II 

114TH CONGRESS 

1ST 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, and Mr. BENNET) introduced the following bill; which was read 

twice and referred to the Committee on Health, Education, Labor, and 

Pensions 

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’’. 

6 SEC. 2. PUBLIC DISCLOSURE OF SAFETY AND EFFECTIVE7 NESS DATA IN ACTION PACKAGE. 

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

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


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

2 the following: 

3 ‘‘(vii) Documentation of the patient en4 gagement assessment efforts made as part of 

5 the review, including identification of the pa6 tient-focused drug development tools and data 

7 reviewed in informing the decision to approve 

8 the application, and including an explanation of 

9 whether the following were reviewed or exam10 ined: 

11 ‘‘(I) Patient population benefit and 

12 risk data. 

13 ‘‘(II) Draft or final guidances issued 

14 by the Food and Drug Administration. 

15 ‘‘(III) Patient-reported or caregiver16 reported outcomes data. 

17 ‘‘(IV) Patient preference data. 

18 ‘‘(V) Perspectives of patients serving 

19 on advisory committees or participating in 

20 medical product development proceedings. 

21 ‘‘(VI) Perspectives of medical and sci22 entific professionals with relevant exper23 tise. 

24 ‘‘(VII) Other measures to assess the 

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1 ment tools, as determined by the Sec2 retary.’’; and 

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

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

5 prepare and submit to the Committee on Health, 

6 Education, Labor, and Pensions of the Senate and 

7 the Committee on Energy and Commerce of the 

8 House of Representatives an annual report summa9 rizing the data collected from the action packages 

10 under subparagraph (C)(vii). Such report shall in11 clude an assessment by the Food and Drug Adminis12 tration of the trends of such agency with respect to 

13 the use of patient-focused drug development tools in 

14 reviewing applications under subsection (b) and sec15 tion 351 of the Public Health Service Act.’’. 

16 SEC. 3. GUIDANCE TO PATIENTS AND INDUSTRY ON PA17 TIENT-FOCUSED DRUG DEVELOPMENT. 

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

19 Secretary of Health and Human Services (referred to in 

20 this section as the ‘‘Secretary’’), acting through the Com21 missioner of Food and Drugs, shall publish guidance 

22 that— 

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1 tient advocacy organizations and industry sponsors 

2 for the purposes of— 

3 (A) developing patient-focused drug devel4 opment tools; and 

5 (B) obtaining patient perspectives on med6 ical products under development; 

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

8 Administration with respect to advocacy and indus9 try collaborations that would be permitted to develop 

10 such tools and obtain such perspectives; and 

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

12 Administration with respect to activities that would 

13 not be permitted for such purposes. 

14 (b) TIMING.—The Secretary shall— 

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

16 enactment of this Act, publish proposed guidance 

17 under this section; and 

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

19 publication of such proposed guidance, and after 

20 providing an opportunity for the public to comment 

21 on such proposed guidance, publish final guidance 

22 under this section. 

Æ 


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