Patient Experience in Research Act of 2017

Patient Experience in Research Act of 2017

This bill requires the Food and Drug Administration to carry out a pilot project under which sponsors of new drugs or biological products agree to evaluate: (1) the distress experienced by patients in clinical trials for medications intended to treat a serious condition, and (2) the effects of providing support to distressed patients on the outcome of a clinical trial. The user fee is waived for new drug applications that include data from such an evaluation.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2244 Introduced in House (IH)]

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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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Patient Experience in Research Act 
of 2017''.

SEC. 2. PILOT PROJECT FOR EVALUATION OF PSYCHOLOGICAL AND SOCIAL 
              DISTRESS EXPERIENCED BY PATIENTS IN CERTAIN CLINICAL 
              TRIALS.

    (a) In General.--The Secretary shall carry out a pilot project 
under which--
            (1) no more than 3 sponsors each agree to evaluate--
                    (A) the psychological and social distress 
                experienced by patients participating in a qualified 
                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
                    (B) the effects of providing psychological and 
                social support to any such patients showing signs of 
                distress on the primary outcome measures in the 
                clinical trial; and
            (2) the Secretary waives the fee that would otherwise apply 
        under section 736(a)(1) of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 379h(a)(1)) to the submission by the respective 
        sponsor of one human drug application for such drug or 
        biological product that includes the data resulting from such 
        evaluation.
    (b) Selection.--The Secretary shall select the sponsors referred to 
in subsection (a) on a competitive basis not later than the date that 
is 2 years after the date of enactment of this Act.
    (c) Meeting.--The Secretary shall grant at least one meeting to 
each sponsor selected under subsection (b) for the specific purpose of 
discussing the activities to be carried out by the sponsor pursuant to 
this Act.
    (d) Definitions.--In this Act:
            (1) The term ``biological product'' has the meaning given 
        to such term in section 351 of the Public Health Service Act 
        (42 U.S.C. 262).
            (2) The term ``drug'' has the meaning given to such term in 
        section 201 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 321).
            (3) The term ``human drug application'' has the meaning 
        given to such term in section 735 of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 379g).
            (4) The term ``qualified clinical trial'' means a clinical 
        trial in which all participating patients will be enrolled not 
        later than the date that is 5 years after the date of the 
        enactment of this Act.
            (5) The term ``Secretary'' means the Secretary of Health 
        and Human Services, acting through the Commissioner of Food and 
        Drugs.
            (6) The term ``sponsor'' means the sponsor of a drug or 
        biological product.
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