Section 1 Short title
This Act may be cited as the “Patient Experience in Research Act of 2017”.
Patient Experience in Research Act of 2017
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.
Sec. 2 Pilot project for evaluation of psychological and social distress experienced by patients in certain clinical trials
In general— The Secretary shall carry out a pilot project under which—
no more than 3 sponsors each agree to evaluate—
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
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
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.
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.
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.
Definitions— In this Act:
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).
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).
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).
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.
The term Secretary means the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs.
The term sponsor means the sponsor of a drug or biological product.