data and information on patient-focused drug develop21 ment tools as part of approved applications submitted 

22 under section 505(b) of the Federal Food, Drug, and Cos23 metic Act (21 U.S.C. 355(b)) and section 351(a) of the Pub24 lic Health Service Act (42 U.S.C. 262(a)). 


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Calendar No. 413 

114TH CONGRESS 

2D SESSION S. 1597 

A BILL 

To enhance patient engagement in the medical 

poses. product development process, and for other purAPRIL 5, 2016 

Reported with an amendment 


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