I 

115TH CONGRESS 

1ST SESSION H. R. 2244 

To direct the Secretary of Health and Human Services to carry out a 

pilot project under which no more than 3 sponsors agree to evaluate 

the psychological and social distress experienced by patients participating 

in a clinical trial, conducted by the respective sponsor, of a drug or 

biological product that is intended to treat a serious or life-threatening 

disease or condition, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 28, 2017 

Mr. LANCE (for himself and Ms. DEGETTE) introduced the following bill; 

which was referred to the Committee on Energy and Commerce 

A BILL 

To direct the Secretary of Health and Human Services to 

carry out a pilot project under which no more than 

3 sponsors agree to evaluate the psychological and social 

distress experienced by patients participating in a clinical 

trial, conducted by the respective sponsor, of a drug 

or biological product that is intended to treat a serious 

or life-threatening disease or condition, 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, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Patient Experience in 

3 Research Act of 2017’’. 

4 SEC. 2. PILOT PROJECT FOR EVALUATION OF PSYCHO5 LOGICAL AND SOCIAL DISTRESS EXPERI6 ENCED BY PATIENTS IN CERTAIN CLINICAL 

7 TRIALS. 

8 (a) IN GENERAL.—The Secretary shall carry out a 

9 pilot project under which— 

10 (1) no more than 3 sponsors each agree to 

11 evaluate— 

12 (A) the psychological and social distress 

13 experienced by patients participating in a quali14 fied clinical trial, conducted by the respective 

15 sponsor, of a drug or biological product that is 

16 intended to treat a serious or life-threatening 

17 disease or condition; and 

18 (B) the effects of providing psychological 

19 and social support to any such patients showing 

20 signs of distress on the primary outcome meas21 ures in the clinical trial; and 

22 (2) the Secretary waives the fee that would oth23 erwise apply under section 736(a)(1) of the Federal 

24 Food, Drug, and Cosmetic Act (21 U.S.C. 

25 379h(a)(1)) to the submission by the respective 

26 sponsor of one human drug application for such 


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1 drug or biological product that includes the data re2 sulting from such evaluation. 

3 (b) SELECTION.—The Secretary shall select the spon4 sors referred to in subsection (a) on a competitive basis 

5 not later than the date that is 2 years after the date of 

6 enactment of this Act. 

7 (c) MEETING.—The Secretary shall grant at least one 

8 meeting to each sponsor selected under subsection (b) for 

9 the specific purpose of discussing the activities to be car10 ried out by the sponsor pursuant to this Act. 

11 (d) DEFINITIONS.—In this Act: 

12 (1) The term ‘‘biological product’’ has the 

13 meaning given to such term in section 351 of the 

14 Public Health Service Act (42 U.S.C. 262). 

15 (2) The term ‘‘drug’’ has the meaning given to 

16 such term in section 201 of the Federal Food, Drug, 

17 and Cosmetic Act (21 U.S.C. 321). 

18 (3) The term ‘‘human drug application’’ has the 

19 meaning given to such term in section 735 of the 

20 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

21 379g). 

22 (4) The term ‘‘qualified clinical trial’’ means a 

23 clinical trial in which all participating patients will 

24 be enrolled not later than the date that is 5 years 

25 after the date of the enactment of this Act. 


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1 (5) The term ‘‘Secretary’’ means the Secretary 

2 of Health and Human Services, acting through the 

3 Commissioner of Food and Drugs. 

4 (6) The term ‘‘sponsor’’ means the sponsor of 

5 a drug or biological product. 

Æ 


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